Specific energy consumed and methane yield with various chemo-mechanical pretreatment.
\\n\\n
Released this past November, the list is based on data collected from the Web of Science and highlights some of the world’s most influential scientific minds by naming the researchers whose publications over the previous decade have included a high number of Highly Cited Papers placing them among the top 1% most-cited.
\\n\\nWe wish to congratulate all of the researchers named and especially our authors on this amazing accomplishment! We are happy and proud to share in their success!
\\n"}]',published:!0,mainMedia:null},components:[{type:"htmlEditorComponent",content:'IntechOpen is proud to announce that 179 of our authors have made the Clarivate™ Highly Cited Researchers List for 2020, ranking them among the top 1% most-cited.
\n\nThroughout the years, the list has named a total of 252 IntechOpen authors as Highly Cited. Of those researchers, 69 have been featured on the list multiple times.
\n\n\n\nReleased this past November, the list is based on data collected from the Web of Science and highlights some of the world’s most influential scientific minds by naming the researchers whose publications over the previous decade have included a high number of Highly Cited Papers placing them among the top 1% most-cited.
\n\nWe wish to congratulate all of the researchers named and especially our authors on this amazing accomplishment! We are happy and proud to share in their success!
\n'}],latestNews:[{slug:"stanford-university-identifies-top-2-scientists-over-1-000-are-intechopen-authors-and-editors-20210122",title:"Stanford University Identifies Top 2% Scientists, Over 1,000 are IntechOpen Authors and Editors"},{slug:"intechopen-authors-included-in-the-highly-cited-researchers-list-for-2020-20210121",title:"IntechOpen Authors Included in the Highly Cited Researchers List for 2020"},{slug:"intechopen-maintains-position-as-the-world-s-largest-oa-book-publisher-20201218",title:"IntechOpen Maintains Position as the World’s Largest OA Book Publisher"},{slug:"all-intechopen-books-available-on-perlego-20201215",title:"All IntechOpen Books Available on Perlego"},{slug:"oiv-awards-recognizes-intechopen-s-editors-20201127",title:"OIV Awards Recognizes IntechOpen's Editors"},{slug:"intechopen-joins-crossref-s-initiative-for-open-abstracts-i4oa-to-boost-the-discovery-of-research-20201005",title:"IntechOpen joins Crossref's Initiative for Open Abstracts (I4OA) to Boost the Discovery of Research"},{slug:"intechopen-hits-milestone-5-000-open-access-books-published-20200908",title:"IntechOpen hits milestone: 5,000 Open Access books published!"},{slug:"intechopen-books-hosted-on-the-mathworks-book-program-20200819",title:"IntechOpen Books Hosted on the MathWorks Book Program"}]},book:{item:{type:"book",id:"2506",leadTitle:null,fullTitle:"Modern Information Systems",title:"Modern Information Systems",subtitle:null,reviewType:"peer-reviewed",abstract:'The development of modern information systems is a demanding task. 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She is also the present Global Harmonization Initiative (GHI) Ambassador to Sri Lanka.",institutionString:"Australian College of Business & Technology",position:null,outsideEditionCount:0,totalCites:0,totalAuthoredChapters:"10",totalChapterViews:"0",totalEditedBooks:"7",institution:null}],coeditorOne:null,coeditorTwo:null,coeditorThree:null,coeditorFour:null,coeditorFive:null,topics:[{id:"6",title:"Biochemistry, Genetics and Molecular Biology",slug:"biochemistry-genetics-and-molecular-biology"}],chapters:[{id:"74859",title:"An Antioxidant Defense System in Radiation-Resistant Bacterium Deinococcus geothermalis against Oxidative Stress",slug:"an-antioxidant-defense-system-in-radiation-resistant-bacterium-deinococcus-geothermalis-against-oxid",totalDownloads:23,totalCrossrefCites:0,authors:[null]},{id:"74893",title:"Endogenous Enzymatic Antioxidant Defense and Pathologies",slug:"endogenous-enzymatic-antioxidant-defense-and-pathologies",totalDownloads:19,totalCrossrefCites:0,authors:[null]},{id:"75042",title:"Micronutrient Antioxidants in the Chemoprevention of Breast Cancer and Effect on Breast Cancer Outcomes",slug:"micronutrient-antioxidants-in-the-chemoprevention-of-breast-cancer-and-effect-on-breast-cancer-outco",totalDownloads:32,totalCrossrefCites:0,authors:[null]},{id:"74753",title:"Evolutionary Strategies of Highly Functional Catalases for Adaptation to High H2O2 Environments",slug:"evolutionary-strategies-of-highly-functional-catalases-for-adaptation-to-high-h2o2-environments",totalDownloads:27,totalCrossrefCites:0,authors:[null]},{id:"74706",title:"The Role of Lycopene in Chronic Lung Diseases",slug:"the-role-of-lycopene-in-chronic-lung-diseases",totalDownloads:67,totalCrossrefCites:0,authors:[null]},{id:"74380",title:"Thiol Reduction and Cardiolipin Improve Complex I Activity and Free Radical Production in Liver Mitochondria of Streptozotocin-Induced Diabetic Rats",slug:"thiol-reduction-and-cardiolipin-improve-complex-i-activity-and-free-radical-production-in-liver-mito",totalDownloads:54,totalCrossrefCites:0,authors:[null]},{id:"74927",title:"Antioxidants in Female Reproductive Biology",slug:"antioxidants-in-female-reproductive-biology",totalDownloads:8,totalCrossrefCites:0,authors:[null]},{id:"74748",title:"Reappraisal of Dietary Phytochemicals for Coronavirus Infection: Focus on Hesperidin and Quercetin",slug:"reappraisal-of-dietary-phytochemicals-for-coronavirus-infection-focus-on-hesperidin-and-quercetin",totalDownloads:444,totalCrossrefCites:0,authors:[null]},{id:"75198",title:"Management of Diabetic Eye Disease using Carotenoids and Nutrients",slug:"management-of-diabetic-eye-disease-using-carotenoids-and-nutrients",totalDownloads:33,totalCrossrefCites:0,authors:[null]},{id:"74807",title:"Vitamin C and Sepsis",slug:"vitamin-c-and-sepsis",totalDownloads:40,totalCrossrefCites:0,authors:[null]},{id:"74793",title:"Phytochemical Antioxidants: Past, Present and Future",slug:"phytochemical-antioxidants-past-present-and-future",totalDownloads:40,totalCrossrefCites:0,authors:[null]},{id:"75026",title:"Role of Antioxidants Supplementation in the Treatment of Male Infertility",slug:"role-of-antioxidants-supplementation-in-the-treatment-of-male-infertility",totalDownloads:40,totalCrossrefCites:0,authors:[null]},{id:"75226",title:"Use of Selected Antioxidant-Rich Spices and Herbs in Foods",slug:"use-of-selected-antioxidant-rich-spices-and-herbs-in-foods",totalDownloads:19,totalCrossrefCites:0,authors:[null]},{id:"74790",title:"Antioxidant Activity: The Presence and Impact of Hydroxyl Groups in Small Molecules of Natural and Synthetic Origin",slug:"antioxidant-activity-the-presence-and-impact-of-hydroxyl-groups-in-small-molecules-of-natural-and-sy",totalDownloads:77,totalCrossrefCites:0,authors:[null]},{id:"74678",title:"Role of Secondary Metabolites to Attenuate Stress Damages in Plants",slug:"role-of-secondary-metabolites-to-attenuate-stress-damages-in-plants",totalDownloads:41,totalCrossrefCites:0,authors:[null]},{id:"74332",title:"The Two Sides of Dietary Antioxidants in Cancer Therapy",slug:"the-two-sides-of-dietary-antioxidants-in-cancer-therapy",totalDownloads:50,totalCrossrefCites:0,authors:[null]}],productType:{id:"1",title:"Edited Volume",chapterContentType:"chapter",authoredCaption:"Edited by"},personalPublishingAssistant:{id:"280415",firstName:"Josip",lastName:"Knapic",middleName:null,title:"Mr.",imageUrl:"https://mts.intechopen.com/storage/users/280415/images/8050_n.jpg",email:"josip@intechopen.com",biography:"As an Author Service Manager my responsibilities include monitoring and facilitating all publishing activities for authors and editors. 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This makes it necessary to find alternative energy sources which have a minimum impact on the environment. In this context, biogas is one of the sustainable energy sources that can be produced from many types of biomass including waste. AD technology is one of the most promising technologies, having the potential to convert various biomass into methane-rich biogas, a carbon-neutral alternative to fossil fuels. In addition, AD technology has a number of benefits including solids reduction, decreased odor, reduced greenhouse gas emissions, and increased income from non-market benefits compared to conventional waste treatment systems [1, 2]. In Germany, which is the leading country in this field, greater than 50% of the biogas potential results from energy crops treated in over 7000 biogas plants [3]. AD has wide application in sludge stabilization due to its low cost, energy recovery and minimized biosolids production.
\nAD system utilizes anaerobic microorganisms to convert the organic matter in the biomass, into biogas in an oxygen free environment. Biogas is the main byproduct of AD and contains about 60% methane by volume. Digestate is produced as a byproduct, which after an appropriate treatment can have agricultural applications as fertilizer [4]. It reduces organic matter to more stable solids by complex biochemical reactions. There are three consecutive steps of biological process in AD. The first step involves hydrolysis of complex organic matter into simpler compounds. The second step is the acidogenesis, which involves conversion of these organics to form organic acids and hydrogen. The final step is methane and carbon dioxide production from organic acids and hydrogen, by methanogens. The high methane content makes biogas a useful fuel that can displace natural gas in pipelines or be converted to electricity and heat. AD typically require long residence times, as certain anaerobic microorganisms have slow rate of growth. Long residence times lead to large volumes of tanks. Therefore, to improve digestion efficiency, the most efficient approach is to disrupt the chemical bonds in the material prone to hydrolysis [5]. Other factors limiting its performance are slow hydrolysis, low biodegradability, inhibition due to toxic compounds and toxic intermediates formed and poor methanogenesis. To overcome this recalcitrant property and to improve the degradation rate, a pretreatment prior to the AD process is introduced. Thus the goal of a pretreatment is to open up the structure of the substrate, making it more accessible for enzymatic attack [6] which aids in increasing biogas yield. The effects of various pretreatment methods highly differ, depending on the characteristics of the substrates and the pretreatment type. Recently, a lot of interest has been devoted to biomass disintegration and solubilization techniques in order to overcome the biological limitations of anaerobic digestion. The pretreatment techniques include mechanical treatment [7], ultrasonic treatment [8, 9] and biological hydrolysis with enzymes [10, 11, 12], alkaline treatment [13], oxidative treatments using ozone [14, 15], microwave irradiation [5, 16, 17], thermal treatment [18] thermochemical [19], sono-thermal [20, 21, 22] etc.
\nAD process is mediated through four main steps—hydrolysis, acidogenesis, acetogenesis and methanogenesis. These are carried out by a consortium of microorganisms: acidogenic bacteria, acetogenic bacteria and methanogenic bacteria [23]. The microbial community of the anaerobic process is very complex. There are two prokaryotic kingdoms that closely interact with each other: Bacteria and Archaea. The first step involves hydrolysis of complex organic matter into simpler compounds. In the second step, the acidogenesis of these organics take place to form organic acids and hydrogen. In the final step, methane and carbon dioxide are produced from organic acids and hydrogen by archael methanogens.
\nFigure 1 summarizes the overall process of AD. Organic matter consists of particulate, water-insoluble polymers such as carbohydrates, lipids and proteins. Insoluble polymers cannot penetrate cellular membranes and are therefore not directly available to the microorganisms. During hydrolysis, appropriate strains of hydrolytic bacteria excrete hydrolytic enzymes [23] which break up the insoluble polymers to soluble mono and oligomers. Carbohydrates are converted to sugars, lipids are broken down to long-chain fatty acids and proteins are split into amino acids [24]. These soluble molecules are converted by acidogens to acetic acid and other longer volatile fatty acids, alcohols, carbon dioxide and hydrogen on acidogenesis. The foremost acids produced are acetic acid (CH3COOH), propionic acid (CH3CH2COOH), butyric acid (CH3CH2CH2COOH), and ethanol (C2H5OH). Other acid formers are Clostridium, Peptococcusanerobus, Lactobacillus, and Actinomyces. The next process is acetogenesis during which, the longer volatile fatty acids and alcohols are oxidized by proton-reducing acetogens to acetic acid and hydrogen. An acetogenesis reaction is shown below:
\nSchematic representation of anaerobic digestion (source: https://www.e-education.psu.edu/egee439).
In the last step of the process, methanogens use acetic acid or carbon dioxide and hydrogen, to produce methane and carbon dioxide. For mesophilic bacteria, the optimal methane production rate is mostly reached at 35–37°C. The thermophilic methanogens differ from the mesophilic one and their maximum methanogenic activity is reached at about 55°C. A thermophilic digestion process can sustain a higher organic loading compared to a mesophilic one. But the thermophilic process produces gas with a lower methane concentration [25] and is more sensitive to toxicants [26]. Methanogens are also sensitive towards changes in temperature than the other species, because of their slower growth rate in the reactor environment. Methanogenesis occurs at neutral pH- in the range of 6.5–7.5, although optimum lies at pH 7.0–7.2 [26]. If, for example, a temperature shift affects the methanogens negatively, there can be a build-up of volatile fatty acids (VFAs). This lowers the pH which further affects the methanogens in a negative way which leads to a vicious circle of negative feedback. The methanogenesis reactions can be expressed as follows [27] in Eqs. (2)–(4):
\nThe digestion efficiency and its stability can vary significantly depending upon the wastewater characteristics and type and design of the treatment system. The longer a substrate is kept under proper reaction conditions, the more complete its degradation will become. Longer retention time demands the provision of reactor with large volume for a given amount of substrate to be treated. On the other hand, with shorter retention time washout of microorganism takes place with a lower overall degradation [25]. Therefore, these two effects have to be balanced in the design of AD for the efficient and proper operation of the full scale reactor. This needs operation of AD through skilled supervision for optimal performance.
\nSeveral renewable matters have been tried for biogas production which are classified into crop biomass such as maize, wheat, barley, sweet sorghum, etc.; organic wastes such as municipal solid waste, municipal and industrial wastewater sludge, animal manure, and residues from various processing; energy crops like sunflower, rape, jatropha, etc.; crop residues which include banana stem, barley straw, rice straw, softwood spruce, etc.; and non-conventional biomass like glycerol, microalgae, etc. [28, 29, 30, 31, 32, 33, 34]. Figures 2–4 show the effect of pretreatment of lignocellulosic, sludge and macroalgal biomass respectively.
\nEffect of pretreatment on lignocellulosic biomass (source: https://www.e-education.psu.edu/egee439/node/653).
Effect of pretreatment on sludge biomass.
Effect of pretreatment of macroalgal biomass.
The diverse composition of lignocellulose biomass and the interactions between fractions make its structure very complex and resistant to deconstruction. Cellulose and hemicellulose are polysaccharides that can be hydrolyzed to simple sugars. Lignin which acts as a support to the cell structure, embedding cellulose and hemicellulose, hinders the susceptibility to microbial attack during hydrolysis process [35]. The aim of pretreatment is to break the lignin layer that protects the cellulose and hemicellulose, in order to make the biomass more accessible for digestion [6]. Pretreatment also helps to decrease the crystallinity of cellulose and to increase the porosity. Furthermore, biomass such as fruit wastes is easily degraded but result in low yield due to the presence of inhibitors.
\nKeratin, which is present in horns and feathers, is an insoluble protein in which the polypeptides chain is tightly packed and highly cross-linked with disulfide bonds, hydrogen bonds, and hydrophobic interactions [36]. This insoluble protein is extremely resistive to the proteolytic enzyme action, which is a major hindrance in the biological processing of these wastes. For such biomass, if the crosslinking between the polypeptides chain breaks, the keratin becomes more accessible and easier to digest. Contrarily, while keratin-rich waste is pretreated using a strong acid, alkali, or other harsh physicochemical methods, severe degradation and destruction of the keratin occurs [37].
\nActivated sludge, a bio product of aerobic wastewater treatment, can be a better raw material for generating energy because of its high organic content [38]. Secondary wastewater sludge consists of numerous microbial cells, the cell walls of which act as barriers against exo-enzyme degradation. Besides microbial cells, exocellular polymeric substances (EPS) comprise a major organic fraction in activated sludge floc structure and binding mechanisms of EPS to cations appear to be a significant factor determining the digestibility of activated sludge. Hence hydrolysis becomes the rate-limiting step and degree of degradation achieved is limited to 30–35% chemical oxygen demand (COD) reduction in conventional anaerobic sludge treatment [23]. Pretreatment of sludge is required to rupture the cell wall and to facilitate the release of intracellular matter into the aqueous phase, which improves the biodegradability thereby enhancing the AD with lower retention time and with higher biogas production [20].
\nThe macroalgal cell envelope made of thick and hard layer composed of complex proteins and carbohydrates with more mechanical power and high chemical resistance, restricts the attack of the biopolymers by methanogenic bacteria during AD [39]. Pretreatment leads to improvement in the liquefaction process, enhancing the biopolymer release [28]. Several pretreatment methods have been reported in detail, aiming to make these biomass viable to digestion by microorganisms, and increase the biogas yield. It is necessary to carry out the pretreatment at mild conditions to prevent excessive sugar degradation.
\nSeveral pretreatment processes such as ball mill [40], microwave irradiation [2], sodium hydroxide [13], steam explosion [41], ultrasonic [42], biological [43], ozonation [14] have been shown to enhance biodegradability of biomass by promoting the hydrolysis process. Since most available articles are addressed based on pretreatment of lignocellulosic biomass, this chapter is mainly focused towards sludge pretreatment.
\nThe lower hydrolysis rates during conventional AD process, results in higher hydraulic retention time (HRT) in the digester and larger digester volume, constitutes the prime drawbacks of the conventional AD [6]. The non-availability of the readily biodegradable, soluble organic matters and lower digestion rate constantly necessitates the pretreatment of sludge. Pretreatment of biomass enhances the AD, with lower retention time and with higher biogas production [17]. With the advancements in various pretreatment techniques like thermal, chemical, mechanical, biological and physical and several combinations such as physicochemical, biological–physicochemical, mechanical–chemical and thermal–chemical, biodegradability of sludge can be enhanced by several orders. Extensive research has been carried throughout the world to establish the best economically feasible pretreatment technology to enhance the digestibility of biomass [12]. Tables 1 and 2 show the specific energy consumed and methane yield with various chemo-mechanical and physico-chemical pretreatment.
\nS. No. | \nName of the pretreatment | \nSpecific energy consumed (KJ/kg TS) | \nSolubilization achieved (%) | \nBiomethane yield | \nReferences | \n
---|---|---|---|---|---|
1 | \nDisperser + alkali | \n4544 | \n24 | \n1391 ml | \nRani et al. [21] | \n
2 | \nThermo chemo disperser | \n3360.94 | \n18.6 | \n0.455 L/g VS | \nKavitha et al. [44] | \n
3 | \nChemo disperser | \n5013 | \n20 | \n0.522 L/g VS | \nPoornima Devi et al. [45] | \n
4 | \nSono alkaline | \n4172 | \n59 | \n0.108 ml/g VS removed | \nRani et al. [46] | \n
5 | \nThermo chemo sonic | \n5290.5 | \n27 | \n0.413 g COD/g COD | \nKavitha et al. [47] | \n
6 | \nCitric acid + ultrasonic | \n171.9 | \n22.7 | \n0.435 L/g VS | \nGayathri et al. [29] | \n
7 | \nFenton + ultrasonic | \n641 | \n34.4 | \n0.3 g COD/g COD | \nKavitha et al. [48] | \n
8 | \nThermo chemo sonic | \n5500 | \n35 | \n0.60 g COD/g COD | \nKavitha et al. [49] | \n
9 | \nDisperser + microwave | \n18,000 | \n22 | \n0.28 g COD/g COD | \nKavitha et al. [50] | \n
10 | \nChemo mechanical | \n7377 | \n38 | \n50 ml/g VS removed | \nKavitha et al. [51] | \n
11 | \nSonic mediated biological | \n2.45 | \n23 | \n0.19 d1 | \nKavitha et al. [52] | \n
12 | \nChemo thermo disperser | \n174 | \n60 | \n0.84 g COD/g COD | \nKavitha et al. [43] | \n
13 | \nSurfactant sonic | \n5120 | \n24.7 | \n0.24 g/g COD | \nUshani et al. [53] | \n
14 | \nChemo disperser | \n3312.6 | \n15 | \n0.14 g COD/g COD | \nTamilarasan et al. [28] | \n
15 | \nSurfactant + sonic | \n5400 | \n26 | \n0.6 g/g COD | \nSanthi et al. [54] | \n
16 | \nDisperser + bacterial | \n9.5 | \n22.4 | \n0. 279 g COD/g COD | \nBanu et al. [55] | \n
17 | \nUltrasound + microwave | \n16,700 | \n33.2 | \n0.3 L/g COD | \nKavitha et al. [56] | \n
18 | \nSurfactant + sonic | \n9600 | \n23.9 | \n0.239 g/g COD | \nTamilarasan et al. [57] | \n
Specific energy consumed and methane yield with various chemo-mechanical pretreatment.
S. No. | \nName of the pretreatment | \nSpecific energy consumed (KJ/kg TS) | \nSolubilization achieved (%) | \nBiomethane yield | \nReferences | \n
---|---|---|---|---|---|
1. | \nMicrowave | \n1844 | \n18.6 | \n0.162 ml/g VS removed | \nRani et al. [33] | \n
2. | \nMicrowave + citric acid | \n14,000 | \n31 | \n0.615 L/g VS | \nEbenezer et al. [38] | \n
3. | \nMicrowave + surfactant | \n14,000 | \n28 | \n0.47 L/g VS | \nEbenezer et al. [58] | \n
4. | \nMicrowave + H2O2 | \n18,600 | \n56 | \n0.323 L/g VS | \nEswari et al. [59] | \n
5. | \nH2O2 + microwave | \n18,910 | \n46.6 | \n250 ml/g VS | \nEswari et al. [60] | \n
6. | \nThermo ozone | \n141.02 | \n30.4 | \n0.32 g COD/g COD | \nKannah et al. [1] | \n
Specific energy consumed with various physico-chemical pretreatment.
In physical pretreatment, the structure of the biomass gets altered and the size of the particles reduced, by the application of physical force. This leads to an increase in the surface area of the particles thereby making it susceptible to microbial and enzymatic attacks, which enhances the AD process for methane production [61]. Physical pretreatment may be done by employing microwave irradiation, sonication, mechanical beating, deflaking, dispersing, extruding, refining, milling, and cavitation etc. [62].
\nMilling pretreatment is carried out, especially for lignocellulose and algal biomass to reduce the size of the substrate to break open the cellular structure, and improve their bio accessibility to the cell tissues, by increasing the specific surface area of the biomass [40]. Particle size reduction not only increases the rate of enzymatic degradation, but also reduces viscosity in digesters thus making mixing easier and can reduce the problems of floating layers. For effective hydrolysis of lignocellulose, beta particle size of 1–2 mm has been recommended [63]. Using three batch reactors, Motte et al. [40] demonstrated, treating straw particle milled to different sizes 0.25 mm, 1 mm and 10 mm followed during 62 days. They achieved the highest methane production for straw with 10 mm particle size (192 ± 25 Nm L/g VS) which was associated with a straw biodegradability of 43%.
\nThe most frequently applied cavitation techniques include acoustic cavitation, which is produced by passing ultrasonic waves through the liquid medium and hydrodynamic cavitation produced using hydraulic systems. In acoustic cavitation, microbubbles called cavitation were developed when the ultrasound waves propagate in a liquid medium, due to a repeating pattern of compressions and rarefactions. These cavitation expand to unstable size, and then rapidly collapse resulting in temperatures up to 5000 K and pressures up to 180 MPa. The rapid collapse of a numerous microbubbles generates powerful shear forces in the surrounding liquid, which damages the cell walls of microorganisms [21, 53]. However, higher sonication power level is reported to adversely affect the pretreatment process. At higher power level, bubbles are formed near the tip of the ultrasound transducer, which hinders the transfer of energy to the liquid medium [64].
\nIn the ultrasonic pretreatment study on waste activated sludge (WAS), Apul & Sanin [7] investigated an improvement in anaerobic biodegradability at 15 min of sonication. They achieved an increase in daily biogas production and methane production by 49 and 74% respectively compared to control in semi continuous reactors at a solid retention time (SRT) of 15 days and organic loading rate of 0.5 kg/m3 d. Zeynali et al. [42] studied the efficiency of ultrasonic pretreatment in improving biogas production from fruits and vegetable waste. They adopted three sonication times of 9, 18, 27 min operating at 20 kHz and amplitude of 80 μm on the substrate. The highest methane yield they obtained was at 18 min sonication with specific energy 2380 kJ/kg TS (Total solids) for a 12 d batch period, while longer exposure to sonication led to lower methane yield. The energy content of the biogas obtained by them was twice that of input energy for sonication. Alzate et al. [65] reported that, the sonication applied to macro algae at a specific energy input of 75 MJ/kg TS produced just 20% of the methane production. Upon increasing the specific energy to about 100–200 MJ/kg TS, they reported an increase in the methane production rate between 80 and 90%.
\nIn hydrodynamic systems, cavitation is generated by forcing fluid flow through cavitating devices, where pressure substantially drops. Many microbubbles formed as a consequence of this pressure drop subsequently collapse. The collapse of the cavitation, results in release of large magnitudes of energy which helps in dissolution of biomass and makes it more suitable for subsequent bacterial decomposition, improving biogas yield during the AD process [66]. They investigated the application of hydrodynamic cavitation (HC) for the pretreatment of wheat straw with an objective of enhancing the biogas production. They observed the methane yields of 31.8 ml with untreated wheat straw, 77.9 ml with HC pre-treated wheat straw and a maximum yield of 172.3 ml with the combined pre-treatment using KOH and HC.
\nDuring microwave irradiation the destruction of the microbial cells is caused by the disruption of the chemical (hydrogen) bonds in the cell walls and membranes, by polarized parts of macromolecules aligning with the poles of the electromagnetic field, which results in denaturation. Microwaves can induce an athermal effect in addition to their thermal effect due to dipole orientation, which results in possible breakage of hydrogen bonds and subsequently leads to the disintegration of the floc matrix [17]. They observed that, microbial cells exposed to MW showed greater damage at similar applied temperatures compared to conventional heating. Rincón et al. [67] studied the effect of a MW pre-treatment on olive mill solid residue to enhance its anaerobic digestibility. They carried out the experiment at a power of 800 W and temperature 50°C and observed a maximum methane yield of 395 ± 1 ml CH4/g VS for an applied specific energy 7660 kJ/kg TS. Beszédes et al. [16] focused on the effects of MW irradiation at different power levels on biodegradation and subsequent AD of sludge from the dairy and meat industry. Compared to their results obtained from conventional heat treatment of the same sludge, the MW treatment proved to increase the methane yield.
\nIn extrusion pretreatment, the biomass is allowed to experience heat, compression and shear force, which creates physical damage and chemical alterations of biomass cells while passing through the extruder. The extruder arrangement consists of single or twin screws that spin into a tight barrel, which is equipped with temperature control. When a biomass material passes through the barrel, it is exposed to friction and vigorous shearing causing an increase in temperature and pressure. When it exits the finishing end, the biomass material experiences a pressure release, which causes structural changes in the processed biomass enabling easy digestion in the subsequent step [61].
\nMaroušek [68] evaluated extrusion parameters of pelleted hay for maximal cumulative biogas production, and reported that, at optimal conditions of pressure 1.3 MPa, reaction time 7 min, and 8% dry matter, the maximal biogas production was 405 m3/ton TS (with 52.3% methane), which was about a 33% increase over the biogas yield of control. Novarino and Zanetti [69] employed extrusion pretreatment to improve biogas production from the organic fraction of municipal solid waste, resulting in a biogas yield of 800 L/kg VS containing about 60% methane content.
\nThermal pretreatment improves hydrolysis, with increased methane yield during subsequent anaerobic digestion. A wide range of temperatures has been studied, ranging from 60 to 270°C, but temperatures above 200°C have been found responsible for the production of recalcitrant soluble organics or toxic/inhibitory intermediates during the pretreatment process [70]. Many studies employed at an optimum thermal range of 160–180°C for hydrolysis of wastewater sludge have proved an increase in methane yield during AD. Higher temperatures lead to a sharp reduction in biodegradability of sludge hydrolysate, due to production of recalcitrant soluble organics or toxic/inhibitory intermediates during the process [71]. The effect of thermal treatment of anaerobic sludge on the disintegration of the remaining organic fraction was evaluated by Borges and Chernicharo [18]. At 75°C, they observed an increase of 30–35 times increase in the concentrations of protein, carbohydrate, lipid and COD and an increase of 50% in the biogas production, thus characterizing a higher biodegradability of the remaining organic fraction.
\nAcid pretreatment causes sludge disintegration and cell lysis which releases the intracellular organics, which become more bioavailable and thus increases the rate and efficiency of the digestion process [17]. In lignocellulosic biomass, the pretreatment results in the disruption of the Van der Waals forces, hydrogen bonds and covalent bonds that hold together the biomass components, which consequently causes the breaking of hemicellulose and the reduction of cellulose [72]. Devlin et al. [73] showed the improved effects of HCl pretreatment at pH 2 on subsequent digestion of WAS. In semi-continuous digestion experiments conducted for 12 day hydraulic retention time at 35°C, they found a 14.3% increase in methane yield compared to untreated WAS. Taherdanak et al. [74] used dilute sulfuric acid pretreatment, to improve the biomethane production from wheat plant under mesophilic anaerobic digestion. At 121°C, they obtained a maximum methane yield of 15.5% higher than that of the untreated wheat plant after pretreatment for 120 min.
\nThe mechanism of alkaline pretreatment mainly induces swelling of particulate organics at elevated pH, enabling the biomass cellular substances more susceptible to enzymatic action [24]. The complex cell gets damaged by the hydroxyl anions available in the alkali. In macroalgae, it enhances hydrolysis of RNA, organic liquefaction of proteins and saponification [28]. In lignocellulosic biomass, it causes swelling, delignification and de-esterification of intermolecular ester bonds. With the disintegration of the bonds the porosity and internal surface area of the biomass increases, the degree of polymerization and crystallinity decreases. This makes it more accessible for enzymes and bacteria [6]. Regarding WAS, at higher pH, the microbial cell walls are broken and intracellular material is released into the liquid phase.
\nStudies were explored by Banu et al. [13] to evaluate the advantage of sodium hydroxide (NaOH) for its higher sludge solubilization potential and lime. They conducted experiments at a fixed alkali strength (35 meq/l) and varying concentration of NaOH and lime to demonstrate the role of alkalis in solubilizing sludge. The highest solubilization they achieved, was at an optimum dosage of NaOH and lime 1.6 and 0.7 g/l respectively at time 3 h. Sambusiti et al. [75] investigated the effect of alkaline (NaOH) pretreatment on ensiled sorghum forage in semi continuous digesters. They observed that pretreatment with 10 g NaOH/100 g TS increased the methane yield by 25% compared to untreated sorghum without experiencing any inhibition of the process.
\nWet air oxidation is a pretreatment option that enhances contact between molecular oxygen and organic matter for the complete degradation of organic compounds into carbon dioxide and water. In order to achieve this, high temperature (and subsequently high pressure) conditions are required [22]. The correspondingly high pressure required is to maintain the high temperature conditions, as well as to help increase the concentration of dissolved oxygen, and thus oxidation rate. Chandra et al. [76] employed wet air oxidation to enhance the biodegradability of the complex biomethanated distillery effluent. They reported an enhanced biogas yield of pretreated effluent up to 2.8 times higher than the untreated effluent with methane content up to 64.14%.
\nOzone is a strong oxidant and hence powerful in oxidizing substrates. It has potential to degrade lignin in diverse feedstocks. It reacts with the polysaccharides, proteins, lipids and other recalcitrant compounds and transform them into biodegradable molecules. The ozonation process can result in efficient cell wall rupture and release of more soluble and easily biodegradable organics, which can be easily accessed and assimilated by anaerobic microorganisms. Thus it leads to improvement in the AD process [15].
\nAD of ozone pretreated excess sludge was studied by Goel et al. [14] through long-term operation of laboratory-scale reactors. They found that ozone pretreatment was effective in partially solubilizing the sludge solids and leading to subsequent improvement in anaerobic degradability. The extent of solubilization and digestion efficiency depended on the applied ozone doses. At 0.05 g O3/g TS, the AD efficiencies improved to about 59% as compared to 31% for the control run. Different process indicators like specific methane production and ammonia concentration in the reactor, also specify the higher observed solid degradation rates for ozonated sludge.
\nThe biological mediated pretreatment process is based on the function of multiple form of heterotrophic microbes. Complex biopolymers such as protein and carbohydrate can be transformed into simpler end products due to the action of various enzymes produced by the bacteria. The significance of biological pretreatment lies in the fact that is solubilizes the organic compounds present in the biomass with minimum energy, with no severe changes in substrate environment. Biological pretreatment is done with or without enzyme addition some of which can be produced endogenously by microorganisms present in the sludge. Some of the enzymes like protease, lipase, cellulase, alpha-amylase and dextranase [11] can effectively improve the hydrolysis rate and release of biopolymers to a large extent. Contrarily, these enzymes are more costly and difficult to preserve. Bonilla et al. [77] evaluated the potential for enzymatic pretreatment of pulp mill biosludge with protease from B. licheniformis for biodegradability. Carrying out BMP test, they arrived at a maximum improvement of 26% in biogas yield.
\nSaranya et al. [10] studied the impacts of phase separated disintegration pretreatment using calcium chloride (CaCl2) and bacteria. For their study a pH of 6.5, temperature of 40°C and treatment period of 42 h were the optimum conditions for pretreatment. In the initial phase, they achieved the floc disruption (deflocculation) with 0.06 g/g SS of CaCl2 and in the latter phase, cell disintegration through potent biosurfactant producing bacteria, Planococcus jake 01. They were able to achieve 17.14% SS reduction and 14.14% COD solubilization for deflocculated and bacterially pretreated sludge, which were comparatively higher than for sludge treated with bacteria alone. They observed a biogas yield potential for pretreated sludge of 0.322 L/g VS as against 0.145 L/g VS for control. Kavitha et al. [43] investigated the bacterial-based biological pretreatment on liquefaction of microalga Chlorella vulgaris with cellulase-secreting bacteria prior to anaerobic biodegradation. The biomethanation studies implied that bacterial pretreatment increased the bioavailability of biomass and hence methane generation. They arrived at a methane yield of nearly twice that of control.
\nFungal pretreatment improves degradation of lignin and hemicellulose and hence result in increased digestibility of cellulose, which is preferably essential for AD process. Several fungal classes, including brown-, white- and soft-rot fungi, have been used for pretreatment of lignocellulosic biomass for biogas production, with white-rot fungi being the most effective. Amirta et al. [78] employed four fungal species to pretreat Japanese cedar wood chips in the presence of wheat bran which supplements nutrition for fungal growth. They revealed that wood chips pretreated by Ceriporiopsis subvermispora ATCC 90467 produced the highest methane yield, which was 4 times higher than that of the control biomass at the end of 8 weeks.
\nSteam explosion pretreatment is an effort to expose the biomass to high temperature and pressure for short period of time and then reducing the pressure rapidly. This stops the reactions, causing the biomass to decompose explosively. This pretreatment condition may involve temperatures as high as 260°C and pressure up to 4.5 MPa. A study was investigated by Nges et al. [79] to improve the anaerobic biodegradability of Miscanthus lutarioriparius for biogas production. Employing steam explosion pretreatment with 0.3 M NaOH with particle size reduced to 0.5, they achieved a methane yield of 57% higher than that for the untreated samples. Their result was estimated to be 71% of theoretical methane yield of the biomass. Wang et al. [80] achieved a 24% higher methane yield than untreated bulrush at 1.72 MPa steam pressure, 8.14 min residence time, and 11% moisture content employing steam-explosion treatment of bulrush. During the pretreatment they observed the breakage, disruption, and redistribution of the rigid lignin structure which was proved by thermos gravimetric analysis. Srisang and Chavalparit [81] optimized a pre-treatment condition of 1.0% acetic acid, 17.45 min reaction time of sugarcane bagasse using steam explosion at 180° C. They achieved a maximum biogas production (434.47 L/kg VS) which was 91.88% higher than that of control (226.42 L/kg VS).
\nThe combination of thermal and chemical pre-treatments have been investigated in a number of studies in which the enhancement of the anaerobic digestibility of sludge was reported. Yi et al. [19] has used combined alkaline and low-temperature thermal pretreatment to enhance the subsequent AD of WAS. Different combinations of these two methods were investigated and biochemical methane potential (BMP) test was used to assess the anaerobic digestibility of pretreated WAS. With the combined treatment of adding 0.05 g NaOH/g TS and temperature maintained at 70°C for 9 h, they achieved a ratio of 72.8% soluble carbohydrate/total carbohydrate. Biogas production achieved through their BMP experiment was six times higher than the control and the average value of methane content of the produced biogas was 64%. In another study, Kavitha et al. [56], employed microwave irradiation to disintegrate the dairy WAS biomass after deagglomerating the sludge using a mechanical device, ultrasonicator. The outcomes of their study revealed that a higher biomass lysis efficiency of about 33.2% was possible through ultrasonic assisted microwave disintegration (UMWD) when compared to microwave disintegration MWD (20.9%). Their results of BMP test showed that UMWD has better amenability towards AD with 50% higher methane production representing enhanced liquefaction potential of disaggregated sludge biomass.
\nJang and Ahn [5] determined the effect of MW irradiation with NaOH pretreatment on AD of thickened municipal WAS in semi-continuous mesophilic digesters at HRT of 15, 10, 7, and 5 days. They combined MW pretreatment at temperature of 135°C with the input power of 1000 W with 60 ml of alkaline (20 meq NaOH/l) pretreated sludge. The degree of substrate solubilization arrived was 18 times higher in pretreated sludge (53.2%) than in raw sludge (3.0%). With HRT reduced to 5 days, they observed an improvement in biogas production (205% higher) for pretreated sludge compared with the control. The results show that MW irradiation combined with alkali pretreatment is effective in increasing mesophilic anaerobic biodegradability of sewage sludge. Ebenezer et al. [58] reported an increased COD and biopolymers release of WAS treated with Sodium citrate, a cationic binding agent, followed by microwaves pretreatment. They also concluded that the above pretreatment made the biomass more amenable for batch AD and hence higher biogas production with a methane content of 60–70% of biogas volume. Tamilarasan et al. [28] has made an attempt, by coupling a mechanical disperser with a chemical Sodium tripolyphosphate (STPP) for pretreatment of macro-algal biomass. They arrived at a 15% liquefaction and more than 5 times higher methane production compared to control at an optimal disperser-specific energy input of about 3312.67 kJ/kg TCOD (total COD) and an STPP dosage of about 0.04 g/g COD. Thus the combined pretreatment showed a greater biodegradability and biomethanation properties.
\nAmmonia fiber expansion is a promising method especially to pretreat agricultural materials for bioenergy production. Ammonia can be easily recovered and presents a high selectivity towards the lignin reactions, while preserving the carbohydrates. Ammonia can also penetrate the crystalline structure of cellulose and causes swelling [30]. The method involves treating the lignocellulosic biomass with liquid ammonia under mild temperature (70–200°C) and pressure (100–400 psi) for a specific time. This explosion results in several physical and chemical alterations in the structure of biomass. Jurado et al. [32] studied the effect of aqueous ammonia soaking (AAS) as a method to disrupt the lignocellulosic structure and increase the methane yield of wheat straw, miscanthus and willow. In all three cases, with AAS they observed an increase in methane yield from 37 to 41%, 25 to 27% and 94 to 162% for wheat straw, miscanthus and willow, respectively. Antonopoulou et al. [30] employed AAS as a pretreatment method, for the AD of three lignocellulosic biomass—poplar sawdust, sunflower straw and grass. In their study, they arrived at an increase in the ultimate methane yield being 148.7, 37.7 and 26.2% of poplar, sunflower straw and grass, respectively. They did not observe any toxic compounds such as furaldehydes, during AAS pretreatment.
\nIn this pretreatment, a very short burst (∼100 μs) of rapidly pulsed (several kHz), high voltage (about 20 kV) electric field is utilized to disrupt and break up the cell membrane of microorganism. This focused pulse (FP) induces a critical electrical potential across the cell membrane, causing cell lysis by direct attack on phospholipids and the peptidoglycan, respectively. Once the cell membranes get damaged, the intracellular organic material are released, making complex organic macromolecules more biodegradable [82]. They evaluated the effects of FP treatment and SRT on WAS in laboratory-scale digesters operated at SRTs of 2–20 days. They achieved an increased methane production rate and TCOD removal efficiency of about 33% and 18%, respectively, at a SRT of 20 days. They also concluded that, an increase in the hydrolysis rate was caused by FP-treatment of WAS, particularly at lower SRTs. Salerno et al. [83] applied FP to WAS and pig manure for increasing the production of methane during AD. In their work, methane production increased 200% for sludge and 80% for pig manure as compared to untreated sludge and manure. Thus PEF technology is advantageous due to low energy requirement for very short pulse time.
\nThe global energy supply is highly relying on fossil sources (crude oil, coal, natural gas) till now. According to the current energy policies and management, world market energy consumption is forecast to increase by 44% from 2006 to 2030 [84]. At the same time, concentrations of greenhouse gases in the atmosphere are rising rapidly, with fossil fuel-derived CO2 emissions being the most important contributor. Nowadays, increasing attention has been gained on various strategies for the bioconversion of biomass into methane-rich biogas, due to increased global warming, the need for sustainable waste management and high energy costs [41]. The production of biogas through AD offers significant advantages over other forms of bioenergy production. Unlike fossil fuels, biogas from AD is permanently renewable, as it is produced from biomass, which is a living form of storage of solar energy through photosynthesis [85]. It has been evaluated as one of the most energy-efficient and environmentally beneficial technology for bioenergy production [86]. It can drastically reduce GHG emissions compared to fossil fuels by utilization of locally available resources.
\nMany sources, such as crops, grasses, leaves, manure, fruit, and vegetable wastes or algae can be used, and the process can be applied in small and large scales in many parts of the world. Energy crops digestion requires prolonged HRT of several weeks to month to achieve complete fermentation with high gas yields and minimized residual gas potential of the digestate [4]. For an increased dissemination of biogas plants, further improvements of the process efficiency, and the development of new technologies for mixing, process monitoring, and process control are necessary. Pretreatment of substrates and the addition of micronutrients offers a major potential for increasing the biogas yield. With the increasing number of biogas plants, also an improvement of the effluent quality is necessary, in order to avoid a contamination of ground water with pathogens and nutrients [3]. The choice of a pretreatment should be made not only based on energy balance and economy, but also various environmental factors such as pathogen removal, use of chemicals, and the possibility for a sustainable use of the residues, impacts on human health and the environment [8]. Carballa et al. [87] evaluated the environmental aspects of different pretreatment methods in terms of abiotic resources depletion potential, eutrophication potential, global warming potential, human and terrestrial toxicity potential through a life cycle assessment.
\nThe profitable operation of a biogas plant relies on low capital and operational expenditures [28]. The frequent approaches including physical, thermal and chemical processes have been commercially implemented nowadays with a number of patented technologies. But research on biological techniques is still undergoing investigations from bench scale to full scale applications. Many pretreatment methods are expensive or have a high energy demand. The performance of any pretreatment method is quantified based on the economic feasibility of the method in terms of the cost of pretreatment versus the value of added methane yield. The effect of the pretreatment is however mostly dependent on the biomass composition and operating conditions. The investment costs for pretreatment of recalcitrant substrates are high at the moment due to high expenditure in process engineering. Biological disintegration is devoid of chemical contamination and energy inputs and the use of an enzyme secreting bacterial consortium for biomass is beneficial, as commercial enzymes are expensive [55]. But the need for long reaction times renders biological pretreatment unsuitable for large scale plants where land space is expensive or restricted.
\nMost studies reviewed assessed the impact of pretreatment processes on the biogas yield on a laboratory scale with a few determining the net energy gain/loss obtained after pretreatment [11, 28, 58]. Most studies in the literature are conducted as lab scale experiments and do not represent the same output that could be achieved through large scale biogas production facilities. Hence, there is a continuous need for newer and cleaner methods of biomass processing with less energy demand and lower waste generation.
\nThis chapter concludes the effect of various biomass pretreatment for enhancement of biogas production and the future challenges for an energy efficient and eco-friendly manner. Therefore, optimizing the pretreatment conditions in order to lower production costs, improving the process performance and production of fewer residues is needed. A pretreatment method optimized based on the above situations may enhance the performance of individual pretreatments and achieve technical, environmental and financial feasibility. However, a further research on combined pretreatments is necessary in the future to get useful information that may lead to the necessary improvements in the AD industry.
\nHistorically, cystic fibrosis (CF) caused fatal respiratory failure in early childhood [1, 2], but proactive multidisciplinary care has increased life expectancy to ~44 years [3]. With longer survival, co-morbidities have become more prevalent, the commonest being cystic fibrosis-related diabetes (CFRD) [4, 5]. This is associated with poorer clinical status [6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21], quality of life [22, 23], and life expectancy [16, 24, 25] relative to non-diabetic CF patients.
CFRD is distinct from other diabetes mellitus etiologies, including type 1 (T1D) and type 2 (T2D) (see Table 1) [4, 5]. It is caused primarily by chronic pancreatitis [26, 27, 28, 29, 30] with progressive insulin deficiency [9, 11, 31], particularly during first-phase insulin secretion [8, 9, 11, 19, 32, 33, 34, 35, 36, 37, 38, 39, 40]. Variations in peripheral insulin sensitivity also contribute to CFRD [20, 41]; hyperglycemia progressively induces insulin resistance via downregulation of glucose transporters [42, 43, 44], and insulin sensitivity decreases with inflammation, use of exogenous glucocorticoids, and puberty [45, 46, 47, 48, 49]. In CF, the depleted and dysfunctional pancreatic β-cells may be unable to compensate for this, producing early intermittent hyperglycemia progressing to fasting hyperglycemia [35, 44, 50].
Type 1 diabetes | Type 2 diabetes | CFRD | |
---|---|---|---|
Prevalence | 0.2% | 11% | 35% (likely underestimated due to lack of testing) |
Onset | Usually acute | Insidious | Insidious |
Peak age of onset | Childhood or adulthood | Adulthood | Ages 18–24 |
Usual body habitus | Normal | Overweight | Underweight, normal, or sometimes overweight (due to CF therapy success) |
Likely pathophysiology | β-cell dysfunction & destruction, primarily autoimmune with genetic & possible environmental causes | Peripheral insulin resistance & subsequent β-cell stress | β-cell destruction due to inspissated pancreatic secretions, inflammation, and replacement with fibrosis & amyloid, plus a component of β-cell dysfunction |
Insulin deficiency | Nearly complete | Partial and variable | Severe but not complete |
Insulin resistance | Variable | Severe | Variable depending on circumstances (e.g. glycemic control, pubertal stage, use of glucocorticoids, inflammation) |
Ketoacidosis risk | High | Low | Low |
Pharmacological & dietary therapy |
|
|
|
Complications | Microvascular & macrovascular disease | Microvascular & macrovascular disease |
|
Likeliest cause of death | Macrovascular disease | Macrovascular disease | CF pulmonary disease |
Comparison of common etiologies of diabetes. Adapted from Moran et al. [4].
CFRD is usually preceded by a spectrum of abnormal glucose tolerance (AGT) on oral glucose tolerance testing (OGTT), including impaired fasting glucose (IFG), indeterminate glucose tolerance (INDET), and impaired glucose tolerance (IGT) [4, 51]. There may be ‘waxing and waning’ of glucose tolerance between these categories [19, 52, 53, 54, 55], probably due to variations in insulin sensitivity [35, 44]. Nevertheless, large prospective cohort studies report overall deterioration in CF patients’ glucose tolerance over life [16, 20, 53, 54, 56]. The date of onset of CFRD is considered to be the first time a patient meets diagnostic criteria, even if glucose abnormalities subsequently resolve due to improvement in insulin sensitivity [4]. This is because studies utilizing this definition report correlations between CFRD duration, microvascular disease prevalence [57], and mortality [16, 56].
Taken together, these factors explain why CFRD becomes more common with age. Prevalence is ~1.5% in CF patients aged <10 years, but ~15% in those aged 11–17 and ~50% in those aged ≥18 [8, 16, 58]. The American Diabetes Association (ADA) recommends annual screening from age 10, using 2-h OGTT [59]. CFRD can also be diagnosed using clinical status, random blood glucose, fasting plasma glucose, and glycated hemoglobin (HbA1c) [4, 60, 61]. In clinically-stable outpatients with CF, diagnostic criteria are identical to those used for other etiologies of diabetes mellitus [4], and are shown in Table 2. Recently, continuous glucose monitoring (CGM) has also been used to investigate glucose abnormalities in CF patients. This method is not yet widely recommended for diagnosis of diabetes, but it is often used to monitor glycemic control or assist insulin dosage [62]. Moreover, CGM often detects even earlier CF-related glucose abnormalities than OGTT, in the form of intermittent postprandial glucose excursions [63].
Glucose measurement method | Diagnostic criteria | ||
---|---|---|---|
Normal ranges | Pre-diabetic ranges | Diabetic ranges | |
Clinical status | Classical symptoms of hyperglycemia, including polyuria, polydipsia, and hyperglycemic crisis, may assist diagnosis of diabetes when combined with other positive diagnostic tests. Some CF-specific definitions also consider unexplained decline in lung function & nutritional status to be classical symptoms. | ||
HbA1c | ≤5.6% (38 mmol/mol) | 5.7–6.4% (39–46 mmol/mol) | ≥6.5% (48 mmol/mol) |
Random blood glucose | — | — | ≥11.1 mmol/L (200 mg/dL) |
Fasting plasma glucose | <5.6 mmol/L (100 mg/dL) | IFG: ≥5.6 mmol/L (100 mg/dL), <7.0 mmol/L (126 mg/dL) | ≥7.0 mmol/L (126 mg/dL) |
2-h OGTT | 0 min: <5.6 mmol/L (100 mg/dL) 2 h: <7.8 mmol/L (140 mg/dL) | All categories constitute AGT IFG: 0 min: ≥5.6 mmol/L (100 mg/dL), <7.0 mmol/L (126 mg/dL) 2 h: N/A INDET: 0 min: <7.0 mmol/L (126 mg/dL) OGTT midpoints: ≥11.1 mmol/L (200 mg/dL) 2 h: <7.8 mmol/L (140 mg/dL) IGT: 0 min: <7.0 mmol/L (126 mg/dL) 2 h: ≥7.8 mmol/L (140 mg/dL), <11.1 mmol/L (200 mg/dL) | 0 min: ≥7.0 mmol/L (126 mg/dL) AND/OR 2 h: ≥11.1 mmol/L (200 mg/dL) |
CGM | Usually <7.8 mmol/L (140 mg/dL) | Elevations ≥7.8 mmol/L (140 mg/dL) are referred to as glucose excursions, but there are no standardized criteria correlating them with AGT or diabetes. |
Diagnostic criteria of glucose measurement methods commonly used in CF. Diagnosis must occur during clinical stability, defined as no pulmonary exacerbations during the past 6 weeks and no current systemic glucocorticoids. It is also recommended that any positive fasting plasma glucose, HbA1c, or OGTT is repeated at a later date. Non-CGM diagnostic criteria are from the American Diabetes Association [59, 64]. CGM diagnostic criteria are from the Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group [65].
HbA1c = glycated hemoglobin. OGTT = oral glucose tolerance testing. IFG = impaired fasting glucose. AGT = abnormal glucose tolerance. INDET = indeterminate glucose tolerance. IGT = impaired glucose tolerance. CGM = continuous glucose monitoring.
This chapter compiles research on use of each glucose measurement method in CF patients, with special focus on pre-diabetic patients. The benefits and limitations of each method will be explored to help ascertain when their usage might be appropriate. In the process, we will examine correlations between early glucose abnormalities and clinical decline. Finally, we will review preliminary evidence of improved long-term outcomes with insulin treatment of early glucose abnormalities, supporting their detection and management in routine practice.
The ADA allows diagnosis of CFRD following one random blood glucose measurement ≥11.1 mmol/L, provided that it is combined with polyuria, polydipsia, or hyperglycemic crisis [59]. However, symptomatic hyperglycemia or hyperglycemic crisis is extremely rare in CFRD [4]. In Lanng et al.’s seminal 5-year prospective cohort study of 191 CF patients receiving annual OGTT, only 33% of those diagnosed with CFRD had polyuria or polydipsia [54]. Moreover, in a cross-sectional study of all 60 patients aged ≥10 years at a Brazilian CF center, age at diagnosis was significantly lower for patients diagnosed using OGTT as opposed to clinical criteria (13.5 years vs. 22.3 years), implying much earlier detection of disease [66].
Some centers compensate by accepting unexplained decline in lung function or nutritional status as classical symptoms of hyperglycemia (see Section 3) [67]. In one cross-sectional study of 91 CF patients not known to be diabetic, these modified clinical criteria detected OGTT-diagnosed CFRD with 58% sensitivity [68], which is an improvement over other studies but still suboptimal for a screening test.
HbA1c, i.e. glycated hemoglobin as a percentage of total hemoglobin, is commonly used to monitor glycemic control in diabetes mellitus. It usually reflects average blood glucose over the life of an erythrocyte (~3 months) [64, 69]. However, CF patients with CFRD, INDET or IGT rarely have a significantly-higher HbA1c than those with normal glucose tolerance (NGT) [11, 70, 71, 72, 73], and even statistically-significant differences tend to be of <1% magnitude [8, 34, 40, 74, 75]. Godbout et al.’s study of 13 CFRD patients also found that HbA1c did not correlate with mean plasma glucose, as calculated using fingerprick self-monitoring [76].
Numerous hypotheses have been espoused to explain HbA1c’s relatively poor correlation with glucose tolerance in CF. These include insufficient duration of transient CF-related post-prandial hyperglycemia, which is often limited to the early phase of insulin secretion; alteration of hemoglobin glycation by hypoxia; iron deficiency, which is a common comorbidity of CF; and increased erythrocyte turnover in the context of chronic inflammation [1, 4, 5, 76, 77]. This implies that HbA1c may vary with degree of inflammation [78], and that trends in HbA1c may be more useful for predicting deterioration in glucose tolerance. Supporting this, Lanng et al.’s 5-year prospective cohort study found significant differences in median HbA1c between patients who consistently had NGT (5.2%), patients who varied between NGT and IGT (5.3%), patients who developed CFRD during the study (5.8%), and patients who entered the study with a diagnosis of CFRD (6.5%) [54].
It has also been hypothesized that poor correlation between mean plasma glucose and HbA1c may be confounded by use of fingerprick tests to measure glucose, since these can easily miss CF-related hyperglycaemic peaks due to their relative infrequency [76]. In two studies of CF and CFRD patients, mean plasma glucose was estimated using 2–7 days of CGM rather than fingerprick self-monitoring, and strongly correlated with HbA1c (r = 0.86–0.89) [75, 79].
These findings have regenerated interest in potentially using HbA1c to screen for CF-related glucose abnormalities, especially because it is much more convenient than OGTT. However, computing HbA1c thresholds suitable for CFRD screening has proved challenging. Some studies do report almost 100% sensitivity for OGTT-defined CFRD using HbA1c thresholds of 6.0–7.5% [40, 80, 81, 82], but all have small sample sizes, and most either did not calculate sensitivity to CF-related AGT [81] or report low values, ~20–50% [80, 82]. Therefore, HbA1c may not detect CFRD and its complications until late. Moreover, most evidence suggests that the diagnostic threshold for CFRD, HbA1c ≥6.5%, has poor sensitivity compared to OGTT [54, 83, 84, 85].
Lowering the diagnostic threshold for HbA1c abnormalities does increase sensitivity to both CFRD and AGT, but the thresholds required to achieve sufficient sensitivity for screening generally have unacceptably low specificity [60]. There is also wide variation in the sensitivities and specificities reported by different studies using the same HbA1c threshold; this may be due to differences in type of HbA1c assay [74, 86] and timing of the studies relative to the institution’s routine OGTT screening [87]. Yung et al., conducting a cross-sectional study of 91 CF patients not known to be diabetic, but also not previously routinely screened, found that HbA1c ≥6.1% had 83% sensitivity for OGTT-diagnosed CFRD [68]. However, more recent studies with similar designs report only 30–50% sensitivity [39, 82, 88, 89].
Given this uncertainty, the current advice from the ADA is that HbA1c should not be used to screen for CF-related glucose abnormalities [59]. HbA1c is still recommended for monitoring glycemic control in CFRD, although normal results must be interpreted with caution [4, 78]. It has also been suggested that HbA1c might be a useful adjunct to OGTT in screening, as its results may fluctuate less and hence, may more accurately predict long-term risk of glucose abnormalities. In a recent 6-year retrospective cohort study of 50 NGT adults with CF followed up with annual OGTT, HbA1c ≥5.6% had OR 3.49 for development of IGT or CFRD [90].
In 2003, the ADA briefly sanctioned fasting plasma glucose as an alternative to OGTT in CFRD screening, because there were insufficient data supporting insulin therapy for CFRD without fasting hyperglycemia [91]. However, subsequent studies have demonstrated similar insulin-induced clinical improvements in patients with and without fasting hyperglycemia [16, 92], and treatment of CFRD without fasting hyperglycemia is now standard practice [4]. Only 16–25% of patients diagnosed with CFRD on OGTT have fasting hyperglycemia [8, 54, 68, 81].
Use of fasting glucose to detect pre-diabetic stages on the glucose tolerance spectrum remains somewhat contentious in CF. Most studies report that fasting plasma glucose does not significantly differ between CF patients with NGT, INDET or IGT [39, 72, 93]. The ADA does use fasting glucose to define one pre-diabetic glucose tolerance category, IFG (5.6–6.9 mmol/L), and suggested in 2003 that screening OGTTs could be limited to IFG patients [94]. A prospective cohort study of 1128 CF patients aged 10–64 found that this approach would reduce number of OGTTs by 67%, but miss 17.8% of CFRD and IGT [94]. In a cross-sectional analysis of 73 children with CF, IFG had 100% sensitivity for CFRD, but only 25% sensitivity for IGT [11].
Finally, like HbA1c, there is debate regarding the utility of IFG as an adjunctive test for predicting long-term risk of CFRD. Frohnert et al. found no significant relationship [95], but Schmid et al. found that IFG generated OR 2.72 for CFRD [96].
As discussed above, other conventional diagnostic tests have <100% sensitivity for CFRD compared to OGTT. Therefore, OGTT remains the recommended screening test in CF. It is also the only test with standardized definitions of multiple pre-diabetic glucose abnormalities, all demonstrated to predict development of CFRD [96].
Nevertheless, there are several issues with the 2-h OGTT. It may be more inconvenient and resource-intensive than other glucose measurement methods, which is of particular concern in CF because patients and clinics already face a high treatment burden from other aspects of CF care [97]. It also requires patient co-operation, which can be difficult when assessing children [93]. Patients are expected to consume at least 150 g (600 kcal) of carbohydrates for 3 days before an OGTT, then fast for 8 h overnight and be tested early the next morning [59]. They must drink a solution containing a 1.75 g/kg glucose load, preferably within 5 min, then lie or sit quietly for 2 h [64]. In a standard OGTT, venous blood is sampled twice: immediately before ingestion of the load, and at 120 min (BG120). Many CF centers also take hourly or 30-minutely samples to detect post-prandial hyperglycemia that resolves before 2 h [59]. As described earlier, these transient post-prandial glucose excursions are very common in CF, due to selective impairment of early insulin secretion. Our group previously performed OGTT with 30-minutely sampling in 33 children with CF aged 10–19, and found that peak venous insulin concentration was delayed until 90–120 min, producing an early venous glucose peak at 60–90 min [9] (Figure 1).
Venous blood glucose (□) and insulin ( ▓ ) in 30-minutely samples over a 2-h oral glucose tolerance test, as measured in 33 children with CF aged 10–19. Boxes indicate interquartile range, horizontal lines indicate median, whiskers indicate 5th and 95th percentiles. Figure taken from Hameed et al. [9].
The inconvenience of OGTT may contribute to poor patient uptake of CFRD screening [98, 99, 100]. In 2018, the Cystic Fibrosis Foundation Patient Registry reported that the average CF center was screening just 61.3% of adolescents and 32.8% of adults [100]. Rates of utilization of other glucose measurement methods, such as HbA1c and fasting glucose, were much higher (92.3% for adolescents and 89.6% for adults), suggesting that the main barrier to screening is the OGTT itself [100]. Suggested solutions include shortening the OGTT to 60 or 90 min [83] or replacing it with the 50-g non-fasting 1-h glucose challenge test [89, 101], which is currently used to screen for gestational diabetes mellitus in healthy women [101]. These modified OGTT protocols are not standard recommended practice [4].
There are also other issues with the OGTT that likely cannot be resolved by simply shortening it. Its diagnostic thresholds are not specific to CF and may be insensitive to CF-related clinical decline (see Section 3). OGTT results also frequently fluctuate in CF, with a large multicenter prospective cohort study finding a variability coefficient 1.5–1.8 times higher than in the general population [55]. Similarly, in two 4–5 year prospective cohort studies, 18–58% of AGT patients demonstrated overall improvement in glucose tolerance category, while only 14–22% demonstrated deterioration [19, 54].
Finally, even with venous sampling at additional timepoints, the peak blood glucose measurements recorded during OGTT may poorly reflect peak blood glucose achieved by CF patients in daily life [4, 60, 61]. After all, the OGTT’s 1.75 g/kg load contains less glucose than most CF patients’ everyday meals [61, 98]. This has prompted research into CF-related glucose abnormalities using CGM, a technology that can screen for glucose excursions over a longer interval of everyday life and high calorie CF diet.
Most CGM systems consist of two parts: a sterile sensor, worn subcutaneously for up to 14 days, and a transmitter attached to the sensor that measures interstitial fluid glucose every 30 s, recording an average every 5 min [97] (Figure 2). Some systems do not require a separate sensor, instead measuring interstitial fluid glucose via an electrical current applied across intact skin, but issues have been reported with skin reactions and inaccuracy [102]. Interstitial fluid glucose reflects capillary glucose with a 4–20 min delay [103].
Continuous glucose monitor sensor, before and after attachment of the transmitter. ‘CGM set’ and ‘Continuous Glucose Monitor’ by Sara Bassett are licensed under CC BY-NC-SA 2.0.
CGM has been validated against OGTT in children with CF of all glucose tolerance categories [104] and non-diabetic adolescents and adults with CF [105]. A subsequent study of this latter group found that they differed significantly from healthy controls in mean CGM glucose (+14.1%) and presence of CGM peaks ≥11.1 mmol/L (+33%), but not in the conventional diagnostic measures of fasting glucose, BG120, and HbA1c [106]. Moreover, 70% of CF patients undertaking simultaneous CGM and OGTT had their CGM peak outside OGTT [106]. This was the beginning of a substantial body of evidence demonstrating the superior sensitivity of CGM to CF-related glucose excursions above OGTT diagnostic thresholds, with numerous studies finding CGM glucose peaks ≥7.8 or 11.1 mmol/L in 71–93% of patients classified as NGT on recent OGTT [14, 31, 85, 98, 107, 108]. In a 5-year prospective cohort study of 21 adults with CF, 83% had their CGM peak and BG120 fall in different diagnostic categories, and for 93% the CGM-identified category was worse. Again, this suggests the superior sensitivity of CGM over OGTT [98].
Most of this evidence, particularly in children, is limited by small sample sizes [14, 85, 98, 107, 108] and lack of non-CF controls [14, 85, 98, 108]. However, it is logical that the increased duration and frequency of glucose monitoring facilitated by CGM, and the opportunity to incorporate the patient’s usual diet and physical activity, facilitates more sensitive detection of glucose excursions [109]. CGM is also generally easier and better tolerated than OGTT [78]. While sensors and transmitters are expensive, and staff do require training on their usage, they have become more user-friendly, smaller and cheaper over time [73, 110]. The newest devices can be inserted rapidly during a clinic appointment, do not require calibration against fingerpricks, and can be removed by patients or carers without medical supervision [97].
CGM does have one major disadvantage compared to OGTT. The clinical significance of the mild glucose excursions that it detects are still being determined; consequently, there is no standardized system for recognizing and describing clinically relevant CGM findings, and no universally accepted threshold for initiation of treatment [97]. Common variables computed by CGM software include average sensor glucose, maximum glucose, area under the curve of glucose per day (AUCglucose/day), percentage time spent above thresholds (e.g. 7.8 or 11.1 mmol/L), number of excursions ≥11.1 mmol/L, and measures of glycemic variability, such as standard deviation of average sensor glucose [103]. All these parameters have been correlated with HbA1c in CF patients [75], and many have been correlated with clinical outcomes. However, these studies report heterogeneous findings and rarely include substantial prospective follow-up (see Section 3) [84].
Given all these factors, CGM is not yet widely recommended for CFRD diagnosis or screening [4]. However, it is used in some centers for diagnosis and screening, follow-up of borderline diagnostic tests, and investigation of patients who cannot or refuse to undergo OGTT [31, 111, 112]. Like HbA1c, it may also be useful as an adjunctive test for predicting long-term risk of CF-related glucose abnormalities. In a prospective cohort study of 17 children with CF, all those who had glucose excursions ≥11.1 mmol/L on CGM developed either CFRD or IGT with INDET over a period of 2.5 years, irrespective of their glucose tolerance at baseline [107].
CFRD is well-understood to have a differing profile of sequelae as compared to T1D or T2D. Macrovascular disease is uncommon outside of case reports [1, 4, 5, 113], and although screening for microvascular disease should be routinely undertaken [59], microvascular complications are uncommon until at least 5–10 years of CFRD with fasting hyperglycemia [57, 114, 115]. Therefore they are substantially predated by declines in lung function [6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 116, 117, 118] and nutritional status [7, 9, 10, 11, 12, 14, 117], both of which are significant predictors of early mortality in CF [10, 11, 16, 18, 25, 56, 119]. Four large cohort studies also report higher annual frequency in diabetic vs. non-diabetic CF patients of pulmonary exacerbations requiring intravenous antibiotics or hospitalization [10, 21, 39, 120], and it was recently demonstrated that diabetic CF patients have reduced recovery of baseline forced expiratory volume in 1 sec as a percentage of predicted (FEV1%) following pulmonary exacerbations [116].
A causative relationship between CFRD, impaired lung function, and poor nutritional status is implied by the clinical improvements seen following insulin therapy [13, 92, 120, 121, 122], and is also biologically plausible on several accounts. Insulin is a powerfully anabolic hormone, therefore insulin deficiency combined with CF’s increased metabolic requirements promotes catabolism with nutritional decline [9, 93, 123, 124]. Regarding lung function and pulmonary exacerbations, hyperglycemia is known to promote respiratory tract infections (RTIs) both systemically, via pro-inflammatory and immunosuppressive effects [125, 126], and locally, via glucose leakage into airway secretions, which could promote pathogen growth [125, 127, 128, 129, 130]. Several cohort studies report higher prevalence in diabetic vs. non-diabetic CF patients of certain RTIs, including Pseudomonas aeruginosa [10, 19, 117, 131], Staphylococcus aureus [132, 133], and Burkholderia cepacia [10, 117, 132].
Finally, hyperglycemia can also impair lung function through non-infective pathways. It has been associated with restrictive lung disease in T1D and T2D (via non-enzymatic glycation of collagen and elastin) [134], and with inflammatory and proteolytic lung destruction in CFRD [135, 136, 137]. Lung proteolysis may be exacerbated by protein catabolism [19, 122], which can furthermore weaken respiratory muscles [138, 139] and impair immunoprotein synthesis during RTIs [61]. This may explain why lung function in CF also correlates with nutritional status [6, 7, 140, 141, 142].
Numerous cohort and case-control studies examining the 1–5 years before CFRD diagnosis report decline in lung function [19, 35, 38, 92, 143, 144, 145, 146] and nutritional status [19, 35, 38, 92, 143, 144] in pre-diabetic patients, or significantly reduced values compared to non-diabetic CF controls [12, 17]. This suggests that pre-diabetic glucose abnormalities are clinically significant. Two case-control studies focusing specifically on pediatric populations also report that pre-diabetic children with CF have significantly lower height and weight velocities than non-diabetic CF controls [145, 146], with one study demonstrating differences up to 11 years before CFRD diagnosis [146]. These differing velocities produce steadily-widening gaps in height-for-age and weight-for-age, reaching statistically-significant sizes after CFRD diagnosis, usually around ages 15–19 [18, 146]. Importantly, this growing disparity seems to occur even if aggressive insulin therapy is commenced at diagnosis [144], and although it may narrow with prolonged therapy, it may not fully correct [18, 144, 147]. Therefore, optimizing clinical outcomes in CFRD may require treatment of pre-diabetic abnormalities, highlighting the importance of glucose measurement systems that can sensitively predict clinical decline.
Traditional OGTT diagnostic thresholds are not specific to CF – in fact, they were originally designed to predict T2D-associated microvascular disease in Pima Native Americans [148]. This may explain their apparent insensitivity to CF clinical outcomes. A few studies do report poorer lung function or nutritional status in IGT vs. NGT CF patients [37, 72], and several more identify IGT as a significant risk factor for substantial decline in FEV1% over 4–5 years [19, 149]. However, most studies attempting to correlate IGT with contemporary lung function and nutritional status find no significant relationship [19, 33, 34, 39, 53, 70, 71, 72, 73, 150, 151, 152].
A more successful non-conventional OGTT parameter is the additional glucose tolerance category of INDET, defined as blood glucose ≥11.1 mmol/L at an OGTT midpoint – most commonly 60 min (BG60) – as opposed to 0 or 120 min [4]. BG60 has been shown to inversely correlate with BMI in children with CF, and correlates with FEV1% and forced vital capacity as a percentage of predicted (FVC%) in both children [7] and adults [150]. In a subsequent study, INDET patients had mean FEV1% comparable to CFRD patients, representing a significant reduction compared to NGT and IGT patients [71]. INDET has also been confirmed to predict development of CFRD (OR 2.81 over ~3.5 years) [93, 96].
Other OGTT parameters shown to predict FEV1% in non-diabetic CF patients include higher peak glucose (BGmax) [9, 33, 72, 153], higher AUCglucose [124, 153], and reduced insulin secretion [34, 35, 72, 124]. Finally, a few studies have correlated FEV1% with trajectories of deterioration in glucose tolerance [41, 154]. One prospective cohort study recruited 152 non-diabetic CF patients, and stratified them according to whether their glucose tolerance on OGTT improved, deteriorated or remained stable over 2 years [41]. While all patients experienced a decline in FEV1%, the extent of decline only reached statistical significance in patients of stable or deteriorating glucose tolerance, and those of deteriorating glucose tolerance also had a much larger drop than those of stable glucose tolerance (−6.1% vs. −1.6%) [41].
It is rarer for studies to report correlations between OGTT parameters and nutritional status [33, 34, 35, 41, 71, 72, 154], possibly because intensive dietician management of CF mitigates nutritional decline [133, 154]. Nevertheless, one seminal prospective cohort study inversely correlated age-adjusted height and BMI with AUCglucose [8], and a recent cross-sectional study found that lower-than-median insulin secretion at 60 min is independently associated with worse BMI [150]. In children, BMI (calculated as weight in kg divided by the square of height in meters) may be a less sensitive measure of nutritional status than weight-for-age, as poor linear growth may mask decline [146]. Nevertheless, Wooldridge et al. report a direct correlation between AUCinsulin and BMI z-score in 146 NGT children with CF aged 5–20 [123], and our group has found that AUCglucose inversely correlates with age-adjusted weight, height and BMI in children aged ≤10 years [153]. Furthermore, in an earlier cohort study of 33 children aged 10–19, we found that higher BGmax was associated with decline in weight z-score, FEV1% and FVC% over the past 12 months, and BGmax ≥8.2 mmol/L had 87% sensitivity and 70% specificity for a clinically significant decline in weight z-score [9]. By contrast, BG120 was no better than chance at detecting decline in weight z-score, and the conventional diagnostic threshold of 11.1 mmol/L had only 10% sensitivity [9]. These findings led us to propose an alternative system for classifying CF-related glucose abnormalities on OGTT, the Cystic Fibrosis Insulin Deficiency (CFID) stages (Table 3) [9].
Diagnostic category | o-min OGTT glucose | Max OGTT glucose | 2-h OGTT glucose |
---|---|---|---|
CFID1 | <7.0 mmol/L | ≥8.2 mmol/L | <11.1 mmol/L |
CFID2 | <7.0 mmol/L | ≥11.1 mmol/L | <11.1 mmol/L |
CFID3 | <7.0 mmol/L | N/A | ≥11.1 mmol/L |
CFID4 | ≥7.0 mmol/L | N/A | N/A |
Cystic fibrosis insulin deficiency (CFID) classification system of CF-related glucose abnormalities, as proposed by Hameed et al. [9].
Six main studies have explored the clinical significance of CGM-based measures of CF-related early glucose abnormalities [9, 98, 111, 152, 155, 156]. Their results are compelling but heterogeneous. Taylor-Cousar et al. conducted a 5-year prospective cohort study of 17 originally non-diabetic CF patients, 7 of whom developed CFRD during observation [98]. In this subgroup, there was significant inverse correlation between peak glucose and BMI, and a trend towards correlation with FEV1% [98]. Leclercq et al. also examined peak glucose, stratifying 38 NGT CF patients according to whether they had any peaks ≥11.1 mmol/L during 72-h CGM [155]. In the ‘yes’ group, there was significantly lower FEV1% and FVC%, and increased risk of colonization with P. aeruginosa [155].
In the aforementioned study undertaken by our research group in 33 children with CF aged 10–19, we also showed that percentage time ≥7.8 mmol/L on CGM predicted 12-month rate of decline in weight z-score, FVC%, and FEV1%. Similarly, on receiver operator characteristic (ROC) analysis, ≥4.5% time at ≥7.8 mmol/L on CGM was a sensitive and specific predictor of clinically significant decline in weight z-score and FVC% [9]. Frost et al. subsequently used these parameters to interpret the CGM results of 59 adults being investigated for CF-related glucose abnormalities [112]. They found that percentage time ≥7.8 mmol/L on CGM correlated with baseline FEV1% and 12-month rate of decline [112].
In Chan et al.’s study of 88 children with CF aged 10–18, 12-month decline in FEV1% and FVC% was predicted by multiple other CGM parameters: peak glucose, number of daily glucose excursions >11.1 mmol/L, mean amplitude of glycemic excursions, and standard deviation [152]. Brugha et al. investigated another glycemic variability measure, glucose interquartile ranges, in a 7-year retrospective cohort study [111]. On ROC analysis, ranges >1.95 mmol/L predicted CFRD with 60% sensitivity and 98% specificity, but did not correlate with BMI or FEV1% [111].
Finally, our group recently conducted a cross-sectional study of 18 children with CF aged ≤5 years [156]. Even in this very young group, history of P. aeruginosa was predicted by mean glucose and percentage time at ≥7.8 mmol/L, and levels of inflammatory markers in bronchoalveolar lavage fluid were predicted by peak glucose, mean glucose, percentage time at ≥7.8 mmol/L, and standard deviation [156].
Three studies report a weak inverse correlation between HbA1c and lung function in non-diabetic CF patients (r = −0.25–0.3) [72, 73, 88], and one of these also found a direct correlation with number of infective pulmonary exacerbations per year [73]. In two more studies, HbA1c ≥ 5.5–5.8% predicted poorer FVC% [74] or FEV1% [82]. Therefore HbA1c, despite its insensitivity to CF-related glucose abnormalities, may be a useful harbinger of clinical decline when elevated.
Several studies have also investigated fructosamine, glycated albumin, and 1,5-anhydroglucitol as alternatives to HbA1c in CF. These biomarkers are not dependent on the lifespan of erythrocytes, and have been shown to correlate with mean plasma glucose in CF as estimated using CGM [75]. However, evidence of their ability to predict glucose abnormalities and clinical decline in CF is currently mixed [11, 74, 157]. In one study, fractional serum fructosamine (FSF) ≥3.70 μmol/g predicted IGT and CFRD with 100% sensitivity and 67% specificity, and patients with elevated FSF also had significantly lower median FEV1% (47% vs. 90%) [157].
Early evidence suggests that fasting glucose, including IFG, does not correlate with clinical status in CF [53, 95]. In one case-control study, IFG actually predicted better lung function than normal fasting glucose in some patient subgroups, particularly children with simultaneous IGT [95]. It was hypothesized that IFG may represent a physiological adaptation to CF, with hepatic glucose production upregulated to meet increased baseline metabolic requirements [95].
Our institute, the Sydney Children’s Hospital, provides one example of integrating multiple glucose measurement methods into routine practice. Children with CF are screened annually for glucose abnormalities from age 10, using OGTT with 30-minutely sampling. CGM is used to follow up borderline OGTTs, or to investigate children with clinically-suspected glucose abnormalities who have normal OGTTs or are unable to undergo OGTT. CGM excursions ≥11.1 mmol/L over 72 h of monitoring are considered severe abnormalities that warrant further investigation for possible insulin therapy. Moreover, some pre-diabetic children on OGTT are randomized to insulin therapy via the CF-IDEA trial (
Ultimately, the most clinically relevant measures of CF-related early glucose abnormalities are those that alter patient management. Therefore the long-term effects of actively treating early abnormalities is an important research question. Most studies have focused on insulin therapy, as insulin is currently the only recommended pharmacotherapy for CFRD (in part because of its anabolic effects) [59]. Emerging research has also explored oral anti-hypoglycemics [158], incretin modifiers [159], and CFTR modulators [160, 161].
It is already known that earlier diagnosis and treatment of CFRD, via OGTT screening programs, improves life expectancy and resolves historical sex differences in clinical outcomes (females with CFRD previously did worse than males) [16, 24]. Seven studies were identified trialing insulin therapy for CF patients who were pre-diabetic on OGTT [92, 122, 143, 162, 163, 164]. Five report statistically-significant improvements in lung function [122, 163, 165], nutritional status [122, 143, 164, 165], or rate of decline in either variable [163, 164], either intra-individually or relative to untreated controls. Moreover, five out of six studies assessing tolerability found no significantly-increased incidence of symptomatic hypoglycemia [92, 122, 143, 162, 164, 165]. Finally, one additional study has assessed the efficacy of insulin therapy initiated based on CGM, via retrospective analysis of all non-diabetic adults at a British CF center who had a CGM ordered between 2013 and 2016 [112]. Insulin was initiated if patients spent >4.5% time at >7.8 mmol/L on CGM, and if they recorded no clear triggers for these glucose excursions in a contemporary food diary. Patients treated with insulin demonstrated statistically-significant improvements in FEV1% and weight within 3 months of treatment, and maintained an improvement in weight and annual rate of lung function decline at 12 months [112].
All this suggests that treatment of CF-related AGT may be beneficial. However, results are difficult to generalize, due to heterogeneity in studies’ inclusions criteria, types of controls, and insulin regimens [166]. Studies are also limited by small sample sizes [92, 112, 122, 143, 162, 163, 164, 165], short durations [92, 112, 122, 143, 162, 165], and mixed analysis of pre-diabetic and diabetic patients [92, 122], highlighting the need for large long-term randomized control trials. One such trial, CF-IDEA (
As patients with CF live longer, CFRD becomes an increasingly prevalent serious co-morbidity, associated with significant decline in lung function and nutritional status. Evidence suggests that this decline may begin years earlier, in the pre-diabetic phase. Currently, OGTT is the most sensitive licensed diagnostic tool for identifying pre-diabetic CF-related glucose abnormalities, but its utility is limited by inconvenience, high variability of results, and insensitivity of traditional diagnostic categories to CF-related glucose excursions and clinical decline. Development of standardized interpretation systems for CGM may revolutionize detection of clinically relevant early glucose abnormalities. Results of randomized controlled trials of insulin treatment prior to onset of CFRD may alter the point at which insulin is offered.
SH, AJ and CFV have received funding from the National Health and Medical Research Council of Australia, Australasian Cystic Fibrosis Research Trust, Regional Diabetes Support Scheme, Sydney Children’s Hospital Foundation, and Australasian Pediatric Endocrine Care Grant from Pfizer, and industry support from Novo Nordisk, Medtronic, and Abbott Diagnostics. BP has been awarded a fellowship from the Thoracic Society of Australia and New Zealand and Vertex, and a postgraduate scholarship from the National Health and Medical Research Council of Australia.
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\\n\\nThe same principles apply to Works published under the CC BY-NC-SA 3.0 license, with the caveats that (1) the content may not be used for commercial purposes, and (2) derivative works building on this content must be distributed under the same license. The restrictions contained in these license terms may, however, be waived by the copyright holder(s). Users wishing to circumvent any of the license terms are required to obtain explicit permission to do so from the copyright holder(s).
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\\n\\nAll rights to Books and all other compilations published on the IntechOpen platform and in print are reserved by IntechOpen.
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\\n"}]'},components:[{type:"htmlEditorComponent",content:'Copyright is the term used to describe the rights related to the publication and distribution of original Works. Most importantly from a publisher's perspective, copyright governs how Authors, publishers and the general public can use, publish, and distribute publications.
\n\nIntechOpen only publishes manuscripts for which it has publishing rights. This is governed by a publication agreement between the Author and IntechOpen. This agreement is accepted by the Author when the manuscript is submitted and deals with both the rights of the publisher and Author, as well as any obligations concerning a particular manuscript. However, in accepting this agreement, Authors continue to retain significant rights to use and share their publications.
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\n\nWork - a Chapter, including Conference Papers, and any and all text, graphics, images and/or other materials forming part of or accompanying the Chapter/Conference Paper.
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LICENSE | \n\t\t\tUSED FROM - | \n\t\t\tUP TO - | \n\t\t
\n\t\t\t Creative Commons Attribution-NonCommercial-ShareAlike 3.0 Unported (CC BY-NC-SA 3.0) \n\t\t\t | \n\t\t\t\n\t\t\t 1 July 2005 (2005-07-01) \n\t\t\t | \n\t\t\t\n\t\t\t 3 October 2011 (2011-10-03) \n\t\t\t | \n\t\t
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The CC BY 3.0 license permits Works to be freely shared in any medium or format, as well as the reuse and adaptation of the original contents of Works (e.g. figures and tables created by the Authors), as long as the source Work is cited and its Authors are acknowledged in the following manner:
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\n\nRepublishing – More about Attribution Policy can be found here.
\n\nThe same principles apply to Works published under the CC BY-NC-SA 3.0 license, with the caveats that (1) the content may not be used for commercial purposes, and (2) derivative works building on this content must be distributed under the same license. The restrictions contained in these license terms may, however, be waived by the copyright holder(s). Users wishing to circumvent any of the license terms are required to obtain explicit permission to do so from the copyright holder(s).
\n\nDISCLAIMER: Neither the CC BY 3.0 license, nor any other license IntechOpen currently uses or has used before, applies to figures and tables reproduced from other works, as they may be subject to different terms of reuse. In such cases, if the copyright holder is not noted in the source of a figure or table, it is the responsibility of the User to investigate and determine the exact copyright status of any information utilised. Users requiring assistance in that regard are welcome to send an inquiry to permissions@intechopen.com.
\n\nAll rights to Books and all other compilations published on the IntechOpen platform and in print are reserved by IntechOpen.
\n\nThe copyright to Books and other compilations is subject to separate copyright from those that exist in the included Works.
\n\nAll Long Form Monographs/Compacts are licensed under the Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) license granted to all others.
\n\nCopyright to the individual Works (Chapters) belongs to their specific Authors, subject to an agreement with IntechOpen and the Creative Common license granted to all others to:
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\n\nAll Book cover design elements, as well as Video image graphics are subject to copyright by IntechOpen.
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\n\nAll Video Lectures under IntechOpen's production are subject to copyright and are property of IntechOpen, unless defined otherwise, and are licensed under the Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) license. This grants all others the right to:
\n\nShare — copy and redistribute the material in any medium or format
\n\nUnder the following terms:
\n\nUsers wishing to repost and share the Video Lectures are welcome to do so as long as they acknowledge the source in the following manner:
\n\n© {year} IntechOpen. Published under CC BY-NC-ND 4.0 license. Available from: {DOI}
\n\nUsers wishing to reuse, modify, or adapt the Video Lectures in a way not permitted by the license are welcome to contact us at permissions@intechopen.com to discuss waiving particular license terms.
\n\nAll software used on the IntechOpen platform, any used during the publishing process, and the copyright in the code constituting such software, is the property of IntechOpen or its software suppliers. As such, it may not be downloaded or copied without permission.
\n\nUnless otherwise indicated, all IntechOpen websites are the property of IntechOpen.
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\n\nPolicy last updated: 2016-06-08
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