Open access peer-reviewed chapter

# Quality of Life in Telemedicine-Based Interventions for Type-2 Diabetes Patients: The TECNOB Project

By Stefania Corti, Gian Mauro Manzoni, Giada Pietrabissa and Gianluca Castelnuovo

Submitted: April 16th 2012Reviewed: February 7th 2013Published: December 13th 2013

DOI: 10.5772/56009

## 1. Introduction

Worldwide, diabetes has become an overwhelming problem due to the increase of overweightness and obesity. As estimated by WHO in 2011 [1], 346 million people globally suffer from diabetes and there is an approximate 3,4 million mortality rate from the consequences of DMT. WHO predicts that diabetes related deaths will double by 2030. Throughout the course of time, diabetes damages the heart, blood vessels, eyes, kidneys, and nerves. Indeed, 50% of people with diabetes die due to cardiovascular disease (primarily heart disease and stroke). Reduced blood flow and neuropathic pain can increases the chances of complications such as ulcers and even limb amputations. Diabetic retinopathy represents a significant cause of blindness, as a consequence of damage to blood vessels in the retina. 2% of diabetics become blind after 15 years. Diabetes can result in neuropathy, whose common symptoms are tingling, pain, numbness, or weakness both in feet and hands. Diabetes is the seventh leading cause of death in the US [2]. These complications are very important determinants of quality of life. Low QoL may, in turn, affect metabolic control by reducing regimen adherence. Treatment of diabetes involves lowering blood glucose and the levels of other known risk factors that could damage blood vessels. Lifestyle measures, such as the control of body weight, physical activity, a healthy diet and avoidance of tobacco use, have been shown to be effective in preventing the onset of type 2 diabetes.

## 4. Technology for obesity project

In order to determine which features of telemedicine and internet-based interventions are critical in a cost-effective approach, TECNOB project has been developed. TECNOB (TEChNology for OBesity) Project is a comprehensive two-phase stepped down program enhanced by telemedicine for the medium-term treatment of obese and diabetic people seeking intervention for weight loss [87, 88]. Its core features are the hospital-based intensive treatment (1-month), that consists of diet therapy, physical training and psychological counselling, and the continuity of care at home using new information and communication technologies (ICT) such as internet and mobile cell phones. The effectiveness of the TECNOB program compared with usual care (hospital-based treatment only) will be evaluated in a randomized controlled trial (RCT) with a 12- month follow-up. The primary outcome is weight in kilograms. Secondary outcome measures are energy expenditure measured using an electronic armband, glycated haemoglobin, binge eating, self-efficacy in eating and weight control, body satisfaction, healthy habit formation, disordered eating-related behaviours and cognitions, psychopathological symptoms and weight-related quality of life (The Self-Report Habit Index – SRHI[89], Weight Efficacy Life Style Questionnaire – WELSQ [90], Body Uneasiness Test – BUT [91], Binge Eating Scale – BES [92, 93], Eating Disorder Inventory EDI-2 [94], Symptom Check List - SCL-90 [95], Impact of Weight on Quality of Life-Lite - IWQOL-Lite [96], The Outcome Questionnaire - OQ 45.2 [97]). According to the Consensus Statement on the Worldwide Standardization of the Haemoglobin A1C Measurement [98], the haemoglobin A1C (A1C) assay has become the gold-standard in measurement of chronic glycaemia for over two decades. Anchored in the knowledge that elevated A1C values increase the likelihood of the micro-vascular complications of diabetes (and perhaps macro-vascular complications as well), the assay has become the cornerstone for the assessment of diabetes care. In this study, we adopt the measurement method (concentration of only one molecular species of glycated A1C) and results reporting (mmol/mol and derived NGSP %) developed by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)

In this paper only weight and disordered eating-related behaviours and cognitions (EDI- 2) data were analyzed and reported. Weight was assessed with the participant in lightweight clothing with shoes removed on a balance beam scale. The EDI-2 is a widely used, standardized, self-report measure of psychological symptoms commonly associated with anorexia nervosa, bulimia nervosa and other eating disorders. The EDI-2 does not yield a specific diagnosis of eating disorder. It is aimed at the measurement of psychological traits or symptom clusters presumed to have relevance to understanding and treatment of eating disorders. The EDI-2 consists of 11 subscales derived from 91 items. Three of the subscales were designed to assess attitudes and behaviours concerning eating, weight and shape (Drive for Thinness, Bulimia, Body Dissatisfaction) and the remaining eight ones tapped more general constructs or psychological traits clinically relevant to eating disorders (Ineffectiveness, Perfection, Interpersonal Distrust, Interoceptive Awareness, Maturity Fears, Asceticism, Impulse Regulation and Social Insecurity) [94, 99].

## 5. Conclusion

Some preliminary results are now available. As indicated in a recent paper [87], at present 72 obese patients with type 2 diabetes have been recruited and randomly allocated to the TECNOB program (n=37) or to a control condition (n=39). However, only 34 participants have completed at least the 3-month follow-up and have been included in this ad interim analysis. 21 out of them have reached also the 6-month follow-up and 13 have achieved the end of the program. The first ad interim analysis of the data from the TECNOB study has not revealed any significant difference between the TECNOB program and a control condition in weight change at 3, 6 and 12 months. Within-group analysis showed significant reductions of initial weight at all time-points but not at 12-month follow-up. The median percentage of initial weight loss for the whole sample was -5,1 kg (-6,6 to-3,7) at discharge from the hospital. Completers analysis of data collected at 6 and 12 months showed that participants regained back part of the weight loss and the difference between weight at baseline and at 12-month follow-up was no more statistically significant.

Differences in eating-related behaviours and cognitions (EDI-2) were also examined. At baseline, the control group showed higher scores in many EDI-2 scales, i.e. Drive for Thinness, Ineffectiveness, Interoceptive awareness, Impulse regulation and Social Insecurity, compared with the TECNOB group. Notably, these groups included selected participants (those patients that have come through at least the 3-month follow-up) and such statistically significant differences were not found when the original groups were compared. Control group showed higher scores also in Interpersonal distrust at 12 months. However, this result has to be seen with caution because of the few patients (n=12) who have achieved the end of the program at present.

Remarkably, sample sizes at 6 and 12 months are small (n=21 and n=12 respectively) due to the ongoing status of the study and these results may be unreliable. These ad interim findings did not support the effectiveness of the TECNOB protocol over a control condition. Notably, this kind of data analysis (ad interim analysis) is underpowered and results obtained may not be reliable, in particular at 6 and 12 months. However, we gained a significant insight into an important component of the study design, i.e. the hospital-based program. The effect that such uncontrolled factor has on weight loss was very high and probably overwhelmed the effect of the TECNOB intervention. Hence, much statistical power is necessary to enhance the chance to detect the effect of the TECNOB program: the hospital-based program has a very high effect in the first months after discharge but such effect may reduce in the long term. A 12-month follow-up is probably sufficient to detect the TECNOB effect over and above the weakened effect of the hospital base program. Study and information collection is an on-going process and complete results, in particular about glycated haemoglobin and QoL indices, will be published in the next years.

## Acknowledgments

This chapter is related to the TECNOB Project (Technology for Obesity Project) supported by the “Compagnia di San Paolo” private foundation. Our technological partners are TELBIOS (http://www.telbios.it) and METEDA (http://www.meteda.it).

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Stefania Corti, Gian Mauro Manzoni, Giada Pietrabissa and Gianluca Castelnuovo (December 13th 2013). Quality of Life in Telemedicine-Based Interventions for Type-2 Diabetes Patients: The TECNOB Project, Telemedicine, Ramesh Madhavan and Shahram Khalid, IntechOpen, DOI: 10.5772/56009. Available from:

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