Diabetes Coaching Study

Study Overview
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Brief Summary
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The purpose of the study is to compare the effect of telemedical coaching versus telemedical control on HbA1c, weight, BMI, blood pressure, blood lipids, medication, nutrition, physical activity and quality of life in type 2 diabetes patients with poor glycaemic control.

Official Title
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Diabetes Coaching Study

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Telemedical coaching
* Other: Telemedicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 2 diabetes mellitus hemoglobin A1c (HbA1c) >7.5% at leat two different antidiabetic drugs body mass index >27kg/m2 Exclusion Criteria: acute infections diagnosed chronic diseases other than type 2 diabetes and hypertension, e.g. cancer, chronic obstructive pulmonary disease (COPD), asthma, dementia, chronic gut diseases, psychoses, liver cirrhosis, (macro-) nephropathy, kidney insufficiency with glomerular filtration rate (eGFR) < 30ml / min / 1.73 m2 acute chemotherapy or chronic cortisol treatment smoking cessation for less than 3 months and or planned smoking cessation during study known intolerance of any ingredient of Almased (especially soy protein) pregnancy or breast feeding, lack of contraception (women) other study participation in the last 6 months prior to study start

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedical Coaching<br>Patients will receive telemedical devices i.e. for the measurement of blood glucose, weight and physical activity. These devices will transfer the data to a data collector with a SIM card which sends the data to a data portal, which can be monitored by the participant and the coach. Health coaches which will have close phone contact to patients, supporting them to reduce weight and increase physical activity. In the first 12 weeks, patients will follow a formula diet (Almased) to achieve an initial weight reduction. | Behavioral: Telemedical coaching<br> <br> Other: Telemedicine<br> <br> |
| Active Comparator: Telemedicine<br>Patients will receive telemedical devices i.e. for the measurement of blood glucose, weight and physical activity. These devices will transfer the data to a data collector with a SIM card which sends the data to a data portal which can be monitored by the participant. | Behavioral: Telemedical coaching<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Difference in HbA1c (at end of study vs. baseline) between the groups | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight | Difference in weight (at end of study vs. baseline) between the groups | 12 months | 
| antidiabetic medication | Difference in antidiabetic medication (at end of study vs. baseline) between the groups | 12 months | 
| Cardiovascular risk parameters (blood pressure, blood lipids) | Difference in cardiovascular risk parameters (i.e. blood pressure, blood lipids) (at end of study vs. baseline) between the groups | 12 months | 
| physical activity (step count) | Difference in physical activity (at end of study vs. baseline) between the groups | 12 months | 
| nutrition | Difference in nutrition (at end of study vs. baseline) between the groups | 12 months | 
| quality of life | Difference in quality of life (at end of study vs. baseline) between the groups | 12 months |