TeLIPro Health Program - Active With Diabetes

Study Overview
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Brief Summary
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In a randomized-controlled trial the hypothesis should be tested that the Telemedical Lifestyle Intervention Program TeLIPro could significantly improve HbA1c (primary outcome), body weight and composition, cardiovascular risk factors, quality of life, eating behavior, and medication demand (secondary outcomes) in type 2 diabetes mellitus (T2DM) patients.

Detailed Description
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T2DM patients, assured at the health insurance AOK Rhineland / Hamburg will be randomized into two parallel groups. In addition to routine care both groups will be provided a scale as well as a step counter and access to a secured online portal. The TeLIPro group will additionally got a glucose meter with test stripes fpr self-monitoring of blood glucose and telemedical coaching. Participants of both groups will enter their anthropometric and metabolic data into a database on quarterly basis. In addition, the costs for diabetes-specific treatment, inpatient and outpatient treatment costs and drug costs will be analyzed on the basis of the routine data of the AOK Rhineland / Hamburg. Patient preference for type 2 diabetes intervention will be recorded using Discrete Choice Experiment (DCE) questionnaires at the beginning of the program and at the end of the intervention. As part of the development and validation of the DCE, focus groups are used to determine the DCE attributes. In addition, focus groups should also be used during the data collection in order to obtain additional information on patient preferences by means of qualitative analysis.

Official Title
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The Telemedical Lifestyle Intervention Program TeLIPro (TeLIPro Health Program - Active With Diabetes)

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: Scale
* Device: Step counter
* Device: Blood glucose meter with test stripes
* Other: Access to the online portal
* Other: Telemedical coaching


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes mellitus body mass index of et least 27 kg/m2 Exclusion Criteria: acute infections chronic diseases other than type 2 diabetes and hypertension (e.g., cancer, chronic obstructive pulmonary disease, asthma, dementia, chronic gut diseases, psychoses, liver cirrhosis, macronephropathy/nephropathy, kidney insufficiency with glomerular filtration rate <30 ml/min/1.73 m2) acute chemotherapy or chronic cortisol treatment smoking cessation for <3 months and/or planned smoking cessation during study pregnancy or breast-feeding

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
Interventional Model Description: randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>The control group will be provided a scale, a step counter as well as access to the online portal and will remain in routine care. | Device: Scale<br>* self-monitoring of body weight; with automatic data transfer into the personalized and secured online portal<br>Device: Step counter<br>* self-monitoring of physical activity; with automatic data transfer into the personalized and secured online portal<br>Other: Access to the online portal<br>* self-monitoring of health parameters<br>|
| Experimental: TeLIPro group<br>The TeLIPro group will be provided a scale, a step counter, a blood glucose meter with test stripes as well as access to the online portal and will get telemedical coaching. | Device: Scale<br>* self-monitoring of body weight; with automatic data transfer into the personalized and secured online portal<br>Device: Step counter<br>* self-monitoring of physical activity; with automatic data transfer into the personalized and secured online portal<br>Device: Blood glucose meter with test stripes<br>* self-monitoring of blood glucose; with automatic data transfer into the personalized and secured online portal<br>Other: Access to the online portal<br>* self-monitoring of health parameters<br>Other: Telemedical coaching<br>* regular telephone calls providing information about T2DM, healthy lifestyle, low-carbohydrate diet and physical activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c change | estimated treatment difference between groups of HbA1c change (in T2DM patients with diabetes duration of ≥ 5 years) | 12 months | 
| remission rate | number of participants with an HBA1c <6.5% (in T2DM patients with diabetes duration of < 5 years) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting blood glucose change | estimated treatment difference between groups of fasting blood glucose change | 12 months | 
| weight change | estimated treatment difference between groups of weight change | 12 months | 
| body mass index change | estimated treatment difference between groups of body mass index change | 12 months | 
| systolic blood pressure change | estimated treatment difference between groups of systolic blood pressure change | 12 months | 
| diastolic blood pressure change | estimated treatment difference between groups of diastolic blood pressure change | 12 months | 
| total cholesterol change | estimated treatment difference between groups of total cholesterol change | 12 months | 
| high-density lipoprotein (HDL) cholesterol change | estimated treatment difference between groups of high-density lipoprotein (HDL) cholesterol change | 12 months | 
| low-density lipoprotein (LDL) cholesterol change | estimated treatment difference between groups of low-density lipoprotein (LDL) cholesterol change | 12 months | 
| triglyceride change | estimated treatment difference between groups of triglyceride change | 12 months | 
| number of steps | estimated treatment difference between groups of number of steps | 12 months | 
| antidiabetic medication change | estimated treatment difference between groups of antidiabetic medication change | 12 months | 
| diabetes-specific treatment costs | estimated treatment difference between groups of diabetes-specific treatment costs | 12 months | 
| inpatient costs | estimated treatment difference between groups of inpatient costs | 12 months | 
| outpatient costs | estimated treatment difference between groups of outpatient costs | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2