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| Name | Class |
|---|---|
| AOK Rheinland/Hamburg | INDUSTRY |
| German Institute for Telemedicine and Health Promotion | OTHER |
| German Diabetes Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | 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. |
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| TeLIPro group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scale | Device | self-monitoring of body weight; with automatic data transfer into the personalized and secured online portal |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernd Altpeter | Deutsches Institut für Telemedizin und Gesundheitsförderung | Study Chair |
| Sibel Altin | AOK Rheinland/Hamburg | Study Chair |
| Andrea Icks, PhD | Deusches Diabetes Zentrum | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West German Centre of Diabetes and Health | Düsseldorf | 40591 | Germany |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014894 | Weights and Measures |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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randomized controlled trial
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| Step counter | Device | self-monitoring of physical activity; with automatic data transfer into the personalized and secured online portal |
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| Blood glucose meter with test stripes | Device | self-monitoring of blood glucose; with automatic data transfer into the personalized and secured online portal |
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| Access to the online portal | Other | self-monitoring of health parameters |
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| Telemedical coaching | Other | regular telephone calls providing information about T2DM, healthy lifestyle, low-carbohydrate diet and physical activity |
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| 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 |
| D004700 | Endocrine System Diseases |