Telemedicine as a Means to Achieving Good Diabetes Control Among Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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The aim of the study is to investigate the effect of telemedicine among the group of type-2-diabetics who, despite rehabilitation, remain poorly regulated. To describe the patients with regards to vulnerability and social resources and to determine wich groups benefit the most from telemedicine.

Detailed Description
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Type-2-diabetes is a growing healthcare problem. Both because of the increasing amount of patients and because of the complications of diabetes. Non-pharmacological treatment is considered fundamental in the treatment of patients with type-2-diabetes. In the Community of Copenhagen, all patients diagnosed with diabetes receive rehabilitation. The rehabilitation consists of counseling with regards to nutrition, physical activity, smoking cessation and education about diabetes. Some patients however, remain poorly regulated despite rehabilitation as well as pharmacological treatment. A total number of 165 patients will be randomized to intervention group or standard care.

Official Title
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The Copenhagen Rehabilitation Trial Part 2: Telemedicine as a Means to Achieve Good Diabetes Control Among Patients With Type 2 Diabetes

Conditions
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Type 2 Diabetes, Poor Glycemic Control, Medication Adherence

Intervention / Treatment
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* Behavioral: Telemedicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HbA1c > 7,5% BMI > 25 Spoken danish Completed a rehabilitation program more than 6 months ago Exclusion Criteria: HbA1c < 7,5% BMI < 25 Need of interpreter

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine<br>Monthly video consultations with a nurse as add-on to standard treatment. | Behavioral: Telemedicine<br>* Monthly video consultations with a nurse as add-on to standard treatment. The nurse has access to bloodsugar- bloodpressure and weight measurements uploaded by the participants to a tablet computer directly from the devices. Patients on Insulin measure bloodsugar twice a day (fasting and before their evening meal). Patients not on Insulin measure bloodsugar once a week (fasting and before their evening meal). All participants measure bloodpressure and weight once a week. The intervention lasts 32 weeks.<br>|
| No Intervention: Standard treatment<br>Standard diabetes control at a Diabetes Clinic or GP | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in HbA1c |  | Baseline, 16 weeks, 32 weeks, 6 months after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting total cholesterol, LDL, HDL, triglycerides |  | Baseline, 32 weeks | 
| Beta-cell function test (HOMA) |  | Baseline, 32 weeks | 
| Weight |  | Baseline, 32 weeks | 
| Bloodpressure |  | Baseline, 32 weeks | 
| Physical activity |  | Baseline, 32 weeks | 
| Change in quality of life |  | Baseline, 32 weeks | 
| Waist circumference |  | Baseline, 32 weeks | 
| Hip circumference |  | Baseline, 32 weeks | 
| Body mass index |  | Baseline, 32 weeks | 
| Use of medication |  | Baseline, 32 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes, Quality of life, Lifestyle intervention, Telemedicine, Videoconference