Tele-Diab: Electronic Diary for Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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The purpose of the study is to show if telemonitoring and automated feedback regarding glucose management, physical activity, blood pressure, and body weight improves treatment of patients with insulin dependent Type 2 Diabetes mellitus.

Detailed Description
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In this clinical trial 50 patients with insulin dependent type 2 diabetes will be randomised in two study arms: monitoring of blood glucose and blood pressure using a telemedical device or in an arm with treatment as usual. Patients will the following measurement devices: blood glucose, blood pressure. Both devices can communicate with a mobile phone, which will also be provided to the patients. The mobile phone will transfer the data to a central, safe server. Patients will receive automated reminder/feedback. Caregivers can evaluate the transferred data whenever necessary via a web-based access. Data will be presented in tables as well as trend figures.

Official Title
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Tele-Diab: Electronic Diary for Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes Mellitus Type 2, Insulin Resistance

Intervention / Treatment
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* Device: Telemedical device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes mellitus Type 2, age 18-70 years, able to use a mobile phone Exclusion Criteria: Pacemaker, intracardial defibrillator, no cure planned within the active study period.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedical device<br>Patient will receive a blood glucose measurement device and a telemedical device to monitor blood glucose measurements. | Device: Telemedical device<br>* Monitoring of blood glucose,insulin dose, blood pressure, lifestyle factors with the telemedical device. Monitoring of system availability, percentage of data transfer, acceptance.<br>* Other names: mobile phone;|
| No Intervention: Treatment as usual<br> | Device: Telemedical device<br>* Monitoring of blood glucose,insulin dose, blood pressure, lifestyle factors with the telemedical device. Monitoring of system availability, percentage of data transfer, acceptance.<br>* Other names: mobile phone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System availability, acceptance, transmission rate |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes mellitus Type 2, Telemedicine, Insulin