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

Phase 3

• Conditions: Diabetes Mellitus Type 2; Insulin Resistance
• Interventions: Device: Telemedical device

• Registration Number: NCT01058889
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-01-28
• Study First Posted: 2010-01-29
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-05
• Primary Completion: 2012-08
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedical device	Telemedical device	Patient will receive a blood glucose measurement device and a telemedical device to monitor blood glucose measurements.
Treatment as usual	Telemedical device	-

Primary Outcome Measures

Name	Time	Method
System availability, acceptance, transmission rate	3 months

Secondary Outcome Measures

Name	Time	Method
HbA1c	3 months

Trial Locations

Locations (1)

Medical University Vienna, Allgemeines Krankenhaus; 🇦🇹 Vienna, Austria