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NCT01058889 Clinical Trial

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

Insulin Resistance Clinical Trial

— Tele-Diab  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01058889
Other study ID # 352/2006
Secondary ID
Status Recruiting
Phase Phase 3
First received January 28, 2010
Last updated August 4, 2011
Start date November 2009
Est. completion date August 2012

Study information
Verified date August 2011
Source Medical University of Vienna
Contact Karin Schindler, PhD
Phone +43140400
Email karin.schindler@meduniwien.ac.at
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date August 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Telemedical device
Monitoring of blood glucose,insulin dose, blood pressure, lifestyle factors with the telemedical device. Monitoring of system availability, percentage of data transfer, acceptance.

Locations
Country Name City State
Austria Medical University Vienna, Allgemeines Krankenhaus Vienna

Sponsors (2)
Lead Sponsor Collaborator
Medical University of Vienna National Bank of Austria

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary System availability, acceptance, transmission rate 3 months No
Secondary HbA1c 3 months No
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