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

NCT ID: NCT01058889

Last Updated: 2011-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2012-08-31

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.

Conditions

Diabetes Mellitus Type 2; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telemedical device

Patient will receive a blood glucose measurement device and a telemedical device to monitor blood glucose measurements.

Group Type: EXPERIMENTAL

Telemedical device

Intervention Type: DEVICE

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

Treatment as usual

Group Type: NO_INTERVENTION

Telemedical device

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

mobile phone

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Bank of Austria

OTHER_GOV

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Medical University Vienna,

Principal Investigators

Bernhard Ludvik, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

Locations

Medical University Vienna, Allgemeines Krankenhaus

Vienna, , Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Karin Schindler, PhD

Role: CONTACT

karin.schindler@meduniwien.ac.at

+43140400 ext. 2032

Bernhard Ludvik, MD

Role: CONTACT

+43140400 ext. 4364

Facility Contacts

Karin Schindler, PhD

Role: primary

karin.schindler@meduniwien.ac.at

+43140400 ext. 2032

Bernhard Ludvik, MD

Role: backup

bernhard.ludvik@meduniwien.ac.at

+43140400 ext. 4364

Other Identifiers

352/2006

Identifier Type: -

Identifier Source: org_study_id