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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Medical University of Vienna.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Bank of Austria
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01058889
First received: January 28, 2010
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus Type 2
Insulin Resistance
Device: Telemedical device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tele-Diab: Electronic Diary for Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • System availability, acceptance, transmission rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Telemedical device
Patient will receive a blood glucose measurement device and a telemedical device to monitor blood glucose measurements.
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.
Other Name: mobile phone
No Intervention: Treatment as usual 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.
Other Name: mobile phone

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058889

Contacts
Contact: Karin Schindler, PhD +43140400 ext 2032 karin.schindler@meduniwien.ac.at
Contact: Bernhard Ludvik, MD +43140400 ext 4364

Locations
Austria
Medical University Vienna, Allgemeines Krankenhaus Recruiting
Vienna, Austria, 1090
Contact: Karin Schindler, PhD    +43140400 ext 2032    karin.schindler@meduniwien.ac.at   
Contact: Bernhard Ludvik, MD    +43140400 ext 4364    bernhard.ludvik@meduniwien.ac.at   
Principal Investigator: Bernhard Ludvik, MD         
Sponsors and Collaborators
Medical University of Vienna
National Bank of Austria
Investigators
Principal Investigator: Bernhard Ludvik, MD Medical University Vienna
  More Information

No publications provided

Responsible Party: Bernhard Ludvik, MD, Prof., Medical University Vienna,
ClinicalTrials.gov Identifier: NCT01058889     History of Changes
Other Study ID Numbers: 352/2006
Study First Received: January 28, 2010
Last Updated: August 4, 2011
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Diabetes mellitus Type 2
Telemedicine
Insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases

ClinicalTrials.gov processed this record on October 20, 2014