Tele-Diab: Electronic Diary for Patients With Type 2 Diabetes Mellitus
This study is currently recruiting participants.
Verified August 2011 by Medical University of Vienna
Sponsor:
Medical University of Vienna
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Hyperinsulinism |
ClinicalTrials.gov processed this record on May 19, 2013