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

Primary Purpose

Diabetes Mellitus Type 2, Insulin Resistance

Status

Unknown status

Phase

Phase 3

Locations

Austria

Study Type

Interventional

Intervention

Telemedical device

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 2 focused on measuring Diabetes mellitus Type 2, Telemedicine, Insulin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Medical University Vienna, Allgemeines KrankenhausRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telemedical device

Treatment as usual

Arm Description

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

Outcomes

Primary Outcome Measures

System availability, acceptance, transmission rate

Secondary Outcome Measures

HbA1c

Full Information

NCT ID

NCT01058889

First Posted

January 28, 2010

Last Updated

August 4, 2011

Sponsor

Medical University of Vienna

Collaborators

National Bank of Austria

1. Study Identification

Unique Protocol Identification Number

NCT01058889

Brief Title

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

Acronym

Tele-Diab

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Unknown status

Study Start Date

November 2009 (undefined)

Primary Completion Date

August 2012 (Anticipated)

Study Completion Date

August 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Medical University of Vienna

Collaborators

National Bank of Austria

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus Type 2, Insulin Resistance

Keywords

Diabetes mellitus Type 2, Telemedicine, Insulin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Telemedical device

Arm Type

Experimental

Arm Description

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

Arm Title

Treatment as usual

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

Telemedical device

Other Intervention Name(s)

mobile phone

Intervention Description

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

Primary Outcome Measure Information:

Title

System availability, acceptance, transmission rate

Time Frame

3 months

Secondary Outcome Measure Information:

Title

HbA1c

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Karin Schindler, PhD

Phone

+43140400

Ext

2032

karin.schindler@meduniwien.ac.at

First Name & Middle Initial & Last Name or Official Title & Degree

Bernhard Ludvik, MD

Phone

+43140400

Ext

4364

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernhard Ludvik, MD

Organizational Affiliation

Medical University Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University Vienna, Allgemeines Krankenhaus

City

Vienna

ZIP/Postal Code

1090

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Karin Schindler, PhD

Phone

+43140400

Ext

2032

karin.schindler@meduniwien.ac.at

First Name & Middle Initial & Last Name & Degree

Bernhard Ludvik, MD

Phone

+43140400

Ext

4364

bernhard.ludvik@meduniwien.ac.at

First Name & Middle Initial & Last Name & Degree

Bernhard Ludvik, MD

12. IPD Sharing Statement

Learn more about this trial

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

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