NCT01058889

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 29, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 5, 2011

Status Verified

August 1, 2011

Enrollment Period

2.8 years

First QC Date

January 28, 2010

Last Update Submit

August 4, 2011

Conditions

Diabetes Mellitus Type 2Insulin Resistance

Keywords

Diabetes mellitus Type 2TelemedicineInsulin

Outcome Measures

Primary Outcomes (1)

  • System availability, acceptance, transmission rate

    3 months

Secondary Outcomes (1)

  • HbA1c

    3 months

Study Arms (2)

Telemedical device

EXPERIMENTAL

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

Device: Telemedical device

Treatment as usual

NO INTERVENTION
Device: Telemedical device

Interventions

Telemedical deviceDEVICE

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

Also known as: mobile phone
Telemedical deviceTreatment as usual

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes mellitus Type 2, age 18-70 years, able to use a mobile phone

You may not qualify if:

  • Pacemaker, intracardial defibrillator, no cure planned within the active study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Vienna, Allgemeines Krankenhaus

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Bernhard Ludvik, MD

    Medical University Vienna

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karin Schindler, PhD

CONTACT

+43140400karin.schindler@meduniwien.ac.at

Bernhard Ludvik, MD

CONTACT

+43140400

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 28, 2010

First Posted

January 29, 2010

Study Start

November 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

August 5, 2011

Record last verified: 2011-08

Locations

AU(1)