Diabetes Care Management Trial of Telemetric Monitoring (TELEGAP)

January 23, 2013 updated by: Kaiser Permanente

A Randomized Study Comparing Usual Diabetes Care Management to Telemetric Home-based Monitoring of Glucose and Blood Pressure in Patients With Diabetes (TELEGAP)

The study is a two-arm, parallel-comparison, single-blind, randomized controlled trial, and will be offered to Kaiser Permanente members aged 18 - 75 years old who present to the Santa Rosa Diabetes Care Management Center with Type 2 diabetes mellitus. Participants will be randomly assigned to one of two treatment arms. The telemedicine group or the group receiving usual care (the control group).

This study hopes to show the usefulness of this telemonitoring technology and more specifically, to assess whether this device improves markers of control of diabetes, glycemic control, and cardiovascular risk factors

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

254

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 - 75 years old,
  • diagnosis of type 2 diabetes mellitus for at least 1 month,
  • eligible for and referred to the diabetes care management program,
  • HbA1c values in the range: 7.5% to 10.5%.

Exclusion Criteria:

  • Weight > 330 lbs,
  • estimated glomerular filtration rate (GFR) < 45,
  • unstable coronary artery disease,
  • severe peripheral vascular disease which restricted exercise,
  • end-stage liver disease,
  • undergoing treatment for cancer,
  • pregnant or not using appropriate birth control,
  • no broadband internet access in their homes.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Usual Care
This arm received usual care from the diabetes care managers
EXPERIMENTAL: Telemonitoring Device
Patients in this arm received a telemonitoring device installed in their homes
Device: Telemonitoring Device
Telemonitoring device was installed in patients' homes
Other Names:
  • Samsung Health Diary

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fructosamine
Time Frame: 6 weeks
Change from baseline to 6 weeks in serum fructosamine levels
6 weeks
glycosylated hemoglobin
Time Frame: 6 months
change from baseline to 6 months in serum HbA1c levels
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: 6 weeks and 6 months
goal of systolic < 130 mmHg and diastolic < 70 mmHg
6 weeks and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

Samsung Electronics

Investigators

  • Principal Investigator: Jerry Minkoff, MD, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

January 23, 2013

First Submitted That Met QC Criteria

January 23, 2013

First Posted (ESTIMATE)

January 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 25, 2013

Last Update Submitted That Met QC Criteria

January 23, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN-08JMink-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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