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Diabetes Care Management Trial of Telemetric Monitoring (TELEGAP)

This study has been completed.
Sponsor:
Collaborator:
Samsung electronics
Information provided by (Responsible Party):
Kaiser Permanente
ClinicalTrials.gov Identifier:
NCT01775878
First received: January 23, 2013
Last updated: NA
Last verified: January 2013
History: No changes posted
  Purpose

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


Condition Intervention
Diabetes
 Device: Telemonitoring Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Study Comparing Usual Diabetes Care Management to Telemetric Home-based Monitoring of Glucose and Blood Pressure in Patients With Diabetes (TELEGAP)

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by Kaiser Permanente:

Primary Outcome Measures:
  • Fructosamine [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Change from baseline to 6 weeks in serum fructosamine levels

  • glycosylated hemoglobin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    change from baseline to 6 months in serum HbA1c levels


Secondary Outcome Measures:
  • blood pressure [ Time Frame: 6 weeks and 6 months ] [ Designated as safety issue: No ]
    goal of systolic < 130 mmHg and diastolic < 70 mmHg


Enrollment: 254
Study Start Date: May 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Samsung Health Diary

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775878

Sponsors and Collaborators
Kaiser Permanente
Samsung electronics
Investigators
Principal Investigator: Jerry Minkoff, MD Kaiser Permanente
  More Information

No publications provided

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01775878     History of Changes
Other Study ID Numbers: CN-08JMink-01
Study First Received: January 23, 2013
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Kaiser Permanente:
Diabetes
HbA1c
Fructosamine
Blood Pressure
Telemonitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013