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Diabetes Care Management Trial of Telemetric Monitoring (TELEGAP)

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ClinicalTrials.gov Identifier: NCT01775878
Recruitment Status : Completed
First Posted : January 25, 2013
Last Update Posted : January 25, 2013
Sponsor:
Collaborator:
Samsung Electronics
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:

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 or disease Intervention/treatment Phase
Diabetes Device: Telemonitoring Device Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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)
Study Start Date : May 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

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 Name: Samsung Health Diary




Primary Outcome Measures :
  1. Fructosamine [ Time Frame: 6 weeks ]
    Change from baseline to 6 weeks in serum fructosamine levels

  2. glycosylated hemoglobin [ Time Frame: 6 months ]
    change from baseline to 6 months in serum HbA1c levels


Secondary Outcome Measures :
  1. blood pressure [ Time Frame: 6 weeks and 6 months ]
    goal of systolic < 130 mmHg and diastolic < 70 mmHg



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775878


Sponsors and Collaborators
Kaiser Permanente
Samsung Electronics
Investigators
Principal Investigator: Jerry Minkoff, MD Kaiser Permanente

Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT01775878     History of Changes
Other Study ID Numbers: CN-08JMink-01
First Posted: January 25, 2013    Key Record Dates
Last Update Posted: January 25, 2013
Last Verified: January 2013

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