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Completed

NCT Number: NCT01775878

Diabetes Care Management Trial of Telemetric Monitoring

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

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telemonitoring Device

Device

Telemonitoring device was installed in patients' homes

Other names: Samsung Health Diary

Primary outcomes

  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 outcomes

  1. blood pressure

    Time frame: 6 weeks and 6 months

    goal of systolic < 130 mmHg and diastolic < 70 mmHg

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • Samsung Electronics

Registry information

Official study title

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

Acronym: TELEGAP

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 25, 2013
Registry last updated
Jan 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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