Diabetes Care Management Trial of Telemetric Monitoring

Study Overview
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Brief Summary
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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

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

Conditions
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Diabetes

Intervention / Treatment
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* Device: Telemonitoring Device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>This arm received usual care from the diabetes care managers | |
| Experimental: Telemonitoring Device<br>Patients in this arm received a telemonitoring device installed in their homes | Device: Telemonitoring Device<br>* Telemonitoring device was installed in patients' homes<br>* Other names: Samsung Health Diary;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, HbA1c, Fructosamine, Blood Pressure, Telemonitoring