Telemonitoring System Study in Participants With Type 2 Diabetes Mellitus (MK-0000-347)

Study Overview
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Brief Summary
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The primary goal is to evaluate whether a home telehealth system that enables the participant to monitor their body weight, blood glucose values and blood pressure values, associated with remote educational support and feedback to the general practitioner, can improve metabolic control and overall cardiovascular risk in individuals with type 2 diabetes mellitus (T2DM), as compared to usual practice.

Official Title
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A Randomized Clinical Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Individuals With Type 2 Diabetes

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Device: Home telehealth system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: has type 2 diabetes treated with oral agents in monotherapy or combined therapy ± basal insulin previously educated to self-monitoring blood glucose (SMBG) use Exclusion Criteria: has type 2 diabetes non-pharmacologically treated has type 2 diabetes treated with multiple daily injections of insulin is unable to use the telemedicine system pregnancy has major cardiovascular, cerebrovascular, or peripheral vascular event in the last 6 months has any disease or condition, including alcohol or drugs abuse, that may interfere with study completion

Ages Eligible for Study
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Minimum Age: 45 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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemedicine system<br>Participants will self-test blood glucose level, weight, and blood pressure and results will be uploaded and transmitted directly via a hometelehealth system to a central location (HUB). Blood draws will be administered at baseline and follow-up visits. | Device: Home telehealth system<br>* Participants will receive a weighing machine, glucometer, and a sphygmomanometer connected through a Bluetooth system from their home to the Telehealth center via a HUB.<br>|
| No Intervention: Usual care<br>Participants will self-record their blood glucose levels, blood pressure and weight in a diary. Blood draws will be administered at baseline and follow-up visits. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in blood glucose level |  | Baseline and 12 months | 
| Change from baseline in blood pressure |  | Baseline and 12 months | 
| Change from baseline in body mass index |  | Baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who achieved hemoglobin A1c (HbA1c) <7.0% |  | Up to 12 months | 
| Percentage of participants who achieved blood pressure <130/80 mmHg |  | Up to 12 months | 
| Percentage of participants who achieved low-density lipoprotein (LDL) cholesterol <100 mg/dL |  | Up to 12 months | 
| Percentage of participants requiring therapy modifications |  | Up to 12 months | 
| Change from baseline in total cholesterol |  | Baseline, 6 months, and 12 months | 
| Change from baseline in high-density lipoprotein (HDL) cholesterol |  | Baseline, 6 months, and 12 months | 
| Change from baseline in LDL cholesterol |  | Baseline, 6 months, and 12 months | 
| Change from baseline in triglycerides |  | Baseline, 6 months, and 12 months | 
| Change from baseline in cardiovascular risk score |  | Baseline, 6 months, and 12 months | 
| Number of emergency room visits and hospital admissions |  | Up to 12 months | 
| Number of office visits and home visits |  | Up to 12 months | 
| Change from baseline in the number and doses of drugs for treatment of diabetes |  | Baseline and 12 months | 
| Change from baseline in the number and doses of drugs for treatment of hypertension |  | Baseline and 12 months | 
| Change from baseline in the number and doses of drugs for treatment of dyslipidemia |  | Baseline and 12 months | 
| Participant overall satisfaction level |  | Up to 12 months | 
| Participant compliance with protocol-provided devices |  | Up to 12 months | 
| Number of participants who experienced hypoglycemia |  | Up to 12 months | 
| Number of hypoglycemic episodes |  | Up to 12 months | 
| Number of participants who experienced severe/symptomatic hypoglycemia |  | Up to 12 months | 
| Number of severe/symptomatic hypoglycemic episodes |  | Up to 12 months |