A Randomized Clinical Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Individuals With Type 2 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 500
- Primary Endpoint
- Change from baseline in blood glucose level
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Telemedicine system
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.
Intervention: Home telehealth system (Device)
Usual care
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.
Outcomes
Primary Outcomes
Change from baseline in blood glucose level
Time Frame: Baseline and 12 months
Change from baseline in blood pressure
Time Frame: Baseline and 12 months
Change from baseline in body mass index
Time Frame: Baseline and 12 months
Secondary Outcomes
- 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)
- 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)
- 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)
- Number of severe/symptomatic hypoglycemic episodes(Up to 12 months)