Telemonitoring System Study in Participants With Type 2 Diabetes Mellitus (MK-0000-347)
Not Applicable
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Interventions
- Device: Home telehealth system
- Registration Number
- NCT02194608
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telemedicine system Home telehealth 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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