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

Merck Sharp & Dohme LLC0 sites500 target enrollmentDecember 2011

ConditionsType 2 Diabetes Mellitus

Overview

Phase: N/A
Intervention: Not specified
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 500
Primary Endpoint: Change from baseline in blood glucose level
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

December 2011

End Date

July 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

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

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

Number of emergency room visits and hospital admissions(Up to 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)
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)
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 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)
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)