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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Device: Home telehealth system

Study type: Interventional

Funder types: Industry

Identifiers

NCT02194608

LCE#40378 (Other Identifier)

0000-347

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 2 patient groups

Telemedicine system

Experimental group

Description:

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.

Treatment:

Device: Home telehealth system

Usual care

No Intervention group

Description:

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.