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

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

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 Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Device: Home telehealth system

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Home telehealth system; 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Publications and helpful links

General Publications

• Nicolucci A, Cercone S, Chiriatti A, Muscas F, Gensini G. A Randomized Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Patients with Type 2 Diabetes. Diabetes Technol Ther. 2015 Aug;17(8):563-70. doi: 10.1089/dia.2014.0355. Epub 2015 Jul 8.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 18, 2014

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 23, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 0000-347; LCE#40378 (Other Identifier: Merck)