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

NCT02194608 | Completed

• 2 other identifiers: 0000-347LCE#40378
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (20)

• 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

Study Arms (2)

Telemedicine system

EXPERIMENTAL

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

Usual care

NO INTERVENTION

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.

Interventions

Home telehealth system DEVICE

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.

Telemedicine system

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• has type 2 diabetes
• treated with oral agents in monotherapy or combined therapy ± basal insulin
• previously educated to self-monitoring blood glucose (SMBG) use

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 26154338 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 18, 2014
• Study Start: December 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 24, 2015

Record last verified: 2015-06