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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194608
• Other study ID #: 0000-347
• Secondary ID: LCE#40378
• Status: Completed
• Phase: N/A
• First received: July 16, 2014
• Last updated: June 23, 2015
• Start date: December 2011
• Est. completion date: July 2013

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in blood glucose level		Baseline and 12 months	No
Primary	Change from baseline in blood pressure		Baseline and 12 months	No
Primary	Change from baseline in body mass index		Baseline and 12 months	No
Secondary	Percentage of participants who achieved hemoglobin A1c (HbA1c) <7.0%		Up to 12 months	No
Secondary	Percentage of participants who achieved blood pressure <130/80 mmHg		Up to 12 months	No
Secondary	Percentage of participants who achieved low-density lipoprotein (LDL) cholesterol <100 mg/dL		Up to 12 months	No
Secondary	Percentage of participants requiring therapy modifications		Up to 12 months	No
Secondary	Change from baseline in total cholesterol		Baseline, 6 months, and 12 months	No
Secondary	Change from baseline in high-density lipoprotein (HDL) cholesterol		Baseline, 6 months, and 12 months	No
Secondary	Change from baseline in LDL cholesterol		Baseline, 6 months, and 12 months	No
Secondary	Change from baseline in triglycerides		Baseline, 6 months, and 12 months	No
Secondary	Change from baseline in cardiovascular risk score		Baseline, 6 months, and 12 months	No
Secondary	Number of emergency room visits and hospital admissions		Up to 12 months	No
Secondary	Number of office visits and home visits		Up to 12 months	No
Secondary	Change from baseline in the number and doses of drugs for treatment of diabetes		Baseline and 12 months	No
Secondary	Change from baseline in the number and doses of drugs for treatment of hypertension		Baseline and 12 months	No
Secondary	Change from baseline in the number and doses of drugs for treatment of dyslipidemia		Baseline and 12 months	No
Secondary	Participant overall satisfaction level		Up to 12 months	No
Secondary	Participant compliance with protocol-provided devices		Up to 12 months	No
Secondary	Number of participants who experienced hypoglycemia		Up to 12 months	Yes
Secondary	Number of hypoglycemic episodes		Up to 12 months	Yes
Secondary	Number of participants who experienced severe/symptomatic hypoglycemia		Up to 12 months	Yes
Secondary	Number of severe/symptomatic hypoglycemic episodes		Up to 12 months	Yes