Clinical trial NCT02194608: Telemonitoring System Study in Participants With Type 2 Diabetes Mellitus (MK-0000-347)
Official title: A Randomized Clinical Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Individuals With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-07-18
Enrollment: 500
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: Change from baseline in blood glucose level
timeFrame: Baseline and 12 months
measure: Change from baseline in blood pressure
timeFrame: Baseline and 12 months
measure: Change from baseline in body mass index
timeFrame: Baseline and 12 months
Secondary outcomes:
measure: Percentage of participants who achieved hemoglobin A1c (HbA1c) <7.0%
timeFrame: Up to 12 months
measure: Percentage of participants who achieved blood pressure <130/80 mmHg
timeFrame: Up to 12 months
measure: Percentage of participants who achieved low-density lipoprotein (LDL) cholesterol <100 mg/dL
timeFrame: Up to 12 months
measure: Percentage of participants requiring therapy modifications
timeFrame: Up to 12 months
measure: Change from baseline in total cholesterol
timeFrame: Baseline, 6 months, and 12 months
measure: Change from baseline in high-density lipoprotein (HDL) cholesterol
timeFrame: Baseline, 6 months, and 12 months
measure: Change from baseline in LDL cholesterol
timeFrame: Baseline, 6 months, and 12 months
measure: Change from baseline in triglycerides
timeFrame: Baseline, 6 months, and 12 months
measure: Change from baseline in cardiovascular risk score
timeFrame: Baseline, 6 months, and 12 months
measure: Number of emergency room visits and hospital admissions
timeFrame: Up to 12 months
measure: Number of office visits and home visits
timeFrame: Up to 12 months
measure: Change from baseline in the number and doses of drugs for treatment of diabetes
timeFrame: Baseline and 12 months
measure: Change from baseline in the number and doses of drugs for treatment of hypertension
timeFrame: Baseline and 12 months
measure: Change from baseline in the number and doses of drugs for treatment of dyslipidemia
timeFrame: Baseline and 12 months
measure: Participant overall satisfaction level
timeFrame: Up to 12 months
measure: Participant compliance with protocol-provided devices
timeFrame: Up to 12 months
measure: Number of participants who experienced hypoglycemia
timeFrame: Up to 12 months
measure: Number of hypoglycemic episodes
timeFrame: Up to 12 months
measure: Number of participants who experienced severe/symptomatic hypoglycemia
timeFrame: Up to 12 months
measure: Number of severe/symptomatic hypoglycemic episodes
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.