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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02194608
First received: July 16, 2014
Last updated: NA
Last verified: July 2014
History: No changes posted
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Device: Home telehealth system

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomized Clinical Trial on Home Telemonitoring for the Management of Metabolic and Cardiovascular Risk in Individuals With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Change from baseline in blood glucose level [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in blood pressure [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]
  • Change from baseline in body mass index [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 500
Study Start Date: December 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02194608     History of Changes
Other Study ID Numbers: 0000-347, LCE#40378
Study First Received: July 16, 2014
Last Updated: July 16, 2014
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 22, 2014