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Completed

NCT Number: NCT02194608

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change from baseline in blood glucose level

    Time frame: Baseline and 12 months

  2. Change from baseline in blood pressure

    Time frame: Baseline and 12 months

  3. Change from baseline in body mass index

    Time frame: Baseline and 12 months

Secondary outcomes

  1. Percentage of participants who achieved hemoglobin A1c (HbA1c) <7.0%

    Time frame: Up to 12 months

  2. Percentage of participants who achieved blood pressure <130/80 mmHg

    Time frame: Up to 12 months

  3. Percentage of participants who achieved low-density lipoprotein (LDL) cholesterol <100 mg/dL

    Time frame: Up to 12 months

  4. Percentage of participants requiring therapy modifications

    Time frame: Up to 12 months

  5. Change from baseline in total cholesterol

    Time frame: Baseline, 6 months, and 12 months

  6. Change from baseline in high-density lipoprotein (HDL) cholesterol

    Time frame: Baseline, 6 months, and 12 months

  7. Change from baseline in LDL cholesterol

    Time frame: Baseline, 6 months, and 12 months

  8. Change from baseline in triglycerides

    Time frame: Baseline, 6 months, and 12 months

  9. Change from baseline in cardiovascular risk score

    Time frame: Baseline, 6 months, and 12 months

  10. Number of emergency room visits and hospital admissions

    Time frame: Up to 12 months

  11. Number of office visits and home visits

    Time frame: Up to 12 months

  12. Change from baseline in the number and doses of drugs for treatment of diabetes

    Time frame: Baseline and 12 months

  13. Change from baseline in the number and doses of drugs for treatment of hypertension

    Time frame: Baseline and 12 months

  14. Change from baseline in the number and doses of drugs for treatment of dyslipidemia

    Time frame: Baseline and 12 months

  15. Participant overall satisfaction level

    Time frame: Up to 12 months

  16. Participant compliance with protocol-provided devices

    Time frame: Up to 12 months

  17. Number of participants who experienced hypoglycemia

    Time frame: Up to 12 months

  18. Number of hypoglycemic episodes

    Time frame: Up to 12 months

  19. Number of participants who experienced severe/symptomatic hypoglycemia

    Time frame: Up to 12 months

  20. Number of severe/symptomatic hypoglycemic episodes

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 18, 2014
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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