Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DEVICEHome 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.
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Change from baseline in high-density lipoprotein (HDL) cholesterol | Baseline, 6 months, and 12 months |
| Change from baseline in LDL cholesterol | Baseline, 6 months, and 12 months |
| Change from baseline in triglycerides | Baseline, 6 months, and 12 months |
| Change from baseline in cardiovascular risk score | Baseline, 6 months, and 12 months |
| Number of emergency room visits and hospital admissions | Up to 12 months |
| Number of office visits and home visits | Up to 12 months |
| Change from baseline in the number and doses of drugs for treatment of diabetes | Baseline and 12 months |
| Change from baseline in the number and doses of drugs for treatment of hypertension | Baseline and 12 months |
| Change from baseline in the number and doses of drugs for treatment of dyslipidemia | Baseline and 12 months |
| Participant overall satisfaction level | Up to 12 months |
| Participant compliance with protocol-provided devices | Up to 12 months |
| Number of participants who experienced hypoglycemia | Up to 12 months |
| Number of hypoglycemic episodes | Up to 12 months |
| Number of participants who experienced severe/symptomatic hypoglycemia | Up to 12 months |
| Number of severe/symptomatic hypoglycemic episodes | Up to 12 months |
Outcome results
None listed