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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
500
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.
Change from baseline in blood glucose level
Time frame: Baseline and 12 months
Change from baseline in blood pressure
Time frame: Baseline and 12 months
Change from baseline in body mass index
Time frame: Baseline and 12 months
Percentage of participants who achieved hemoglobin A1c (HbA1c) <7.0%
Time frame: Up to 12 months
Percentage of participants who achieved blood pressure <130/80 mmHg
Time frame: Up to 12 months
Percentage of participants who achieved low-density lipoprotein (LDL) cholesterol <100 mg/dL
Time frame: Up to 12 months
Percentage of participants requiring therapy modifications
Time frame: Up to 12 months
Change from baseline in total cholesterol
Time frame: Baseline, 6 months, and 12 months
Change from baseline in high-density lipoprotein (HDL) cholesterol
Time frame: Baseline, 6 months, and 12 months
Change from baseline in LDL cholesterol
Time frame: Baseline, 6 months, and 12 months
Change from baseline in triglycerides
Time frame: Baseline, 6 months, and 12 months
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Change from baseline in cardiovascular risk score
Time frame: Baseline, 6 months, and 12 months
Number of emergency room visits and hospital admissions
Time frame: Up to 12 months
Number of office visits and home visits
Time frame: Up to 12 months
Change from baseline in the number and doses of drugs for treatment of diabetes
Time frame: Baseline and 12 months
Change from baseline in the number and doses of drugs for treatment of hypertension
Time frame: Baseline and 12 months
Change from baseline in the number and doses of drugs for treatment of dyslipidemia
Time frame: Baseline and 12 months
Participant overall satisfaction level
Time frame: Up to 12 months
Participant compliance with protocol-provided devices
Time frame: Up to 12 months
Number of participants who experienced hypoglycemia
Time frame: Up to 12 months
Number of hypoglycemic episodes
Time frame: Up to 12 months
Number of participants who experienced severe/symptomatic hypoglycemia
Time frame: Up to 12 months
Number of severe/symptomatic hypoglycemic episodes
Time frame: Up to 12 months