Diabetes Care Management Trial of Telemetric Monitoring

Kaiser Permanente254 enrolled

Overview

The study is a two-arm, parallel-comparison, single-blind, randomized controlled trial, and will be offered to Kaiser Permanente members aged 18 - 75 years old who present to the Santa Rosa Diabetes Care Management Center with Type 2 diabetes mellitus. Participants will be randomly assigned to one of two treatment arms. The telemedicine group or the group receiving usual care (the control group). This study hopes to show the usefulness of this telemonitoring technology and more specifically, to assess whether this device improves markers of control of diabetes, glycemic control, and cardiovascular risk factors

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

254

Conditions

Diabetes

Interventions

Telemonitoring DeviceDEVICE

Telemonitoring device was installed in patients' homes

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 - 75 years old, * diagnosis of type 2 diabetes mellitus for at least 1 month, * eligible for and referred to the diabetes care management program, * HbA1c values in the range: 7.5% to 10.5%. Exclusion Criteria: * Weight \> 330 lbs, * estimated glomerular filtration rate (GFR) \< 45, * unstable coronary artery disease, * severe peripheral vascular disease which restricted exercise, * end-stage liver disease, * undergoing treatment for cancer, * pregnant or not using appropriate birth control, * no broadband internet access in their homes.

Outcomes

Primary Outcomes

Fructosamine

Change from baseline to 6 weeks in serum fructosamine levels

Time frame: 6 weeks

glycosylated hemoglobin

change from baseline to 6 months in serum HbA1c levels

Time frame: 6 months

Secondary Outcomes

blood pressure

goal of systolic \< 130 mmHg and diastolic \< 70 mmHg

Time frame: 6 weeks and 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.