Diabetes Care Management Trial of Telemetric Monitoring

A Randomized Study Comparing Usual Diabetes Care Management to Telemetric Home-based Monitoring of Glucose and Blood Pressure in Patients With Diabetes (TELEGAP)

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

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.