Diabetes Care Management Trial of Telemetric Monitoring (TELEGAP)

Kaiser Permanente

Status: Completed

Conditions: Diabetes

Treatments: Device: Telemonitoring Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01775878

CN-08JMink-01

Details and patient eligibility

About

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

Enrollment: 254 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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254 participants in 2 patient groups

Usual Care

No Intervention group

Description:

This arm received usual care from the diabetes care managers

Telemonitoring Device

Experimental group

Description:

Patients in this arm received a telemonitoring device installed in their homes

Treatment:

Device: Telemonitoring Device