Diabetes Care Management Trial of Telemetric Monitoring

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: Telemonitoring Device

• Registration Number: NCT01775878
• Lead Sponsor: Kaiser Permanente

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2013-01
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-23
• Last Update Submitted: 2013-01-23
• Study First Posted: 2013-01-25
• Last Update Posted: 2013-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemonitoring Device	Telemonitoring Device	Patients in this arm received a telemonitoring device installed in their homes

Primary Outcome Measures

Name	Time	Method
Fructosamine	6 weeks	Change from baseline to 6 weeks in serum fructosamine levels
glycosylated hemoglobin	6 months	change from baseline to 6 months in serum HbA1c levels

Secondary Outcome Measures

Name	Time	Method
blood pressure	6 weeks and 6 months	goal of systolic \< 130 mmHg and diastolic \< 70 mmHg