Diabetes Care Management Trial of Telemetric Monitoring

Diabetes Clinical Trial

— TELEGAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775878
• Other study ID #: CN-08JMink-01
• Status: Completed
• Phase: N/A
• First received: January 23, 2013
• Last updated: January 23, 2013
• Start date: May 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2013
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Device:
• Telemonitoring Device
Telemonitoring device was installed in patients' homes

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Samsung Electronics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fructosamine	Change from baseline to 6 weeks in serum fructosamine levels	6 weeks
Primary	glycosylated hemoglobin	change from baseline to 6 months in serum HbA1c levels	6 months
Secondary	blood pressure	goal of systolic < 130 mmHg and diastolic < 70 mmHg	6 weeks and 6 months