Diabetes Care Management Trial of Telemetric Monitoring
TELEGAP
A Randomized Study Comparing Usual Diabetes Care Management to Telemetric Home-based Monitoring of Glucose and Blood Pressure in Patients With Diabetes (TELEGAP)
1 other identifier
interventional
254
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started May 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 23, 2013
CompletedFirst Posted
Study publicly available on registry
January 25, 2013
CompletedJanuary 25, 2013
January 1, 2013
1.7 years
January 23, 2013
January 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fructosamine
Change from baseline to 6 weeks in serum fructosamine levels
6 weeks
glycosylated hemoglobin
change from baseline to 6 months in serum HbA1c levels
6 months
Secondary Outcomes (1)
blood pressure
6 weeks and 6 months
Study Arms (2)
Usual Care
NO INTERVENTIONThis arm received usual care from the diabetes care managers
Telemonitoring Device
EXPERIMENTALPatients in this arm received a telemonitoring device installed in their homes
Interventions
Telemonitoring device was installed in patients' homes
Eligibility Criteria
You may qualify if:
- 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%.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kaiser Permanentelead
- Samsung Electronicscollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jerry Minkoff, MD
Kaiser Permanente
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2013
First Posted
January 25, 2013
Study Start
May 1, 2009
Primary Completion
January 1, 2011
Study Completion
January 1, 2011
Last Updated
January 25, 2013
Record last verified: 2013-01