NCT00891995

Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 6 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if very tight blood glucose control from the onset of Type 1 Diabetes can preserve beta cell function. Study subjects will be randomly assigned to receive either standard diabetes management or intensive diabetes management, which involves several days of closed loop therapy followed by home use of a continuous glucose monitor and insulin pump.

Detailed description

The specific aim of this study is to determine if early restoration of metabolic control will improve C-peptide production compared to children receiving routine diabetes management and the secondary aim is to determine if allowing the islet cells to be less metabolically active will have an impact on the underlying autoimmune process. Following completion of the baseline procedures (Mixed Meal Tolerance Test and blood sample collection), participants are randomized to either the Standard Treatment Group or the Intensive Treatment Group which includes 4-6 days of inpatient closed loop therapy followed by outpatient use of an insulin pump and continuous glucose monitor for diabetes management. All subjects will be seen 7 times in the first year and 4 times in the second year for follow-up testing. Subjects who are still producing insulin after 2 years may be asked to return every 6 months for an additional 2 years.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Closed loop	Closed loop therapy for up to 4 to 6 days
DEVICE	Home glucose monitoring	Standard diabetes management using a home glucose meter.
DEVICE	Insulin pump	Insulin pump use for 2 years
DEVICE	Continuous glucose monitor	Continuous glucose monitor use for 2 years

Timeline

• Start date: 2010-09-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2009-05-01
• Last updated: 2016-12-30
• Results posted: 2016-10-27

Locations

5 sites across 1 country: United States