Type 1 Diabetes Clinical Trial
Official title:
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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