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



Status:Archived
Conditions:Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:September 2010
End Date:May 2015

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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.


We found this trial at
5
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Denver, CO
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Stanford, CA
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Ventura, California 93003
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