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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.
Age
6 - 45 years
Sex
ALL
Healthy Volunteers
No
Stanford University
Stanford, California, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
Indiana University
Indianapolis, Indiana, United States
Vanderbilt University
Nashville, Tennessee, United States
Start Date
September 1, 2010
Primary Completion Date
October 1, 2013
Completion Date
October 1, 2013
Last Updated
December 30, 2016
71
ACTUAL participants
Closed loop
DEVICE
Home glucose monitoring
DEVICE
Insulin pump
DEVICE
Continuous glucose monitor
DEVICE
Lead Sponsor
Jaeb Center for Health Research
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07455994