Status:
TERMINATED
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Lead Sponsor:
Jaeb Center for Health Research
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
6-45 years
Phase:
PHASE2
PHASE3
Brief 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 eith...
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 ...
Eligibility Criteria
Inclusion
- Age 6.0 to \<46.0 years
- Diagnosis of type 1 diabetes with initiation of insulin therapy within past 7 days (day 1 being the first day of insulin therapy)
- If participant is female with reproductive potential, willing to avoid pregnancy and pregnancy test negative.
- Willing to accept randomization to either the intensive diabetes management group or the standard care group.
- Willing to complete the planned 2 years of follow-up.
- Able to electronically transmit data monthly.
- Investigator believes that the participant (and parent/guardian for children) understands and agrees to comply with the study protocol and is capable of undertaking all necessary testing.
Exclusion
- Currently pregnant or lactating, or anticipate getting pregnant in the next one year.
- Currently anemic (hematocrit level will be obtained at the screening visit).
- Chronic use of systemic steroids or other noninsulin pharmaceuticals that might affect glycemic control or the presence of a disease that is likely to be treated with such medications during the first two years of the study.
- Complicating medical issues that might interfere with study conduct.
- Inpatient psychiatric treatment in the past 6 months (if the participant is a minor, for either the participant or the participant's primary care giver).
- Currently participating in another type 1 diabetes treatment study, including an intervention trial for treatment of diabetic ketoacidosis.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00891995
Start Date
September 1 2010
End Date
October 1 2013
Last Update
December 30 2016
Active Locations (5)
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1
Stanford University
Stanford, California, United States, 94305
2
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80010
3
Yale University
New Haven, Connecticut, United States, 06519
4
Indiana University
Indianapolis, Indiana, United States, 46202