Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Stopped early · Phase 2/Phase 3
Conditions studied: Type 1 Diabetes
In brief
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.
Key facts
- Study ID
- NCT00891995
- Run by
- Jaeb Center for Health Research
- People needed
- 71
- Starts
- 2010-09-01
- Expected to finish
- 2013-10-01
- Last updated by the study team
- 2016-12-30
Who can join
Age: 6 and older, up to 45. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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