Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
NCT ID: NCT00891995
Last Updated: 2016-12-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
71 participants
INTERVENTIONAL
2010-09-30
2013-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intensive Treatment
closed loop therapy (4-6 days), insulin pump (2 years), continuous glucose monitoring (2 years), home glucose monitoring (2 years)
Closed loop
Closed loop therapy for up to 4 to 6 days
Home glucose monitoring
Standard diabetes management using a home glucose meter.
Insulin pump
Insulin pump use for 2 years
Continuous glucose monitor
Continuous glucose monitor use for 2 years
Standard Treatment
home glucose monitoring (2 years)
Home glucose monitoring
Standard diabetes management using a home glucose meter.
Interventions
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Closed loop
Closed loop therapy for up to 4 to 6 days
Home glucose monitoring
Standard diabetes management using a home glucose meter.
Insulin pump
Insulin pump use for 2 years
Continuous glucose monitor
Continuous glucose monitor use for 2 years
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
6 Years
45 Years
ALL
No
Sponsors
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Jaeb Center for Health Research
OTHER
Responsible Party
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Principal Investigators
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Roy W Beck, M.D., Ph.D.
Role: STUDY_DIRECTOR
Jaeb Center for Health Research
Jay S. Skyler, M.D., M.A.C.P.
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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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
Countries
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References
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Buckingham B, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Tamborlane WV; Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group. Effectiveness of early intensive therapy on beta-cell preservation in type 1 diabetes. Diabetes Care. 2013 Dec;36(12):4030-5. doi: 10.2337/dc13-1074. Epub 2013 Oct 15.
Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group; Buckingham BA, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Cantwell M. The effects of inpatient hybrid closed-loop therapy initiated within 1 week of type 1 diabetes diagnosis. Diabetes Technol Ther. 2013 May;15(5):401-8. doi: 10.1089/dia.2013.0002. Epub 2013 Apr 9.
Other Identifiers
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DirecNet 012
Identifier Type: -
Identifier Source: org_study_id
NCT00505206
Identifier Type: -
Identifier Source: nct_alias