Clinical trial NCT00891995: Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Official title: Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Closed Loop Therapy
Continuous Glucose Monitor
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
First posted: 2009-05-01
Enrollment: 71
Sex: ALL
Minimum age (years): 6
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.
timeFrame: At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal
Secondary outcomes:
measure: Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment
timeFrame: 0 to 240 min post meal at 1 year MMTT
measure: Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT
timeFrame: 0 to 240 min post meal at 1 year MMTT
measure: HbA1c
timeFrame: 1 year
measure: Adverse Events (Severe Hypoglycemia)
timeFrame: 1 year
measure: CGM Mean Glucose
timeFrame: 1 year
measure: CGM Measured Glucose Outcomes
timeFrame: 1 year
measure: Daily Insulin Dose
timeFrame: 1 year
measure: BMI Percentile
timeFrame: 1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Jaeb Center for Health Research
name: Roy W Beck, M.D., Ph.D.
role: STUDY_DIRECTOR
affiliation: University of Miami
name: Jay S. Skyler, M.D., M.A.C.P.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.