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Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes

This study has been terminated.
(Primary outcome evaluation determined lack of treatment group difference)
Sponsor:
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00891995
First received: April 30, 2009
Last updated: November 9, 2016
Last verified: November 2016

April 30, 2009
November 9, 2016
September 2010
October 2013   (Final data collection date for primary outcome measure)
C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment. [ Time Frame: 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 ]
In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49).
C-peptide area under the curve in response to a mixed meal at 1 year following enrollment. [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00891995 on ClinicalTrials.gov Archive Site
  • Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment [ Time Frame: 0 to 240 min post meal at 1 year MMTT ]
  • Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT [ Time Frame: 0 to 240 min post meal at 1 year MMTT ]
    Outcome measure in the table is the incidence of 2 hour peak C-peptide>=0.2 pmol/ml. Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported.
  • HbA1c [ Time Frame: 1 year ]
  • Adverse Events (Severe Hypoglycemia) [ Time Frame: 1 year ]
  • CGM Mean Glucose [ Time Frame: 1 year ]
  • CGM Measured Glucose Outcomes [ Time Frame: 1 year ]
    Include a series of glucose indices created from CGM measured glucose data, such as % time with glucose values <=70 mg/dl, % time with glucose values within target range of 71-180 mg/dl, % time with glucose values >180 mg/dl, and glucose variability as measured by coefficient of variation. These indices were calculated by giving equal weight to each of the 24 h of the day. At least 24 h of CGM data were required for calculating these indices.
  • Daily Insulin Dose [ Time Frame: 1 year ]
  • BMI Percentile [ Time Frame: 1 year ]
  • incidence of the loss of the 2 hour peak C-peptide < 0.2 pmol/ml on a semi-annual MMTT [ Time Frame: 2 years ]
  • HbA1c [ Time Frame: 1 year ]
  • Severe hypoglycemic events [ Time Frame: 1 year ]
  • Daily Insulin Dose [ Time Frame: 1 year ]
Not Provided
Not Provided
 
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
  • Device: Closed loop
    Closed loop therapy for up to 4 to 6 days
  • Device: Home glucose monitoring
    Standard diabetes management using a home glucose meter.
  • Device: Insulin pump
    Insulin pump use for 2 years
  • Device: Continuous glucose monitor
    Continuous glucose monitor use for 2 years
  • Experimental: Intensive Treatment
    closed loop therapy (4-6 days), insulin pump (2 years), continuous glucose monitoring (2 years), home glucose monitoring (2 years)
    Interventions:
    • Device: Closed loop
    • Device: Home glucose monitoring
    • Device: Insulin pump
    • Device: Continuous glucose monitor
  • Active Comparator: Standard Treatment
    home glucose monitoring (2 years)
    Intervention: Device: Home glucose monitoring

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
71
October 2013
October 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
6 Years to 45 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00891995
DirecNet 012
Yes
Not Provided
Not Provided
Not Provided
Jaeb Center for Health Research
Jaeb Center for Health Research
Not Provided
Study Director: Roy W Beck, M.D., Ph.D. Jaeb Center for Health Research
Principal Investigator: Jay S. Skyler, M.D., M.A.C.P. University of Miami
Jaeb Center for Health Research
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP