Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: September 2, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Type 1 Diabetes
Device: Closed loop
Device: Home glucose monitoring
Device: Insulin pump
Device: Continuous glucose monitor
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Jaeb Center for Health Research:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Adverse Events (Severe Hypoglycemia) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • CGM Mean Glucose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • CGM Measured Glucose Outcomes [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Include a series of glucose indices created from CGM measured glucose data, such as % glucose <=70 mg/dl, % glucose within target range of 71-180 mg/dl, % glucose >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 ] [ Designated as safety issue: No ]
  • BMI Percentile [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 71
Study Start Date: September 2010
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intensive Treatment
closed loop therapy (4-6 days), insulin pump (2 years), continuous glucose monitoring (2 years), home glucose monitoring (2 years)
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
Active Comparator: Standard Treatment
home glucose monitoring (2 years)
Device: Home glucose monitoring
Standard diabetes management using a home glucose meter.

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

Ages Eligible for Study:   6 Years to 45 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00891995

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80010
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06519
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Jaeb Center for Health Research
Investigators
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
  More Information

Publications:
Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00891995     History of Changes
Obsolete Identifiers: NCT00505206
Other Study ID Numbers: DirecNet 012 
Study First Received: April 30, 2009
Results First Received: January 11, 2016
Last Updated: September 2, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Jaeb Center for Health Research:
Type 1 Diabetes
Closed Loop Therapy
Continuous Glucose Monitor

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016