Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00891995
First received: April 30, 2009
Last updated: April 30, 2013
Last verified: November 2011
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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 therapy followed by use of insulin pump/CGM Device: Home glucose monitoring |
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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Primary Outcome Measures:
- C-peptide area under the curve in response to a mixed meal at 1 year following enrollment. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- incidence of the loss of the 2 hour peak C-peptide < 0.2 pmol/ml on a semi-annual MMTT [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- HbA1c [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Severe hypoglycemic events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Daily insulin dose [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 72 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Intensive Treatment
The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
|
Device: Closed loop therapy followed by use of insulin pump/CGM
Closed loop therapy for up to 4 to 6 days followed by 2 years of intense management using an insulin pump and continuous glucose monitor.
|
|
Active Comparator: Standard Treatment
The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 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 |
| 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
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
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
No publications provided
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00891995 History of Changes |
| Obsolete Identifiers: | NCT00505206 |
| Other Study ID Numbers: | DirecNet 012 |
| Study First Received: | April 30, 2009 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
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 Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013