Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes - Full Text View

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00891995

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:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 1

Drug Information available for: Insulin human Dextrose

U.S. FDA Resources

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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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, Miller School of Medicine

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:	December 2, 2011
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 May 22, 2012