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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00891995
• Other study ID #: DirecNet 012
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: April 30, 2009
• Last updated: April 30, 2013
• Start date: September 2010
• Est. completion date: November 2015

Study information

• Verified date: November 2011
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00505206

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: November 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.
• Home glucose monitoring
Standard diabetes management using a home glucose meter.

Locations

Country	Name	City	State
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado
United States	Indiana University	Indianapolis	Indiana
United States	Vanderbilt University	Nashville	Tennessee
United States	Yale University	New Haven	Connecticut
United States	Stanford University	Stanford	California

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	C-peptide area under the curve in response to a mixed meal at 1 year following enrollment.		1 year	No
Secondary	incidence of the loss of the 2 hour peak C-peptide < 0.2 pmol/ml on a semi-annual MMTT		2 years	No
Secondary	HbA1c		1 year	No
Secondary	Severe hypoglycemic events		1 year	Yes
Secondary	Daily insulin dose		1 year	No