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

Jaeb Center for Health Research

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Type 1 Diabetes

Treatments: Device: Closed loop; Device: Insulin pump; Device: Home glucose monitoring; Device: Continuous glucose monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT00891995

DirecNet 012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 patients

Sex: All

Ages: 6 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 2 patient groups

Intensive Treatment

Experimental group

Description:

closed loop therapy (4-6 days), insulin pump (2 years), continuous glucose monitoring (2 years), home glucose monitoring (2 years)

Treatment:

Device: Continuous glucose monitor

Device: Insulin pump

Device: Home glucose monitoring

Device: Closed loop

Standard Treatment

Active Comparator group

Description:

home glucose monitoring (2 years)

Treatment:

Device: Home glucose monitoring