This trial is active, not recruiting.

Condition type 1 diabetes
Treatments closed loop therapy followed by use of insulin pump/cgm, home glucose monitoring
Phase phase 2/phase 3
Sponsor Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date September 2010
End date November 2013
Trial size 72 participants
Trial identifier NCT00891995, DirecNet 012, NCT00505206


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose 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.
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)
The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
home glucose monitoring
Standard diabetes management using a home glucose meter.

Primary Outcomes

C-peptide area under the curve in response to a mixed meal at 1 year following enrollment.
time frame: 1 year

Secondary Outcomes

incidence of the loss of the 2 hour peak C-peptide < 0.2 pmol/ml on a semi-annual MMTT
time frame: 2 years
time frame: 1 year
Severe hypoglycemic events
time frame: 1 year
Daily insulin dose
time frame: 1 year

Eligibility Criteria

Male or female participants from 6 years up to 45 years old.

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.

Additional Information

Official title Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Principal investigator Jay S. Skyler, M.D., M.A.C.P.
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2013.
Information provided to ClinicalTrials.gov by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).