NCT00891995

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2010

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

October 27, 2016

Completed
Last Updated

December 30, 2016

Status Verified

November 1, 2016

Enrollment Period

3.1 years

First QC Date

April 30, 2009

Results QC Date

January 11, 2016

Last Update Submit

November 9, 2016

Conditions

Type 1 Diabetes

Keywords

Type 1 DiabetesClosed Loop TherapyContinuous Glucose Monitor

Outcome Measures

Primary Outcomes (1)

  • C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.

    In the primary analysis of the 12-month Mixed-Meal Tolerance Test (MMTT) results, the geometric mean (95% C.I.) of C-peptide average AUC (=AUC/time) was 0.43 (0.34, 0.52) pmol/ml in the intensive treatment group and 0.52 (0.32, 0.75) pmol/ml in the usual care group (P=0.49).

    At baseline, MMTT data were collected at 0 and 90 min; at 12 months, MMTT data were collected at 0 to 240 min post meal

Secondary Outcomes (8)

  • Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment

    0 to 240 min post meal at 1 year MMTT

  • Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT

    0 to 240 min post meal at 1 year MMTT

  • HbA1c

    1 year

  • Adverse Events (Severe Hypoglycemia)

    1 year

  • CGM Mean Glucose

    1 year

  • +3 more secondary outcomes

Study Arms (2)

Intensive Treatment

EXPERIMENTAL

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

Device: Closed loopDevice: Home glucose monitoringDevice: Insulin pumpDevice: Continuous glucose monitor

Standard Treatment

ACTIVE COMPARATOR

home glucose monitoring (2 years)

Device: Home glucose monitoring

Interventions

Closed loopDEVICE

Closed loop therapy for up to 4 to 6 days

Intensive Treatment
Home glucose monitoringDEVICE

Standard diabetes management using a home glucose meter.

Intensive TreatmentStandard Treatment
Insulin pumpDEVICE

Insulin pump use for 2 years

Intensive Treatment
Continuous glucose monitorDEVICE

Continuous glucose monitor use for 2 years

Intensive Treatment

Eligibility Criteria

Age6 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Stanford University

Stanford, California, 94305, United States

Location

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80010, United States

Location

Yale University

New Haven, Connecticut, 06519, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

  • Buckingham B, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Tamborlane WV; Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group. Effectiveness of early intensive therapy on beta-cell preservation in type 1 diabetes. Diabetes Care. 2013 Dec;36(12):4030-5. doi: 10.2337/dc13-1074. Epub 2013 Oct 15.

    PMID: 24130350BACKGROUND

  • Diabetes Research in Children Network (DirecNet) Study Group; Type 1 Diabetes TrialNet Study Group; Buckingham BA, Beck RW, Ruedy KJ, Cheng P, Kollman C, Weinzimer SA, DiMeglio LA, Bremer AA, Slover R, Cantwell M. The effects of inpatient hybrid closed-loop therapy initiated within 1 week of type 1 diabetes diagnosis. Diabetes Technol Ther. 2013 May;15(5):401-8. doi: 10.1089/dia.2013.0002. Epub 2013 Apr 9.

    PMID: 23570538RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Glucose Self-MonitoringInsulin Infusion Systems

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineMonitoring, PhysiologicSelf-TestingSelf CareTherapeuticsInvestigative TechniquesDrug Delivery SystemsDrug TherapyInfusion PumpsEquipment and SuppliesArtificial OrgansSurgical Equipment

Results Point of Contact

Title
Katrina Ruedy
Organization
Jaeb Center for Health Research
kruedy@jaeb.org
8139758690

Study Officials

  • Roy W Beck, M.D., Ph.D.

    Jaeb Center for Health Research

    STUDY DIRECTOR

  • Jay S. Skyler, M.D., M.A.C.P.

    University of Miami

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 1, 2009

Study Start

September 1, 2010

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

December 30, 2016

Results First Posted

October 27, 2016

Record last verified: 2016-11

Locations

US(5)