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Type 1 DiabetesPhase 2/3NCT00891995

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

A Phase 2/3 study testing Closed loop, Home glucose monitoring and Insulin pump in people with Type 1 Diabetes, run by Jaeb Center for Health Research at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 6 to 45 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Closed loop, Home glucose monitoring and Insulin pump
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
5 sitesUnited States
Study dates
Sep 2010to Oct 2013
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Barbara Davis Center for Childhood Diabetes

    Aurora, Colorado, 80010

  • Indiana University

    Indianapolis, Indiana, 46202

  • Vanderbilt University

    Nashville, Tennessee, 37232

  • Yale University

    New Haven, Connecticut, 06519

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

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.

Read the 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.

Conditions
Type 1 Diabetes
Being tested
Closed loop, Home glucose monitoring, Insulin pump, Continuous glucose monitor
Keywords
Type 1 Diabetes, Closed Loop Therapy, Continuous Glucose Monitor
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Closed loopDevice

    Closed loop therapy for up to 4 to 6 days

  • Home glucose monitoringDevice

    Standard diabetes management using a home glucose meter.

  • Insulin pumpDevice

    Insulin pump use for 2 years

  • Continuous glucose monitorDevice

    Continuous glucose monitor use for 2 years

Study groups in NCT00891995
Study groupRoleWhat they receive
Intensive TreatmentExperimentalclosed loop therapy (4-6 days), insulin pump (2 years), continuous glucose monitoring (2 years), home glucose monitoring (2 years)
Receives: Device: Closed loop; Device: Home glucose monitoring; Device: Insulin pump; Device: Continuous glucose monitor
Standard TreatmentActive comparatorhome glucose monitoring (2 years)
Receives: Device: Home glucose monitoring

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)

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

    Measured: 0 to 240 min post meal at 1 year MMTT

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

    Outcome measure in the table is the incidence of 2 hour peak C-peptide>=0.2 pmol/ml. Since the formal clinical trial stopped at 12 months due to lack of efficiency (later follow-up were used to collect data for secondary analyses by pooling the two groups), only the outcome at 12 months are reported.

    Measured: 0 to 240 min post meal at 1 year MMTT

  3. HbA1c

    Measured: 1 year

  4. Adverse Events (Severe Hypoglycemia)

    Measured: 1 year

  5. CGM Mean Glucose

    Measured: 1 year

  6. CGM Measured Glucose Outcomes

    Include a series of glucose indices created from CGM measured glucose data, such as % time with glucose values <=70 mg/dl, % time with glucose values within target range of 71-180 mg/dl, % time with glucose values >180 mg/dl, and glucose variability as measured by coefficient of variation. These indices were calculated by giving equal weight to each of the 24 h of the day. At least 24 h of CGM data were required for calculating these indices.

    Measured: 1 year

  7. Daily Insulin Dose

    Measured: 1 year

  8. BMI Percentile

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2009 (estimated)
  2. Study startSep 2010
  3. Primary completionOct 2013
  4. Study completionOct 2013

Why it stopped: Primary outcome evaluation determined lack of treatment group difference

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00891995
Sponsor's protocol ID
DirecNet 012
Status last verified
Nov 2016
First submitted
30 Apr 2009
Last updated
30 Dec 2016
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24130350

  • 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.

    PubMed 23570538

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Closed loop, Home glucose monitoring and Insulin pump in people with Type 1 Diabetes, run by Jaeb Center for Health Research at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment. (time frame: 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00891995, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2016.

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