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

Primary Purpose

Type 1 Diabetes

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Closed loop
Home glucose monitoring
Insulin pump
Continuous glucose monitor
Sponsored by
Jaeb Center for Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Closed Loop Therapy, Continuous Glucose Monitor

Eligibility Criteria

6 Years - 45 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

  • Stanford University
  • Barbara Davis Center for Childhood Diabetes
  • Yale University
  • Indiana University
  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive Treatment

Standard Treatment

Arm Description

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

home glucose monitoring (2 years)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment
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.
HbA1c
Adverse Events (Severe Hypoglycemia)
CGM Mean Glucose
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.
Daily Insulin Dose
BMI Percentile

Full Information

First Posted
April 30, 2009
Last Updated
November 9, 2016
Sponsor
Jaeb Center for Health Research
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1. Study Identification

Unique Protocol Identification Number
NCT00891995
Brief Title
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Official Title
Effect of Metabolic Control at Onset of Diabetes on Progression of Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Terminated
Why Stopped
Primary outcome evaluation determined lack of treatment group difference
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaeb Center for Health Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 Diabetes, Closed Loop Therapy, Continuous Glucose Monitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intensive Treatment
Arm Type
Experimental
Arm Description
closed loop therapy (4-6 days), insulin pump (2 years), continuous glucose monitoring (2 years), home glucose monitoring (2 years)
Arm Title
Standard Treatment
Arm Type
Active Comparator
Arm Description
home glucose monitoring (2 years)
Intervention Type
Device
Intervention Name(s)
Closed loop
Intervention Description
Closed loop therapy for up to 4 to 6 days
Intervention Type
Device
Intervention Name(s)
Home glucose monitoring
Intervention Description
Standard diabetes management using a home glucose meter.
Intervention Type
Device
Intervention Name(s)
Insulin pump
Intervention Description
Insulin pump use for 2 years
Intervention Type
Device
Intervention Name(s)
Continuous glucose monitor
Intervention Description
Continuous glucose monitor use for 2 years
Primary Outcome Measure Information:
Title
C-peptide Average Area Under the Curve (AUC) in Response to a Mixed Meal at 1 Year Following Enrollment.
Description
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).
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
Secondary Outcome Measure Information:
Title
Peak C-peptide in Response to a Mixed Meal at 1 Year Following Enrollment
Time Frame
0 to 240 min post meal at 1 year MMTT
Title
Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT
Description
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.
Time Frame
0 to 240 min post meal at 1 year MMTT
Title
HbA1c
Time Frame
1 year
Title
Adverse Events (Severe Hypoglycemia)
Time Frame
1 year
Title
CGM Mean Glucose
Time Frame
1 year
Title
CGM Measured Glucose Outcomes
Description
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.
Time Frame
1 year
Title
Daily Insulin Dose
Time Frame
1 year
Title
BMI Percentile
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy W Beck, M.D., Ph.D.
Organizational Affiliation
Jaeb Center for Health Research
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jay S. Skyler, M.D., M.A.C.P.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Barbara Davis Center for Childhood Diabetes
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24130350
Citation
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.
Results Reference
background
PubMed Identifier
23570538
Citation
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.
Results Reference
result

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

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