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

This study has been terminated.
(Primary outcome evaluation determined lack of treatment group difference)
Sponsor:
Information provided by (Responsible Party):
Jaeb Center for Health Research
ClinicalTrials.gov Identifier:
NCT00891995
First received: April 30, 2009
Last updated: September 2, 2016
Last verified: September 2016
Results First Received: January 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 1 Diabetes
Interventions: Device: Closed loop
Device: Home glucose monitoring
Device: Insulin pump
Device: Continuous glucose monitor

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intensive Treatment The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and continuous glucose monitoring (CGM) in addition to standard monitoring with a home glucose meter for 2 years.
Standard Treatment The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.

Participant Flow:   Overall Study
    Intensive Treatment   Standard Treatment
STARTED   50   21 
COMPLETED   50   21 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only 48 participants in the intensive treatment group and 20 participants in the standard treatment group who show any positive autoantibody in the first year were included in the analyses.

Reporting Groups
  Description
Intensive 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.
Standard Treatment The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
Total Total of all reporting groups

Baseline Measures
   Intensive Treatment   Standard Treatment   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   20   68 
Age 
[Units: Participants]
     
<=18 years   46   19   65 
Between 18 and 65 years   2   1   3 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 12.7  (4.7)   14.7  (7.6)   13.3  (5.7) 
Gender 
[Units: Participants]
     
Female   17   7   24 
Male   31   13   44 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   42   18   60 
Black   1   0   1 
Hispanic or Latino   2   1   3 
More than one race   1   0   1 
Unknown   2   1   3 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   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 ]

3.  Secondary:   Incidence of the Loss of the 2 Hour Peak C-peptide < 0.2 Pmol/ml on a Semi-annual MMTT   [ Time Frame: 0 to 240 min post meal at 1 year MMTT ]

4.  Secondary:   HbA1c   [ Time Frame: 1 year ]

5.  Secondary:   Adverse Events (Severe Hypoglycemia)   [ Time Frame: 1 year ]

6.  Secondary:   CGM Mean Glucose   [ Time Frame: 1 year ]

7.  Secondary:   CGM Measured Glucose Outcomes   [ Time Frame: 1 year ]

8.  Secondary:   Daily Insulin Dose   [ Time Frame: 1 year ]

9.  Secondary:   BMI Percentile   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Katrina Ruedy
Organization: Jaeb Center for Health Research
phone: 8139758690
e-mail: kruedy@jaeb.org


Publications of Results:
Other Publications:

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00891995     History of Changes
Obsolete Identifiers: NCT00505206
Other Study ID Numbers: DirecNet 012
Study First Received: April 30, 2009
Results First Received: January 11, 2016
Last Updated: September 2, 2016
Health Authority: United States: Food and Drug Administration