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Trial record 1 of 1 for:    NCT01161862
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Integration of Continuous Glucose Monitoring Into a BiHormonal Closed-Loop Artificial Pancreas (CL2)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01161862
First Posted: July 14, 2010
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Massachusetts General Hospital
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Diabetes Research Foundation
The Leona M. and Harry B. Helmsley Charitable Trust
Information provided by (Responsible Party):
Edward R. Damiano, Boston University
Results First Submitted: October 31, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Diabetes Mellitus
Intervention: Device: Bi-hormonal (insulin and glucagon) artificial pancreas

  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
Twelve adult and twelve pediatric subjects with type 1 diabetes and no endogenous insulin secretion participated in two 51-h experiments. The protocol was approved by the Massachusetts General Hospital (MGH) and Boston University Human Research Committees

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Bi-hormonal Bionic Pancreas With Meal-priming Bolus The first meal-priming bolus was solely based on weight (0.05 U/kg), after which meal-priming boluses were automatically adapted by the control system online targeting 75% of the anticipated insulin needed in the first four hours after the start of the meal.
Bi-hormonal Bionic Pancreas With no Meal-priming Bolus Bi-hormonal bionic pancreas with no meal-priming bolus. The controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements

Participant Flow:   Overall Study
    Bi-hormonal Bionic Pancreas With Meal-priming Bolus   Bi-hormonal Bionic Pancreas With no Meal-priming Bolus
STARTED   12   12 
COMPLETED   12   12 
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.
No text entered.

Reporting Groups
  Description
Bi-hormonal Pancreas With Meal-priming Bolus An automatically adapting meal priming bolus was given by the controller at the time each meal was presented
Bi-hormonal Pancreas Without Meal-priming Bolus The insulin controller was entirely reactive to CGMG; there were no meal priming boluses and no meal announcements
Total Total of all reporting groups

Baseline Measures
   Bi-hormonal Pancreas With Meal-priming Bolus   Bi-hormonal Pancreas Without Meal-priming Bolus   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   12   24 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      6  50.0%      6  50.0%      12  50.0% 
Between 18 and 65 years      6  50.0%      5  41.7%      11  45.8% 
>=65 years      0   0.0%      1   8.3%      1   4.2% 
Age 
[Units: Years]
Mean (Standard Deviation)
 30  (17.7)   30.5  (19.0)   30  (18) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      7  58.3%      8  66.7%      15  62.5% 
Male      5  41.7%      4  33.3%      9  37.5% 
Region of Enrollment 
[Units: Participants]
     
United States   12   12   24 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Plasma Blood Glucose Achieved by the Bionic Pancreas (mg/dl)   [ Time Frame: 48 hours ]

2.  Secondary:   Percentage of Time Spent With Blood Glucose < 60 mg/dl   [ Time Frame: 48 hours ]

3.  Secondary:   Percentage of Time Spent With Blood Glucose <70 mg/dl   [ Time Frame: 48 hours ]

4.  Secondary:   Percentage of Time Spent With Blood Glucose 70-180 mg/dl   [ Time Frame: 48 hours ]

5.  Secondary:   Insulin Total Daily Dose   [ Time Frame: 48 hours ]

6.  Secondary:   Number of Carbohydrate Interventions for Hypoglycemia   [ Time Frame: 48 hours ]

7.  Secondary:   Number of Blood Glucose Events < 70 mg/dl   [ Time Frame: 48 hours ]

8.  Secondary:   Nadir Blood Glucose in Each Arm   [ Time Frame: 48 hours ]


  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: Edward R. Damiano
Organization: Department of Biomedical Engineering, Boston University, Boston, Massachusetts.
phone: (617) 353-9493
e-mail: edamiano@bu.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Edward R. Damiano, Boston University
ClinicalTrials.gov Identifier: NCT01161862     History of Changes
Other Study ID Numbers: H-29293
1R01DK085633-01 ( U.S. NIH Grant/Contract )
First Submitted: July 12, 2010
First Posted: July 14, 2010
Results First Submitted: October 31, 2016
Results First Posted: November 14, 2017
Last Update Posted: November 14, 2017