Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone

This study has been completed.
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Oregon Health and Science University
Information provided by (Responsible Party):
W. Kenneth Ward, Legacy Health System
ClinicalTrials.gov Identifier:
NCT00797823
First received: November 24, 2008
Last updated: October 4, 2011
Last verified: August 2009
Results First Received: June 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Type 1 Diabetes
Interventions: Drug: Insulin, Asp(B28)-
Drug: Glucagon
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited from the Oregon Health and Science University (OHSU) outpatient clinics in Portland, Oregon.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 22 studies in 14 subjects were performed. 6 subjects participated in 7 9-hour pilot studies, 6 with insulin and glucagon and 1 with insulin + placebo to assess the safety of the protocol. 8 subjects then underwent 2 interventional studies each for a total of 16 studies, one with insulin and placebo and one with insulin and glucagon.

Reporting Groups
  Description
Insulin + Glucagon -> Insulin + Placebo) This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
Insulin + Placebo -> Insulin + Glucagon This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
Pilot Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.

Participant Flow for 3 periods

Period 1:   Pilot Studies
    Insulin + Glucagon -> Insulin + Placebo)     Insulin + Placebo -> Insulin + Glucagon     Pilot  
STARTED     0 [1]   0 [1]   6  
COMPLETED     0     0     6  
NOT COMPLETED     0     0     0  
[1] Not involved in pilot studies

Period 2:   First Period (Initial Randomization)
    Insulin + Glucagon -> Insulin + Placebo)     Insulin + Placebo -> Insulin + Glucagon     Pilot  
STARTED     4     4     0 [1]
COMPLETED     3     4     0  
NOT COMPLETED     1     0     0  
Physician Decision                 1                 0                 0  
[1] Pilot studies only performed during initial period.

Period 3:   Second Period (Crossover)
    Insulin + Glucagon -> Insulin + Placebo)     Insulin + Placebo -> Insulin + Glucagon     Pilot  
STARTED     3     4     0  
COMPLETED     3     4     0  
NOT COMPLETED     0     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
Insulin + Glucagon -> Insulin + Placebo) This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
Insulin + Placebo -> Insulin + Glucagon This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
Pilot Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
Total Total of all reporting groups

Baseline Measures
    Insulin + Glucagon -> Insulin + Placebo)     Insulin + Placebo -> Insulin + Glucagon     Pilot     Total  
Number of Participants  
[units: participants]
  4     4     6     14  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     4     4     6     14  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  33.3  ± 10.5     39.8  ± 10.7     35.1  ± 17.4     36.7  ± 13.7  
Gender  
[units: participants]
       
Female     2     2     3     7  
Male     2     2     3     7  
Region of Enrollment  
[units: participants]
       
United States     4     4     6     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Effectiveness of Closed Loop Diabetes Control   [ Time Frame: 1 year ]

2.  Secondary:   Percent of Time Venous Blood Glucose <70 mg/dl   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: W Kenneth Ward MD
Organization: Legacy Health System
phone: 503-413-5171
e-mail: wardk@ohsu.edu


No publications provided


Responsible Party: W. Kenneth Ward, Legacy Health System
ClinicalTrials.gov Identifier: NCT00797823     History of Changes
Other Study ID Numbers: IRB4311
Study First Received: November 24, 2008
Results First Received: June 24, 2011
Last Updated: October 4, 2011
Health Authority: United States: Food and Drug Administration