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Trial record 91 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

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

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ClinicalTrials.gov Identifier: NCT00797823
Recruitment Status : Completed
First Posted : November 25, 2008
Results First Posted : September 26, 2011
Last Update Posted : October 7, 2011
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Oregon Health and Science University
Information provided by (Responsible Party):
W. Kenneth Ward, Legacy Health System

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Type 1 Diabetes
Interventions Drug: Insulin, Asp(B28)-
Drug: Glucagon
Drug: Placebo
Enrollment 14
Recruitment Details Patients were recruited from the Oregon Health and Science University (OHSU) outpatient clinics in Portland, Oregon.
Pre-assignment Details 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.
Arm/Group Title Insulin + Glucagon -> Insulin + Placebo) Insulin + Placebo -> Insulin + Glucagon Pilot
Hide Arm/Group Description 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). 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 studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
Period Title: Pilot Studies
Started 0 [1] 0 [1] 6
Completed 0 0 6
Not Completed 0 0 0
[1]
Not involved in pilot studies
Period Title: First Period (Initial Randomization)
Started 4 4 0 [1]
Completed 3 4 0
Not Completed 1 0 0
Reason Not Completed
Physician Decision             1             0             0
[1]
Pilot studies only performed during initial period.
Period Title: Second Period (Crossover)
Started 3 4 0
Completed 3 4 0
Not Completed 0 0 0
Arm/Group Title Insulin + Glucagon -> Insulin + Placebo) Insulin + Placebo -> Insulin + Glucagon Pilot Total
Hide Arm/Group Description 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). 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 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 of all reporting groups
Overall Number of Baseline Participants 4 4 6 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 6 participants 14 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
4
 100.0%
6
 100.0%
14
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 6 participants 14 participants
33.3  (10.5) 39.8  (10.7) 35.1  (17.4) 36.7  (13.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 6 participants 14 participants
Female
2
  50.0%
2
  50.0%
3
  50.0%
7
  50.0%
Male
2
  50.0%
2
  50.0%
3
  50.0%
7
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 6 participants 14 participants
4 4 6 14
1.Primary Outcome
Title Effectiveness of Closed Loop Diabetes Control
Hide Description Effectiveness of closed loop diabetes control will be measured by mean glucose.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined was per protocol.
Arm/Group Title Placebo Comparator: Insulin Alone Active Comparator: Insulin Plus Glucagon
Hide Arm/Group Description:
No glucagon given during closed loop control-insulin only
Insulin plus glucagon given (latter to prevent hypoglycemia) for closed loop control.
Overall Number of Participants Analyzed 8 13
Mean (Standard Error)
Unit of Measure: mg/dl
136.9  (5.0) 149.5  (5.5)
2.Secondary Outcome
Title Percent of Time Venous Blood Glucose <70 mg/dl
Hide Description [Not Specified]
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Comparator: Insulin Alone Active Comparator: Insulin Plus Glucagon
Hide Arm/Group Description:
No glucagon given during closed loop control-insulin only
Insulin plus glucagon given (latter to prevent hypoglycemia) for closed loop control.
Overall Number of Participants Analyzed 8 13
Mean (Standard Error)
Unit of Measure: percent of time
2.8  (0.67) 1.15  (0.41)
Time Frame Over 1 year for entire research period, and over the study period for each individual study.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Insulin + Glucagon -> Insulin + Placebo) Insulin + Placebo -> Insulin + Glucagon Pilot
Hide Arm/Group Description 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). 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 studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
All-Cause Mortality
Insulin + Glucagon -> Insulin + Placebo) Insulin + Placebo -> Insulin + Glucagon Pilot
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Insulin + Glucagon -> Insulin + Placebo) Insulin + Placebo -> Insulin + Glucagon Pilot
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/4 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Insulin + Glucagon -> Insulin + Placebo) Insulin + Placebo -> Insulin + Glucagon Pilot
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      4/4 (100.00%)      1/6 (16.67%)    
Endocrine disorders       
Severe Hypoglycemia  [1]  4/4 (100.00%)  55 4/4 (100.00%)  67 1/6 (16.67%)  1
Gastrointestinal disorders       
Nausea and vomiting * [2]  1/4 (25.00%)  1 0/4 (0.00%)  0 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Venous blood glucose < 60 mg/dl, requiring treatment with intravenous (IV) dextrose.
[2]
Nausea reported by patient (+/- vomiting), related to glucagon administration.
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: W Kenneth Ward MD
Organization: Legacy Health System
Phone: 503-413-5171
Responsible Party: W. Kenneth Ward, Legacy Health System
ClinicalTrials.gov Identifier: NCT00797823     History of Changes
Other Study ID Numbers: IRB4311
First Submitted: November 24, 2008
First Posted: November 25, 2008
Results First Submitted: June 24, 2011
Results First Posted: September 26, 2011
Last Update Posted: October 7, 2011