Trial Outcomes & Findings for Artificial Pancreas Control System in an Outpatient Setting (NCT NCT01871870)
NCT ID: NCT01871870
Last Updated: 2015-05-15
Results Overview
This outcome will verify afferent signal transmittal from the Dexcom sensors to the algorithm and the efferent signal transmittal from the algorithm to the insulin and glucagon pumps. Outcome measure is the average number of sensor and/or pump telemetry failures per 28 hour study.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
28 hours
Results posted on
2015-05-15
Participant Flow
Participant milestones
| Measure |
Artificial Pancreas Control Software
Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone.
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|---|---|
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Overall Study
STARTED
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20
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Overall Study
COMPLETED
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11
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Overall Study
NOT COMPLETED
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9
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Reasons for withdrawal
| Measure |
Artificial Pancreas Control Software
Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone.
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|---|---|
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Overall Study
Hardware issues
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7
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Overall Study
hyperglycemia
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2
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Baseline Characteristics
Artificial Pancreas Control System in an Outpatient Setting
Baseline characteristics by cohort
| Measure |
Artificial Pancreas Control Software
n=20 Participants
Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=39 Participants
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Age, Categorical
Between 18 and 65 years
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20 Participants
n=39 Participants
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Age, Categorical
>=65 years
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0 Participants
n=39 Participants
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Age, Continuous
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37.4 years
STANDARD_DEVIATION 9.4 • n=39 Participants
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Sex: Female, Male
Female
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16 Participants
n=39 Participants
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Sex: Female, Male
Male
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4 Participants
n=39 Participants
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Region of Enrollment
United States
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20 participants
n=39 Participants
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PRIMARY outcome
Timeframe: 28 hoursThis outcome will verify afferent signal transmittal from the Dexcom sensors to the algorithm and the efferent signal transmittal from the algorithm to the insulin and glucagon pumps. Outcome measure is the average number of sensor and/or pump telemetry failures per 28 hour study.
Outcome measures
| Measure |
Artificial Pancreas Control Software
n=20 Participants
Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone.
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|---|---|
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Verification of the Automation and Telemetry Components
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16.5 failures
Standard Deviation 8
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SECONDARY outcome
Timeframe: 28 hoursAssessment of how accurately the algorithm controls glycemia in the subjects will be carried out using the mean deviation from the target blood glucose (mg/dL). Deviation is measured as algorithm controlled glucose level minus target glucose level.
Outcome measures
| Measure |
Artificial Pancreas Control Software
n=20 Participants
Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone.
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|---|---|
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Deviation From Target Blood Glucose
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91.35 mg/dl
Standard Deviation 91.41
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Adverse Events
Artificial Pancreas Control Software
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Artificial Pancreas Control Software
n=20 participants at risk
Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone.
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Gastrointestinal disorders
nausea
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5.0%
1/20 • Number of events 1
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place