Trial Outcomes & Findings for Bionic Pancreas in Children With Hyperinsulinism and Post-Pancreatectomy Diabetes (NCT NCT03303196)
NCT ID: NCT03303196
Last Updated: 2020-10-27
Results Overview
Mean plasma glucose concentration, as measured by the Continuous glucose monitoring system (CGMS), during the final 2 days of the Bihormonal Bionic Pancreas Admission compared to the Standard Care Admission.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Days 2-3 of each admission
Results posted on
2020-10-27
Participant Flow
Participant milestones
| Measure |
Bihormonal Bionic Pancreas Admission
Four day inpatient admission where participants will have blood sugar managed by the Bihormonal Bionic Pancreas. Blood sugars will be monitored for safety by study staff.
|
Standard Care Admission
Four day inpatient admission where participants will have blood sugar managed by the participant's home-glucose control regimen. Blood sugars will be monitored for safety by study staff.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
|
Overall Study
Washout
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bionic Pancreas in Children With Hyperinsulinism and Post-Pancreatectomy Diabetes
Baseline characteristics by cohort
| Measure |
Sequential Admissions
n=10 Participants
Bihormonal bionic pancreas admission: Four day inpatient admission where participants will have blood sugar managed by the Bihormonal Bionic Pancreas. Blood sugars will be monitored for safety by study staff.
\*before or after\* Standard care admission: Four day inpatient admission where participants will have blood sugar managed by the participant's home-glucose control regimen. Blood sugars will be monitored for safety by study staff.
|
|---|---|
|
Age, Continuous
|
15.1 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
|
Mean Plasma Glucose Level
Bionic Pancreas Admission
|
8.3 mmmol/L
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Mean Plasma Glucose Level
Standard Care Admission
|
9.0 mmmol/L
STANDARD_DEVIATION 1.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: Days 2-3 of each admissionMean plasma glucose concentration, as measured by the Continuous glucose monitoring system (CGMS), during the final 2 days of the Bihormonal Bionic Pancreas Admission compared to the Standard Care Admission.
Outcome measures
| Measure |
Sequential Admissions
n=10 Participants
Bihormonal bionic pancreas admission: Four day inpatient admission where participants will have blood sugar managed by the Bihormonal Bionic Pancreas. Blood sugars will be monitored for safety by study staff.
\*before or after\* Standard care admission: Four day inpatient admission where participants will have blood sugar managed by the participant's home-glucose control regimen. Blood sugars will be monitored for safety by study staff.
|
|---|---|
|
Mean Plasma Glucose Level.
Bihormonal Bionic Pancreas Admission
|
149.666118 mg/dL
Standard Deviation 12.7998623
|
|
Mean Plasma Glucose Level.
Standard Care Admision
|
162.574753 mg/dL
Standard Deviation 32.2642656
|
Adverse Events
Bihormonal Bionic Pancreas Admission
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Standard Care Admission
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Bihormonal Bionic Pancreas Admission
n=5 participants at risk
Four day inpatient admission where participants will have blood sugar managed by the Bihormonal Bionic Pancreas. Blood sugars will be monitored for safety by study staff.
|
Standard Care Admission
n=5 participants at risk
Four day inpatient admission where participants will have blood sugar managed by the participant's home-glucose control regimen. Blood sugars will be monitored for safety by study staff.
|
|---|---|---|
|
Gastrointestinal disorders
Intermittent nasuea
|
40.0%
2/5 • Number of events 3 • Adverse event data was collected from the start of screening until the end of the last day of the subject's second admission. This time period ranged from 16 to 38 days, depending on how many days in between admissions they had.
|
60.0%
3/5 • Number of events 4 • Adverse event data was collected from the start of screening until the end of the last day of the subject's second admission. This time period ranged from 16 to 38 days, depending on how many days in between admissions they had.
|
|
Nervous system disorders
Headache
|
0.00%
0/5 • Adverse event data was collected from the start of screening until the end of the last day of the subject's second admission. This time period ranged from 16 to 38 days, depending on how many days in between admissions they had.
|
60.0%
3/5 • Number of events 3 • Adverse event data was collected from the start of screening until the end of the last day of the subject's second admission. This time period ranged from 16 to 38 days, depending on how many days in between admissions they had.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/5 • Adverse event data was collected from the start of screening until the end of the last day of the subject's second admission. This time period ranged from 16 to 38 days, depending on how many days in between admissions they had.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the start of screening until the end of the last day of the subject's second admission. This time period ranged from 16 to 38 days, depending on how many days in between admissions they had.
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/5 • Adverse event data was collected from the start of screening until the end of the last day of the subject's second admission. This time period ranged from 16 to 38 days, depending on how many days in between admissions they had.
|
20.0%
1/5 • Number of events 1 • Adverse event data was collected from the start of screening until the end of the last day of the subject's second admission. This time period ranged from 16 to 38 days, depending on how many days in between admissions they had.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place