Trial Outcomes & Findings for Yale-Harvard Hotel-based Closed-Loop Studies in Children (HY-GRAID) (NCT NCT04255381)
NCT ID: NCT04255381
Last Updated: 2022-06-01
Results Overview
Number of participants with more than one confirmed BG \< 50 mg/dL
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
60 hours
Results posted on
2022-06-01
Participant Flow
Participant milestones
| Measure |
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Use Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system
Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)
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|---|---|
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Overall Study
STARTED
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20
|
|
Overall Study
COMPLETED
|
20
|
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Yale-Harvard Hotel-based Closed-Loop Studies in Children (HY-GRAID)
Baseline characteristics by cohort
| Measure |
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
n=20 Participants
Use Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system
Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)
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|---|---|
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Age, Continuous
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11.3 years
STANDARD_DEVIATION 3.6 • n=5 Participants
|
|
Sex: Female, Male
Female
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8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 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
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
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|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Duration of Type I Diabetes
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5.0 years
STANDARD_DEVIATION 3.2 • n=5 Participants
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|
Baseline A1c
|
7.6 percentage of HbA1c
STANDARD_DEVIATION 0.9 • n=5 Participants
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PRIMARY outcome
Timeframe: 60 hoursNumber of participants with more than one confirmed BG \< 50 mg/dL
Outcome measures
| Measure |
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
n=20 Participants
Use Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system
Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)
|
|---|---|
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Hypoglycemia Safety: Number of Participants With Blood Glucose (BG)) Readings < 50 Milligrams/Deciliter (mg/dL))
No more than one confirmed BG < 50 mg/dL
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19 Participants
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|
Hypoglycemia Safety: Number of Participants With Blood Glucose (BG)) Readings < 50 Milligrams/Deciliter (mg/dL))
More than one confirmed BG < 50 mg/dL
|
1 Participants
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PRIMARY outcome
Timeframe: 60 hoursNo more than two confirmed BG ≥ 300 mg/dL longer than 2 hours, and no BG ≥ 400 mg/dL, unless determined to be from an infusion site failure.
Outcome measures
| Measure |
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
n=20 Participants
Use Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system
Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)
|
|---|---|
|
Hyperglycemia Safety: Number of Participants With More Than Two Blood Glucose (BG) Readings > 300 mg/dL Longer Than 2 Hour or Any BG 400 > Milligrams/Deciliter (mg/dL))
No more than 2 confirmed BG≥300 mg/dL > 2 hours and no BG≥400 mg/dL not due to infusion site failure
|
19 Participants
|
|
Hyperglycemia Safety: Number of Participants With More Than Two Blood Glucose (BG) Readings > 300 mg/dL Longer Than 2 Hour or Any BG 400 > Milligrams/Deciliter (mg/dL))
More than 2 two confirmed BG ≥ 300 mg/dL >2 hours or BG ≥ 400 mg/dL not due to infusion site failure
|
1 Participants
|
PRIMARY outcome
Timeframe: 60 hoursNumber of participants with blood ketone level \> 1.0 mmol/l for longer than 2 hours, and no blood ketone level \>3.0 mmol/L, unless determined to be from an infusion site. failure
Outcome measures
| Measure |
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
n=20 Participants
Use Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system
Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)
|
|---|---|
|
Blood Ketone Safety: Number of Participants With Blood Ketone Levels > 1.0 mmol/l for Longer Than 2 Hours or Any Ketone Level> 3.0 mmol/l
blood ketone levels > 1.0 mmol/l for longer than 2 hours
|
0 Participants
|
|
Blood Ketone Safety: Number of Participants With Blood Ketone Levels > 1.0 mmol/l for Longer Than 2 Hours or Any Ketone Level> 3.0 mmol/l
blood ketone levels > 3.0 mmol/l
|
0 Participants
|
|
Blood Ketone Safety: Number of Participants With Blood Ketone Levels > 1.0 mmol/l for Longer Than 2 Hours or Any Ketone Level> 3.0 mmol/l
blood ketone levels < 1.0 mmol/l for longer than 2 hours or blood ketone levels < 3.0 mmol/l
|
20 Participants
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PRIMARY outcome
Timeframe: 60 hoursAdverse events include seizure, loss of consciousness, severe hypoglycemia, diabetic ketoacidosis
Outcome measures
| Measure |
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
n=20 Participants
Use Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system
Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)
|
|---|---|
|
Safety: Number of Participants Who Experienced an Adverse Event
seizures
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0 Participants
|
|
Safety: Number of Participants Who Experienced an Adverse Event
loss of consciousness
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0 Participants
|
|
Safety: Number of Participants Who Experienced an Adverse Event
severe hypoglycemia
|
0 Participants
|
|
Safety: Number of Participants Who Experienced an Adverse Event
diabetic ketoacidosis
|
0 Participants
|
|
Safety: Number of Participants Who Experienced an Adverse Event
no adverse event
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20 Participants
|
SECONDARY outcome
Timeframe: 60 hoursMean meter and sensor glucose levels (mg/dL)
Outcome measures
| Measure |
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
n=20 Participants
Use Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system
Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)
|
|---|---|
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Mean Meter and Sensor Glucose Levels Milligram/Deciliter (mg/dL)
Sensor glucose
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172 mg/dL
Standard Deviation 26
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|
Mean Meter and Sensor Glucose Levels Milligram/Deciliter (mg/dL)
Meter blood glucose
|
161.4 mg/dL
Standard Deviation 39.8
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SECONDARY outcome
Timeframe: 60 hoursPercentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is between 70-180 mg/dL
Outcome measures
| Measure |
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
n=20 Participants
Use Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system
Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)
|
|---|---|
|
Percent Sensor Glucose Time in Range (70-180 mg/dL)
|
63.5 percentage of time
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: 60 hoursPercentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is below 70 mg/dL
Outcome measures
| Measure |
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
n=20 Participants
Use Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system
Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)
|
|---|---|
|
Percent Sensor Glucose Time Below Range (<70 mg/dL)
|
1.8 percentage of time
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: 60 hoursPercentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is greater than 180 mg/dL
Outcome measures
| Measure |
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
n=20 Participants
Use Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system
Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)
|
|---|---|
|
Percent Sensor Glucose Time Above Range (>180 mg/dL)
|
37.4 percentage of time
Standard Deviation 14.8
|
SECONDARY outcome
Timeframe: 60 hoursPercentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is below 60 mg/dL
Outcome measures
| Measure |
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
n=20 Participants
Use Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system
Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)
|
|---|---|
|
Percent Sensor Glucose Time in Hypoglycemia (<60 mg/dL)
|
0.6 percentage of time
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 60 hoursPercentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is greater than 250 mg/dL
Outcome measures
| Measure |
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
n=20 Participants
Use Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system
Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)
|
|---|---|
|
Percent Sensor Glucose Time in Hyperglycemia (>250 mg/dL)
|
12.1 percentage of time
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: 60 hoursPercentage of time, over the whole evaluation period, during which the sensor and pump are determined to be wirelessly connected and communicating with each other, based on duration of alert and error messages indicated by the system
Outcome measures
| Measure |
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
n=20 Participants
Use Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system
Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)
|
|---|---|
|
Percent Time AP System Active
|
92.7 percentage of time
Standard Deviation 7.0
|
Adverse Events
Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place