The aim of this clinical study is to determine the feasibility, safety, and preliminary effectiveness of the Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP) system in pediatric subjects with type 1 diabetes in an ambulatory semi-supervised environment over a short duration of 3 days and 2 nights, or up to 60 hours.
The artificial pancreas platform employed under study is centered about the following four key innovations: 1) A zone model predictive control strategy that is at the same time very safe with respect to hypoglycemia, and can simultaneously and independently be tuned with respect to its response to hyperglycemia; 2) Zone control with diurnal blood-glucose target zones; 3) Models of insulin-glucose physiology and insulin on board; 4) A system for alarming and notification of impending hypoglycemia and technical malfunctions: the Health Monitoring System. These features have been evaluated in several clinical trials in adults with unannounced meals and exercise. The proposed study will evaluate enhancements to our previous system tailored for the special needs of pediatric subjects: 1) A control strategy with responses to hyperglycemia and hypoglycemia spanning wide ranges, as is typical with children; 2) The use of time-dependent zones specific for pediatric subjects; 3) The development of models for young children, capturing the greater physiologic variability, and ensuring cautious insulin delivery; 4) remote alarming and notification systems that are useful to parents.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Zone-Model Predictive Control Artificial Pancreas (ZMPC\_AP)
Yale University
New Haven, Connecticut, United States
Hypoglycemia Safety: Number of Participants With Blood Glucose (BG)) Readings < 50 Milligrams/Deciliter (mg/dL))
Number of participants with more than one confirmed BG \< 50 mg/dL
Time frame: 60 hours
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 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.
Time frame: 60 hours
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
Number 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
Time frame: 60 hours
Safety: Number of Participants Who Experienced an Adverse Event
Adverse events include seizure, loss of consciousness, severe hypoglycemia, diabetic ketoacidosis
Time frame: 60 hours
Mean Meter and Sensor Glucose Levels Milligram/Deciliter (mg/dL)
Mean meter and sensor glucose levels (mg/dL)
Time frame: 60 hours
Percent Sensor Glucose Time in Range (70-180 mg/dL)
Percentage 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
Time frame: 60 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Percent Sensor Glucose Time Below Range (<70 mg/dL)
Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is below 70 mg/dL
Time frame: 60 hours
Percent Sensor Glucose Time Above Range (>180 mg/dL)
Percentage 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
Time frame: 60 hours
Percent Sensor Glucose Time in Hypoglycemia (<60 mg/dL)
Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is below 60 mg/dL
Time frame: 60 hours
Percent Sensor Glucose Time in Hyperglycemia (>250 mg/dL)
Percentage 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
Time frame: 60 hours
Percent Time AP System Active
Percentage 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
Time frame: 60 hours