The purpose of this pilot study is to establish that closed-loop insulin delivery with a target enchanted model predictive control (eMPC)/Health Monitoring System (HMS) algorithms with a trust index of the predicted glucose value is safe and effective, to analyze and learn to improve upon the accuracy of the predicted glucose values, and to collect efficacy data to inform a future larger study.
This is a feasibility study of an artificial pancreas (AP) system with our previously validated target eMPC and HMS algorithms, with the addition of a trust index of the predicted glucose value integrated into the portable Artificial Pancreas System (pAPS). The system will be evaluated on up to 20 subjects, with the goal of 10 subjects completing a 48-hour closed-loop session at one clinical site (William Sansum Diabetes Center). During the session subjects will bolus for all meals and snacks and perform a 45-minute walking session. The purpose of this pilot study is to establish that closed-loop insulin delivery with a target enchanted model predictive control (eMPC)/Health Monitoring System (HMS) algorithms with a trust index of the predicted glucose value is safe and effective, to analyze and learn to improve upon the accuracy of the predicted glucose values, and to collect efficacy data to inform a future larger study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Artificial Pancreas Device
William Sansum Diabetes Center
Santa Barbara, California, United States
Percent time within the target glucose range of 70-180 mg/dl overall as assessed by continuous glucose monitoring (CGM).
The primary endpoint for this pilot study will be time within the target glucose range of 70-180 mg/dl overall as assessed by continuous glucose monitoring (CGM), during closed-loop use, determining if the combination of eMPC and the assessment of trust index can provide safe and effective glucose control.
Time frame: 48 hours
Assessment of the trust index predictions vs. standard eMPC glucose predictions.
During closed-loop use, assessment of the trust index predictions vs. standard eMPC glucose predictions (frequency of moving away from nominal weights of predicted glucose).
Time frame: 48 hours
Frequency of hypoglycemia during closed-loop use.
Frequency of hypoglycemia during closed-loop use, defined as percent time glucose is below predefined thresholds of 70 mg/dl, 60 mg/dl and 50 mg/dL.
Time frame: 48 hours
Frequency of hyperglycemia during closed-loop use.
Frequency of hyperglycemia during closed-loop use, defined as percent time glucose is above predefined thresholds of 180 mg/dl, 250 mg/dl, and 300 mg/dL.
Time frame: 48 hours
Percent time within the target glucose range of 70-140 mg/dl during closed-loop use.
Percent time within the target glucose range of 70-140 mg/dl overall as assessed by continuous glucose monitoring (CGM), during closed-loop use.
Time frame: 48 hours
Percent time glucose is within range 70-150 mg/dl postprandial within 5 hours following meals, during closed-loop use.
Percent time glucose is within range 70-150 mg/dl postprandial within 5 hours following meals, during closed-loop use.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 48 hours
Standard Deviation and Coefficient of Variation of glucose values
To measure glycemic variability, the standard deviation and coefficient of variation of glucose values (as measured by continuous glucose monitoring) will be determined during the 48 hours of closed-loop use.
Time frame: 48 hours
Markers of hypo- and hyperglycemia
Markers of hypo- and hyperglycemia, to include LBGI (Low blood glucose index) and HBGI (High blood glucose index), during closed-loop use.
Time frame: 48 hours
Insulin Doses Given
Change in total daily doses and post prandial insulin doses given during the 48 hours of closed-loop use.
Time frame: 48 hours
Number of treatments given for hypoglycemia (defined as carbohydrates given for treatment of a documented or suspected low blood sugar), during the 48 hours of closed-loop use.
Treatments for hypoglycemia given during the 48 hours of closed-loop use. Hypoglycemia treatments may be given in response to alerts from the HMS, if blood glucose \< 70 mg/dL, or at the request of the subject or investigator.
Time frame: 48 hours
Number of alerts given by the HMS to prevent hypoglycemia
Number of alerts given by the HMS to prevent hypoglycemia during closed-loop use.
Time frame: 48 hours
Failure analysis of the devices/connectivity issues that may occur (# disconnects and device restarts).
Failure analysis of the devices/connectivity issues that may occur during closed-loop use. This includes number of CGM communication losses with 3 or more missed points, and number of times the entire system required a restart.
Time frame: 48 hours