Subjects will participate in three weeks of the bionic pancreas in the insulin-only configuration. Each week, subjects will use a different rapid acting insulin analog -- Humalog, Novolog, or BC222 insulin lispro -- in a randomized cross-over order.
The investigators hypothesize that differences in the PK characteristics of insulin analogs will lead to differences in glycemic outcomes when delivered by the insulin-only configuration of the bionic pancreas. Specifically, the investigators predict that insulin analogs that have faster absorption (numerically lower Tmax and/or T½max) and insulin analogs that have faster clearance (numerically lower terminal half-life) will result in lower mean glucose and/or a lower percentage of time in the hypoglycemic range. Up to 30 subjects will participate in three 7-day study arms using insulin lispro, insulin aspart, and BC222 lispro in the bionic pancreas in random order. The co-primary outcomes will be mean CGMG and fraction of time spent with CGMG \<54 mg/dl with comparisons made between arms for individual participants. Secondary analyses will include time in glycemic ranges (\<50, \<60, \<70, 70-120, 70-180, \>180, \>250 mg/dl), coefficient of variation, mean postprandial excursion (difference in CGMG from the time of meal announcement to the peak CGMG in the first 4 hours after the meal announcement) for both mixed meal challenges, number of symptomatic hypoglycemic events, grams of carbohydrate consumed to treat hypoglycemia, and TDD of insulin, between arms for individual subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Subjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin.
Subjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin.
Subjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin.
Massachusetts General Hospital
Boston, Massachusetts, United States
Average Continuous Glucose Monitor (CGM) Glucose
The average glucose achieved by the bionic pancreas as measured by the continuous glucose monitor during each arm
Time frame: 7 days
Percentage of Time Spent With CGM Glucose < 54 mg/dl
The amount of time the subject spent in the hypoglycemic range \< 54 mg/dl as measured by the continuous glucose monitor during each arm
Time frame: 7 days
Percentage of Time Spent Within Each of the Following Ranges:
The amount of time subject's spent in each of the listed glucose ranges as measured by the continuous glucose monitor during each bionic pancreas arm
Time frame: 7 days
Within Day Coefficient of Variation
A measure of dispersion of glucose values around the mean
Time frame: 7 days
Mean Post Prandial Excursion
Difference in CGMG from the beginning of the meal challenge to the peak CGMG in the 4 hours after the meal, for both mixed meal challenges.
Time frame: 7 days
Number of Symptomatic Hypoglycemic Events Per Day
The number of times subjects report experiencing symptoms of hypoglycemia during each bionic pancreas arm
Time frame: 7 days
Grams of Carbohydrates Consumed to Treat Hypoglycemia Per Day
The total amount of grams of carbohydrates subjects report having to take in for treatment of hypoglycemia
Time frame: 7 days
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The insulin-only bionic pancreas will be used in all three arms of the study
Total Daily Dose of Insulin
The average total amount of insulin delivered daily by the bionic pancreas during each bionic pancreas arm.
Time frame: 7 days