NCT03262116

Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Humalog	Subjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin.
DRUG	Novolog	Subjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin.
DRUG	BC222 insulin lispro	Subjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin.
DEVICE	Bionic Pancreas	The insulin-only bionic pancreas will be used in all three arms of the study

Timeline

• Start date: 2019-03-19
• Primary completion: 2019-07-23
• Completion: 2019-07-23
• First posted: 2017-08-25
• Last updated: 2022-12-09
• Results posted: 2022-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study