NCT03565666

The Insulin-Only Bionic Pancreas Bridging Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The iLet is a closed-loop delivery system that can be used in insulin-only, bihormonal, or glucagon-only configurations. Previous studies have utilized a phone-based bionic pancreas. The iLet consists of a touchscreen-enabled, menu-driven user interface and an onboard microprocessor that provides a comprehensive and standalone platform, which allows the iLet to operate independently of smartphones or other devices and without the need for internet support during routine operation. This is a multicenter study of adult participants with type 1 diabetes, who will manage their diabetes with the iLet bionic pancreas compared to usual care.

Detailed description

This study will serve as a transitional study, bridging to larger and longer outpatient pivotal studies using the insulin-only configuration of the bionic pancreas. The Adult RCT Period will consist of a multi-center, three-period, random-order, cross-over, feasibility study in 36 adult participants ≥ 18 years old with T1D. Insulin therapy for each participant will be administered (i) using the iLet in the insulin-only configuration and the insulin analog that they use for their usual care (either Humalog or Novolog) for 7 days, (ii) in another period using the iLet in the insulin-only configuration with faster insulin aspart (Fiasp) for 7 days (iii) in a third period using the participant's own usual care (UC) for 7 days. All three experimental periods will be followed by round-the-clock, remote, telemetric monitoring for hyperglycemia (\> 300 mg/dl for ≥ 90 minutes) and hypoglycemia (\< 50 mg/dl for ≥ 15 minutes). Half the subjects enrolled were expected to manage their diabetes with MDI and the other half with insulin pumps in their UC. An implantable Eversense CGM will also be placed in half the study participants for a CGM comparison.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog	iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
DRUG	iLet Bionic Pancreas insulin-only configuration with Fiasp	iLet Bionic Pancreas insulin-only configuration with Fiasp (faster insulin aspart)
OTHER	Usual care	Usual care

Timeline

• Start date: 2018-07-09
• Primary completion: 2018-11-19
• Completion: 2018-11-19
• First posted: 2018-06-21
• Last updated: 2019-09-04
• Results posted: 2019-09-04

Locations

3 sites across 1 country: United States

Regulatory

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