CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04112069
NCT04112069N/ACompleted

The Insulin-Only Bionic Pancreas Bridging Study- Pediatric Transitional Study

Massachusetts General Hospital·interventional·Posted Oct 2, 2019·Updated Feb 5, 2020

In Brief

A clinical study evaluating iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog and Usual Care for Type1 Diabetes Mellitus. Completed, enrolled 20 participants across 3 sites.

Detailed 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 pediatric participants with type 1 diabetes, who will manage their diabetes with the iLet bionic pancreas compared to usual care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 2, 2019
Enrollment StartJul 9, 2018
Primary CompletionNov 19, 2018
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.8 years ago

Interventions

iLet Bionic Pancreas insulin-only configuration with Humalog or Novologdevice

iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog

Usual Careother

Usual care