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

NCT04112069 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-02-05

Study results available
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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.

Conditions

  • Type1 Diabetes Mellitus

Interventions

DEVICE

iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog

iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog

OTHER

Usual Care

Usual care

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2018-11-19
Completion
2018-11-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04112069 on ClinicalTrials.gov