CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 22 enrolled
Drug / intervention
Bionic Pancreas +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/NCT03258853
NCT03258853N/ACompleted
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Feasibility of Outpatient Automated Blood Glucose Control With the iLet Bionic Pancreas for Treatment of Cystic Fibrosis Related Diabetes

Massachusetts General Hospital·interventional·Posted Aug 23, 2017·Updated Jul 20, 2023

In Brief

A clinical study evaluating Bionic Pancreas and Usual Care for Cystic Fibrosis-related Diabetes. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The current study is designed to test the feasibility of the a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults and children with cystic fibrosis related diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis-related Diabetes
CountriesUnited States
CollaboratorsBeta Bionics, Inc.

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 23, 2017
Enrollment StartAug 26, 2021
Primary CompletionJun 29, 2022
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 8.9 years ago

Interventions

Bionic Pancreasdevice

Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.

Usual Careother

Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.