CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 54 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/NCT05168657
NCT05168657N/ACompleted
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Assessing Feasibility, Safety, and Efficacy of Deploying a Closed-loop Automated Insulin Delivery System by Community-based Primary Care Physicians and Academic Endocrinologists, in Person and Through Telehealth

University of Colorado, Denver·interventional·Posted Dec 23, 2021·Updated Oct 21, 2024

In Brief

A clinical study evaluating Bionic Pancreas and Usual Care for Diabetes Mellitus, Type 1 and 13 related conditions. Completed, enrolled 54 participants across 2 sites.

Detailed Summary

This is a study assessing the feasibility of using the insulin-only configuration of the iLet bionic pancreas with initiation in pump-naïve people with type 1 diabetes in a primary care practice with either in-person training and follow-up (PC-IP) or with training and follow-up via telehealth (PC-TH). As a comparison, the iLet will be initiated by an academic endocrinology practice with either in-person training and follow-up (EN-IP) or with training and follow-up via telehealth (EN-TH).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1, Type 1 Diabetes, Diabetes, Autoimmune, Diabetes type1, Autoimmune Diabetes, Diabetes Mellitus, Brittle, Diabetes Mellitus, Insulin-Dependent, Diabetes Mellitus, Insulin-Dependent, 1, Diabetes Mellitus, Juvenile-Onset, Diabetes Mellitus, Ketosis-Prone, Diabetes Mellitus, Sudden-Onset, Insulin-Dependent Diabetes Mellitus 1, Juvenile-Onset Diabetes, Type 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsBeta Bionics, Inc., Massachusetts General Hospital

Timeline

N/ACompletedFinished
20222023202420252026
First PostedDec 23, 2021
Enrollment StartMar 31, 2022
Primary CompletionMay 23, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.5 years ago

Interventions

Bionic Pancreasdevice

14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.

Usual Careother

14 days of the participant's usual care of their type 1 diabetes