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.

Primary Objective

This is a study assessing the feasibility of deploying the iLet bionic pancreas system in the insulin-only configuration to pump-naive MDI users with type 1 diabetes, in the setting of being recruited from community-based primary care practices and being trained and managed by primary care providers, and in pump- and CGM-experienced (sensor-augmented pump or hybrid closed-loop) users with type 1 diabetes recruited from, trained, and managed by an academic endocrinology practice. In both practice settings, the exclusive use of telehealth (TH) visits will be assessed, as will the use of in-person (IP) visits. We will enroll 40 adult volunteers with type 1 diabetes, 20 who are insulin pump naive MDI users enrolled from community primary care practices by University of Colorado Family Medicine and 20 who are technology-savvy sensor-augmented pump or hybrid closed-loop users enrolled by the Massachusetts General Hospital Diabetes Clinical Research Center. Ten of the participants at each center will be trained and managed throughout the trial using in-person visits and the other ten from each center will be trained and managed throughout the trial exclusively via telehealth visits. This will result in four study cohorts overall (endocrinology in-person, endocrinology telehealth, primary care in-person, primary care telehealth). Subjects in all four groups will each participate, in random order, in one 14-day study arm under their own usual care (UC arm) and one 14-day study arm under the insulin-only configuration of the iLet bionic pancreas (iLet arm).

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Description

The purpose of this study is to learn more about the safety and effectiveness of the iLet - Bionic pancreas device for treating Type 1 diabetes when implemented in primary care and endocrinology, and both in-person and via telehealth.

Details
Age

Adult

Eligibility

Participants must be on multiple daily injections and insulin pump naive.

Type of Study

Device Feasibility

Scope

National

Locations

Department Specific Free Standing Clinic
Lone Tree Medical Center
University of Colorado Hospital

Principal Investigator
Photograph of Tamara Oser,  MD

Tamara Oser, MD

Study ID

Protocol Number: 21-3272

More information available at ClinicalTrials.gov: NCT05168657

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