Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth

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).

Conditions

• Diabetes 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

Interventions

DEVICE

Bionic Pancreas

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.

OTHER

Usual Care

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

Sponsors & Collaborators

• Beta Bionics, Inc.

  collaborator INDUSTRY

• Massachusetts General Hospital

  collaborator OTHER

• University of Colorado, Denver

  lead OTHER

Principal Investigators

• Sean M Oser, MD, MPH · University of Colorado, Denver

• Tamara K Oser, MD · University of Colorado, Denver

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-31

Primary Completion

2023-05-23

Completion

2023-05-23

FDA Device

Yes

Countries

• United States

Study Locations