Primary Care Pragmatic, Real World Experience for Automated Insulin Delivery

Summary

The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is:

Can the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)?

Researchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care.

Participants will:

Use the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks

Conditions

• Type 1 Diabetes (T1D)
• Type 2 Diabetes
• Diabetes, Autoimmune
• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type I
• Diabetes, Type II
• Diabetes
• Diabetes Mellitus, Insulin-Dependent
• Diabetes Mellitus Type II
• Diabetes Type 2 on Insulin

Interventions

DEVICE

Bionic Pancreas

The intervention group will use the iLet Bionic Pancreas (BP) for 13-weeks. They will be trained on the iLet BP system and its components by a Certified iLet Trainer. They will also be trained on how to use the study continuous glucose monitor (CGM) system, blood glucose meter, and ketone meter. Participants will have four mid-period follow up phone calls to review medications, ongoing eligibility, and solicit any occurrences of adverse events and device issues. At the end of 13-weeks, they will complete final visit tasks and will be transitioned back to their pre-study insulin delivery method with guidance provided by a study investigator.

OTHER

Routine Care

Participants will continue with their current diabetes treatment. Participants will be trained on the use of the study blood glucose meter. They will have four mid-period follow up phone calls to review medications, ongoing eligibility, and solicit any occurrences of adverse events. At the end of 13-weeks, they will complete final visit tasks and will be asked if they would like to participate in the observational extension phase where they will use the iLet Bionic Pancreas for 13 weeks.

Sponsors & Collaborators

• Massachusetts General Hospital

  collaborator OTHER

• Beta Bionics, Inc.

  collaborator INDUSTRY

• Ann & Robert H Lurie Children's Hospital of Chicago

  collaborator OTHER

• University of Colorado, Denver

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-16

Primary Completion

2026-10-01

Completion

2029-04-01

FDA Device

Yes

Countries

• United States

Study Locations