The ILet Experience Study

ILet Dosing Decision Software Postmarket Surveillance Plan (PS240001): the ILet Experience Study

A one-year, prospective single-arm cohort study to collect safety and effectiveness data on the iLet Dosing Decision Software during real-world use in people 6 years of age or older with type 1 diabetes (T1D) with 12 months follow-up.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: iLet Dosing Decision Software

Detailed Description

The study will compare outcomes data during iLet use to efficacy and safety outcomes data derived from epidemiological studies, such as data published by the T1D Exchange registry, and to the results of the Bionic Pancreas Pivotal Trial (BPPT), with a special emphasis on serious adverse effects such as severe hypoglycemia and DKA. An analysis will be conducted comparing glycemic outcomes during iLet use to baseline pre-iLet CGM and HbA1c data in participants who have provided this data. In addition, the study will determine the frequency and types of anticipated and unanticipated device issues experienced by users during real-world use.

• Study Type: Observational
• Enrollment (Estimated): 1875

Contacts and Locations

• Study Contact: Name: Courtney Balliro, BS RN; Phone Number: 978-500-2456; Email: cballiro@betabionics.com

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Recruiting
      • Beta Bionics
      • Contact: Steven J Russell, MD, PhD; Phone Number: 855-745-3800; Email: srussell@betabionics.com
      • Contact: Courtney Balliro, BSN; Email: cballiro@betabionics.com
      • Contact: Steven J Russell, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will include users of the iLet Dosing Decision Software who are at least 6 years old and have been diagnosed with Type 1 diabetes

Description

Inclusion Criteria:

• Users must meet the following criteria in order to be enrolled in the study:

  1. Diagnosed with type 1 diabetes and prescribed the iLet Bionic Pancreas System
  2. At least 6 years of age
  3. Using or planning to use either U100 Novolog (insulin aspart) or U100 Humalog (insulin lispro) in ready-to-fill cartridges, or U100 Fiasp® PumpCart® (insulin aspart) in pre-filled 1.6mL cartridges
  4. Willing to provide HbA1c results obtained within the 6-month period prior to starting use of the iLet and during the last 6-months of study participation
  5. Willing to provide CGM data, if available, obtained in the 1-month period prior to starting use of the iLet
  6. For females, not pregnant or planning pregnancy in the next 12 months
  7. Able to respond to alerts and alarms, and to provide basic diabetes self-management
  8. Reside full-time in the US
  9. Able to speak and read English
  10. Willing and able to download the iLet Mobile App and keep it active throughout the study and upload device data regularly
  11. Willing to answer baseline survey, monthly surveys, and share CGM data, and follow-up data, as necessary

Exclusion Criteria:

• Users with the following characteristics will not be considered candidates for the study:

  1. Type 2 diabetes, cystic fibrosis-related diabetes, congenital hyperinsulinism, pancreatogenic diabetes, or any form of diabetes mellitus other than type 1 diabetes
  2. Use or planned use of any insulin in the iLet other than U100 Novolog (insulin aspart) or U100 Humalog (insulin lispro) in ready-to-fill cartridges, or U100 Fiasp® PumpCart® (insulin aspart) in pre-filled 1.6mL cartridges
  3. End-stage renal disease on renal replacement therapy (peritoneal dialysis or hemodialysis)
  4. Use or planned use of hydroxyurea

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
iLet Bionic Pancreas; users of the iLet Bionic Pancreas installed with the iLet Dosing Decision Software	Device: iLet Dosing Decision Software; Interoperable alternate glycemic controller; Other Names: iLet Bionic Pancreas

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe Hypoglycemia/cognitive impairment	Number of severe hypoglycemia events associated with cognitive impairment requiring the assistance of a third party for treatment per 100 patient years	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe Hypoglycema/unconsciousness or seizure	Number of severe hypoglycemia events associated with unconsciousness or seizure per 100 patient years	1 year
DKA	Number of diabetic ketoacidosis events per 100 patient years	1 year
Unanticipated Adverse Device Effects	Rate of unanticipated adverse device effects	1 year
Mean CGM Glucose	Mean glucose as determined by CGM after 1 year of iLet use	1 year
Time < 54 mg/dL	Percentage of time with CGM glucose < 54 mg/dL	1 year
Time < 70 mg/dL	Percentage of time with CGM glucose < 70 mg/dL	1 year
Time in Range	Percentage of time with CGM glucose 70-180 mg/dL	1 year
Time > 180 mg/dL	Percentage of time with CGM glucose > 180 mg/dL	1 year
Time > 250 mg/dL	Percentage of time with CGM glucose > 250 mg/dL	1 year
Rate of CGM-determined hypoglycemic events	Rate of hypoglycemic events defined as at least 15 consecutive minutes of CGM glucose < 54 mg/dL - the hypoglycemic event ends when there are at least 15 consecutive minutes with a CGM glucose greater than or equal to 70 mg/dL and the participant becomes eligible for another hypoglycemic event	1 year
Rate of CGM-determined hyperglycemic events	Rate of hyperglycemic events defined as at least 90 cumulative minutes with a CGM glucose value > 300 mg/dL within a 120-minute period - the hyperglycemic event ends when there are at least 15 consecutive minutes with a CGM glucose value less than or equal to 180 mg/dL and the participant becomes eligible for another hyperglycemic event.	1 year
Mean glucose coefficient of variation	Mean CGM glucose Intrasubject coefficient of variation	1 year
Time in BG-Run mode	Percent of time spent in BG-run mode	1 year
Time in BG-run mode for longer than 4 hours	Percent of time spent in BG-run mode episodes longer than 4 hours	1 year
Severe Hypoglycemia During BG-run mode	Rate of severe hypoglycemic events beginning during a BG-run mode episode that lasted more than 4 hours or within 6 hours of a BG-run episode that lasted more than 4 hours	1 year
DKA During BG-run mode	Rate of diabetic ketoacidosis events during a BG-run mode episode that lasted more than 4 hours or within 6 hours of a BG-run episode that lasted more than 4 hours	1 year
Unanticipated Adverse Device Effects during BG-run mode	Rate of unanticipated adverse device effects during BG-run mode	1 year
Average duration of BG-run mode episodes	Average duration of BG-run mode episodes	1 year
Percentage of time insulin suspended during BG-Run episodes >4 hours	During BG-run mode episodes that lasted more than 4 hours, percentage of time no insulin could be delivered as a result of failure to enter BG values at the required intervals	1 year
Mean CGM glucose at time of entry into BG-run episodes >4 hours	Mean CGM glucose at the time of entry into BG-run mode episodes that lasted more than 4 hours	1 year
Mean CGM glucose at time of exit from BG-run episodes >4 hours	Mean CGM glucose at the time of exit from BG-run mode into CGM-run mode after episodes of BG-run mode that lasted more than 4 hours	1 year
Insulin TDD	Insulin total daily dose (u/kg/day)	1 year
Mean Baseline HbA1c of all Participants	The last available baseline HbA1c value (when available) will be reported as the mean ± standard deviation.	Baseline
Mean HbA1c on iLet	The last available HbA1c value during the study period (when available) will be reported as the mean ± standard deviation.	1 year or final available during study period
Mean change in HbA1c	The change in HbA1c from the last available baseline value to the last available value during the study period (when both values are available) will be reported as the mean ± standard deviation.	1 year or final available during study period compared to baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean number of swipes to unlock the iLet per day	Mean number of swipes to unlock the iLet per day	1 year
Mean number of total meal announcements made per day	Mean number of meal announcements made per day - total regardless of meal type	1 year
Average number of breakfast announcements made per day	Mean number of total breakfast announcements made per day	1 year
Average number of lunch announcements made per day	Mean number of total lunch announcements made per day	1 year
Average number of dinner announcements made per day	Mean number of total dinner announcements made per day	1 year

Collaborators and Investigators

• Sponsor: Beta Bionics, Inc.
• Collaborators: The Scripps Research Institute
• Investigators: Principal Investigator: Steven J Russell, MD, PhD, Beta Bionics

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: diabetes; Beta Bionics; postmarket registry; iLet Bionic Pancreas; iLet Dosing Decision Software
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1; Gastrointestinal Agents; Pancrelipase
• Other Study ID Numbers: PS240001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It has not yet been decided if IPD will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No