Clinical trial NCT06891898: The iLet Experience Study
Official title: iLet Dosing Decision Software Postmarket Surveillance Plan (PS240001): The iLet Experience Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Keywords: diabetes
postmarket registry
iLet Bionic Pancreas
Beta Bionics
iLet Dosing Decision Software
Lead sponsor: Beta Bionics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: The Scripps Research Institute
First posted: 2025-03-24
Enrollment: 1875
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Severe Hypoglycemia/cognitive impairment
timeFrame: 1 year
Secondary outcomes:
measure: Severe Hypoglycema/unconsciousness or seizure
timeFrame: 1 year
measure: DKA
timeFrame: 1 year
measure: Unanticipated Adverse Device Effects
timeFrame: 1 year
measure: Mean CGM Glucose
timeFrame: 1 year
measure: Time < 54 mg/dL
timeFrame: 1 year
measure: Time < 70 mg/dL
timeFrame: 1 year
measure: Time in Range
timeFrame: 1 year
measure: Time > 180 mg/dL
timeFrame: 1 year
measure: Time > 250 mg/dL
timeFrame: 1 year
measure: Rate of CGM-determined hypoglycemic events
timeFrame: 1 year
measure: Rate of CGM-determined hyperglycemic events
timeFrame: 1 year
measure: Mean glucose coefficient of variation
timeFrame: 1 year
measure: Time in BG-Run mode
timeFrame: 1 year
measure: Time in BG-run mode for longer than 4 hours
timeFrame: 1 year
measure: Severe Hypoglycemia During BG-run mode
timeFrame: 1 year
measure: DKA During BG-run mode
timeFrame: 1 year
measure: Unanticipated Adverse Device Effects during BG-run mode
timeFrame: 1 year
measure: Average duration of BG-run mode episodes
timeFrame: 1 year
measure: Percentage of time insulin suspended during BG-Run episodes >4 hours
timeFrame: 1 year
measure: Mean CGM glucose at time of entry into BG-run episodes >4 hours
timeFrame: 1 year
measure: Mean CGM glucose at time of exit from BG-run episodes >4 hours
timeFrame: 1 year
measure: Insulin TDD
timeFrame: 1 year
measure: Mean Baseline HbA1c of all Participants
timeFrame: Baseline
measure: Mean HbA1c on iLet
timeFrame: 1 year or final available during study period
measure: Mean change in HbA1c
timeFrame: 1 year or final available during study period compared to baseline
Other outcomes:
measure: Mean number of swipes to unlock the iLet per day
timeFrame: 1 year
measure: Mean number of total meal announcements made per day
timeFrame: 1 year
measure: Average number of breakfast announcements made per day
timeFrame: 1 year
measure: Average number of lunch announcements made per day
timeFrame: 1 year
measure: Average number of dinner announcements made per day
timeFrame: 1 year
Locations:
city: Irvine
country: United States
facility: Beta Bionics
state: California
Study officials:
affiliation: Beta Bionics
name: Steven J Russell, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: