The iLet Experience Study

Beta Bionics, Inc.1,875 enrolled

Overview

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.

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

1,875

Conditions

Type 1 Diabetes

Interventions

iLet Dosing Decision SoftwareDEVICE

Interoperable alternate glycemic controller

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Locations (1)

Beta Bionics

Irvine, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 1 year

Secondary Outcomes

Severe Hypoglycema/unconsciousness or seizure

Number of severe hypoglycemia events associated with unconsciousness or seizure per 100 patient years

Time frame: 1 year

DKA

Number of diabetic ketoacidosis events per 100 patient years

Time frame: 1 year

Unanticipated Adverse Device Effects

Rate of unanticipated adverse device effects

Time frame: 1 year

Mean CGM Glucose

Mean glucose as determined by CGM after 1 year of iLet use

Time frame: 1 year

Time < 54 mg/dL

Percentage of time with CGM glucose \< 54 mg/dL

Time frame: 1 year

Time < 70 mg/dL

Percentage of time with CGM glucose \< 70 mg/dL

Time frame: 1 year

Time in Range

Percentage of time with CGM glucose 70-180 mg/dL

Time frame: 1 year

Time > 180 mg/dL

Percentage of time with CGM glucose \> 180 mg/dL

Central Contacts

Courtney Balliro, BS RN

CONTACT

978-500-2456 cballiro@betabionics.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Time > 250 mg/dL

Percentage of time with CGM glucose \> 250 mg/dL

Time frame: 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

Time frame: 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.

Time frame: 1 year

Mean glucose coefficient of variation

Mean CGM glucose Intrasubject coefficient of variation

Time frame: 1 year

Time in BG-Run mode

Percent of time spent in BG-run mode

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 1 year

Unanticipated Adverse Device Effects during BG-run mode

Rate of unanticipated adverse device effects during BG-run mode

Time frame: 1 year

Average duration of BG-run mode episodes

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 1 year

Insulin TDD

Insulin total daily dose (u/kg/day)

Time frame: 1 year

Mean Baseline HbA1c of all Participants

The last available baseline HbA1c value (when available) will be reported as the mean ± standard deviation.

Time frame: Baseline

Mean HbA1c on iLet

The last available HbA1c value during the study period (when available) will be reported as the mean ± standard deviation.

Time frame: 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.

Time frame: 1 year or final available during study period compared to baseline