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.

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.

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