RightFit
RecruitingPhase not listed

The iLet Experience Study

iLet Dosing Decision Software Postmarket Surveillance Plan (PS240001): The iLet Experience Study

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This one-year study checks how safe the iLet Dosing Decision Software is and how well it works in everyday use. It is for people age 6 or older with type 1 diabetes who have been prescribed the iLet Bionic Pancreas System.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have type 1 diabetes, be at least 6 years old, and have a prescription for the iLet Bionic Pancreas System.
  • Use or plan to use U100 Novolog or U100 Humalog in ready-to-fill cartridges, or U100 Fiasp PumpCart in pre-filled 1.6 mL cartridges.
  • Agree to share HbA1c results (a blood test of average blood sugar) from the 6 months before starting iLet and the last 6 months of the study.
  • Agree to share continuous glucose monitor (CGM) data from the month before starting iLet, if available. A CGM tracks blood sugar.
  • For females: not be pregnant or plan to become pregnant in the next 12 months.
  • Be able to respond to alerts and alarms and handle basic diabetes self-care.
  • Live full-time in the US and be able to speak and read English.
  • Agree and be able to download and keep the iLet Mobile App active, upload device data regularly, answer starting and monthly surveys, and share CGM and follow-up data as needed.

Who can't join

  • Have any form of diabetes other than type 1, or congenital hyperinsulinism (a condition present from birth that causes too much insulin).
  • Use or plan to use insulin in iLet other than U100 Novolog or U100 Humalog in ready-to-fill cartridges, or U100 Fiasp PumpCart in pre-filled 1.6 mL cartridges.
  • Have kidney failure treated with dialysis, a treatment that removes waste and extra fluid from the blood.
  • Use or plan to use the medicine hydroxyurea.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CA