RECRUITING

The ILet Experience Study

Conditions

Type 1 Diabetes diabetes postmarket registry iLet Bionic Pancreas Beta Bionics iLet Dosing Decision Software

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-01

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06891898

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Courtney Balliro, BS RN

CONTACT

978-500-2456

cballiro@betabionics.com

Principal Investigator

Steven J Russell, MD, PhD

PRINCIPAL_INVESTIGATOR

Beta Bionics

Study Locations (Sites)

Beta Bionics

Irvine, California, 92618

United States

Collaborators and Investigators

Sponsor: Beta Bionics, Inc.

Steven J Russell, MD, PhD, PRINCIPAL_INVESTIGATOR, Beta Bionics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01

Study Completion Date2027-06

Study Record Updates

Study Start Date2024-05-01

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

diabetes
postmarket registry
iLet Bionic Pancreas
Beta Bionics
iLet Dosing Decision Software

Additional Relevant MeSH Terms

Type 1 Diabetes