The iLet Experience Study
ConditionType 1 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6+
SponsorBeta Bionics, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with type 1 diabetes and prescribed the iLet Bionic Pancreas System
At least 6 years of age
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
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
Disqualifiers
Type 2 diabetes, cystic fibrosis-related diabetes, congenital hyperinsulinism, pancreatogenic diabetes, or any form of diabetes mellitus other than type 1 diabetes
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
End-stage renal disease on renal replacement therapy (peritoneal dialysis or hemodialysis)
Use or planned use of hydroxyurea
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
iLet Dosing Decision Software
DeviceInteroperable alternate glycemic controller
Treatment groups
1,875 Participants
are divided into 1 treatment groupGroup A: iLet Bionic Pancreas1 intervention
Trial outcomes
Primary outcomes
1
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 yearSecondary outcomes
1
Severe Hypoglycema/unconsciousness or seizure
Number of severe hypoglycemia events associated with unconsciousness or seizure per 100 patient years
Time frame
1 year2
DKA
Number of diabetic ketoacidosis events per 100 patient years
Time frame
1 year3
Unanticipated Adverse Device Effects
Rate of unanticipated adverse device effects
Time frame
1 year4
Mean CGM Glucose
Mean glucose as determined by CGM after 1 year of iLet use
Time frame
1 yearOther outcomes
1
Mean number of swipes to unlock the iLet per day
Mean number of swipes to unlock the iLet per day
Time frame
1 year2
Mean number of total meal announcements made per day
Mean number of meal announcements made per day - total regardless of meal type
Time frame
1 year3
Average number of breakfast announcements made per day
Mean number of total breakfast announcements made per day
Time frame
1 year4
Average number of lunch announcements made per day
Mean number of total lunch announcements made per day
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beta Bionics, Inc.
Lead sponsor
The Scripps Research Institute
Collaborator
Source ClinicalTrials.gov