Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT04112069
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2019-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Insulin-Only Bionic Pancreas Bridging Study- Pediatric Transitional Study
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
The Insulin-Only Bionic Pancreas Bridging Study- Pediatric Transitional Study
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The iLet is a closed-loop delivery system that can be used in insulin-only, bihormonal, or glucagon-only configurations. Previous studies have utilized a phone-based bionic pancreas. The iLet consists of a touchscreen-enabled, menu-driven user interface and an onboard microprocessor that provides a comprehensive and standalone platform, which allows the iLet to operate independently of smartphones or other devices and without the need for internet support during routine operation.
This is a multicenter study of pediatric participants with type 1 diabetes, who will manage their diabetes with the iLet bionic pancreas compared to usual care.
This is a multicenter study of pediatric participants with type 1 diabetes, who will manage their diabetes with the iLet bionic pancreas compared to usual care.
Detailed Description:
20 pediatric participants from three clinical sites (Colorado, Nemours, and Stanford) will take part in the Pediatric Transitional Study Session to assess the efficacy, safety, and reliability of the insulin-only configuration of the bionic pancreas in regulating glycemia in pediatric subjects in a more supervised setting prior to beginning the true outpatient study. The Pediatric Transitional Study Session will consist of a multi-center, two-period, random-order, cross-over, pilot study in 20 pediatric participants 6-17 years old with T1D (\~ 6 adolescent participants at Colorado 12-17 years old, \~ 6 pre-adolescent participants at Nemours 6-11 years old, and \~ 8 pediatrics subjects at Stanford 6-17 years old). Insulin therapy for each participant will be administered (i) in one period using the iLet in the insulin-only configuration with the iLet pigtail adapter and the iLet ready-to-fill insulin cartridge, the Contact Detach infusion set, the Dexcom G5 CGM, and the insulin analog that they use for their usual care (either Humalog or Novolog), and (ii) in the other period using the participant's own usual care (UC), where each participant will wear a Dexcom G5 CGM. Both experimental periods will be followed by round-the-clock, remote, telemetric monitoring for hyperglycemia (\> 300 mg/dl for ≥ 90 minutes) and hypoglycemia (\< 50 mg/dl for ≥ 15 minutes). The two experimental periods will each span 5 days, including 4 nights (e.g. Monday-Friday). A washout period of \~ 3 days in duration will separate the two experimental periods of the Pediatric Transitional Study Session.
Both study periods will be conducted in the same clinically supervised setting during each of the 5 days and at home under parental supervision or other overnight companion who is available to serve as an emergency contact during each of the 4 nights. Parents/guardians must be present (i.e. in the house or building) while the participant is home and sleeping and will serve as the contact person for overnight alerts. During the daytime in the Pediatric Transitional Study Session, participants of each cohort will be with the clinical study staff at each of the three clinical sites and will engage in common activities such that meals and activities can be well-characterized and supervised. For further quantification of stress due to exercise, activity monitors will be worn by all of the participants in both periods of the study. In terms of physical activity, diet, and remote monitoring for hypo- and hyperglycemia, parity will be maintained between both study periods.
All 20 pediatric participants in the Pediatric Transitional Study Session will use insulin pump therapy for their usual diabetes management. The Dexcom G5 CGM will serve as the input CGM to the iLet for all 20 pediatric participants. The cohort of 6 adolescent participants at Colorado and 6 pre-adolescent participants at Nemours, and 8 participants at Stanford might overlap or might not overlap in time.
Both study periods will be conducted in the same clinically supervised setting during each of the 5 days and at home under parental supervision or other overnight companion who is available to serve as an emergency contact during each of the 4 nights. Parents/guardians must be present (i.e. in the house or building) while the participant is home and sleeping and will serve as the contact person for overnight alerts. During the daytime in the Pediatric Transitional Study Session, participants of each cohort will be with the clinical study staff at each of the three clinical sites and will engage in common activities such that meals and activities can be well-characterized and supervised. For further quantification of stress due to exercise, activity monitors will be worn by all of the participants in both periods of the study. In terms of physical activity, diet, and remote monitoring for hypo- and hyperglycemia, parity will be maintained between both study periods.
All 20 pediatric participants in the Pediatric Transitional Study Session will use insulin pump therapy for their usual diabetes management. The Dexcom G5 CGM will serve as the input CGM to the iLet for all 20 pediatric participants. The cohort of 6 adolescent participants at Colorado and 6 pre-adolescent participants at Nemours, and 8 participants at Stanford might overlap or might not overlap in time.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: