The Insulin-Only Bionic Pancreas Bridging Study- Pediatric Transitional Study
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

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.
    

Intervention name(s): iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog; Usual Care
Intervention type(s): Device; Other
Intervention description(s): iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog; Usual care
Intervention MeSH terms: Insulin Lispro; Insulin Aspart; Pancrelipase
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bionic pancreas; Closed loop; Insulin; Continuous glucose monitor