The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to learn whether an investigational automated insulin delivery
      system ("study system") for young children (2 yo to less than 6 yo) with type 1 diabetes can
      safely improve blood glucose (sometimes called blood sugar) control.
    

Detailed description: 
      Participants will be randomized to closed loop control (CLC) system (t:slim X2 with
      Control-IQ Technology) or to standard of care where the children will continue to use his or
      her personal insulin pump or multiple daily injections. Both groups will use a continuous
      glucose monitor (CGM) throughout the study. The study system will also use a study insulin
      pump and a software algorithm to automatically give insulin and control blood glucose. This
      system is also sometimes called a "closed-loop" system.

      This study will take about 6-7 months for the child to complete. Study visits can be
      completed from home via videoconference (e.g. Zoom) without visiting the clinic or in-person
      at the clinic.

      A subset of participants will be asked to join an ancillary study with Meal Bolus and
      Exercise challenges during the extension phase. Data collected from the start of each of
      these challenges until the following morning will be excluded from the analysis of the
      extension phase.
    

Intervention name(s): Tandem t:slim X2 with Control-IQ Technology Pro; Standard Care (SC); Tandem t:slim X2 with Control-IQ Technology V1.5
Intervention type(s): Device; Device; Device
Intervention description(s): The Tandem t:slim X2 with Control-IQ Technology Pro is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is very similar to the commercially available t:sli X2 with Control-IQ but modified to accept the lower weight and Total Daily Insulin of the studied population.; Standard of Care consists in the participant existing insulin therapy (prior to enrollment) in conjunction with a study Dexcom G6 CGM. Existing insulin therapies are defined as multiple daily injections of insulin (MDI) or use of an insulin pump without hybrid closed-loop control capabilities (low-glucose suspend or predictive low-glucose suspend functionality is permitted).; The Tandem t:slim X2 with Control-IQ Technology V1.5 is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is derived from the commercially available t:slim X2 with Control-IQ, with additional features.
Intervention MeSH terms: Ferrous fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Control-IQ Technology; Insulin Pump; Closed Loop Control (CLC); Continuous Glucose Monitor (CGM); Multiple Daily Injections (MDI)