Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The overall aim of this proposed research is to determine the safety, feasibility and
      efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and
      night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple
      48 hours in an out-patient setting.
    

Detailed description: 
      Young children with Type 1 Diabetes (T1D) in the age range of 5-8 years old are a population
      with clear needs but unique challenges regarding the application of artificial pancreas (AP)
      technologies. Young children are likely to benefit from an AP system, with current deficits
      in glycemic control that include both significant hypoglycemia and sub-optimal HbA1c levels;
      however, they have undeveloped abilities to control and interact with the AP system, posing
      potential safety issues. During the hours that these children are away from their parents at
      school and elsewhere, they lack the sophistication to operate the currently-available tools
      in an AP system--and may induce harm if they are allowed to do so, causing parental
      resistance to AP use. Commercially-available insulin pumps have mechanisms to lock access to
      children to prevent inappropriate insulin-delivery. However, the AP is more complex than an
      insulin pump, both in requiring more detailed setting information (that a child could
      adversely alter) and in providing alerts for impending low- and high-blood glucose (BG)
      levels (that one wouldn't want to lock out to child use). These functions are all run via a
      platform on a smart phone-a device with which young children may already feel a high degree
      of familiarity and thus be more likely to attempt to explore and potentially change settings.
      It is likely that young children will benefit the most from a system that gives them access
      to some AP features but provides access to other features only for their parents. In this
      sense, young children require a device that is not user-centered as much as family-centered.
      A redesign of the system to provide appropriate access to AP tools-in which certain users can
      obtain access to certain functionalities-is direly needed before children in this age range
      can benefit from the improvements in blood glucose (BG) control that the AP has to offer.
    

Intervention name(s): Diabetes Assistant (DiAs) with Closed-Loop
Intervention type(s): Device
Intervention description(s): All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes Mellitus (T1DM); Artificial Pancreas Project (APP); Diabetes Assistant (DiAs); Closed-Loop Control (CLC); Continuous Glucose Monitor; Pediatric; Insulin Pump