Fully Automated Closed Loop Control in Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The study team will be comparing two investigational Artificial Pancreas (AP) systems that
      the UVA Center for Diabetes Technology has developed. An artificial pancreas system delivers
      insulin automatically based on a blood glucose level that is provided from a continuous
      glucose monitor (CGM).
    

Detailed description: 
      Maintaining blood glucose (BG) control among adolescents with Type 1 diabetes (T1D) is
      arguably the greatest challenge in the entire field of T1D. One reason for this poor control
      relates to missed meal boluses, which affects 65% of adolescents at least once weekly, with
      38% missing at least 15% of their boluses. Adolescents who miss four boluses weekly
      experience an increase of 1% in their HbA1c. While the advent of the artificial pancreas (AP)
      offers promise of safe reductions in HbA1c, the study team previously found that the AP only
      partly compensates for missed prandial insulin -demonstrating that some form of meal
      announcement is necessary for good BG control, even with an AP. One way to automate this
      process is by sharing the prandial dosing responsibilities between an automated insulin
      priming (based on continuous glucose monitor condition predictive of a safe situation for
      such insulin dosing) and a closed loop controller capable of reconstructing (estimating) the
      prevailing glucose rate of appearance from an unannounced meal. The study team has developed
      such an insulin priming schema and integrated it into a new version of the robust Model
      Predictive Controller University of Virginia AP system (called the RocketAP).

      In the current study, the investigators are testing this new AP system in two configurations:
      hybrid and fully automated, among up to 20 adolescents. The primary outcome will be one of
      efficacy in assessing how well the new system controls post-prandial BG in the absence of
      carbohydrate (CHO) announcement as compared to the same situation but using the Control-IQ
      closed loop algorithm, also designed at UVa and using the same modular architecture and
      safety system, but without insulin priming and with a less advanced model-based controller.
      Further comparisons will be made to BG control on RocketAP with CHO announcement and on
      Control-IQ with CHO announcement. Adolescents will be started on the respective University of
      Virginia AP systems (RocketAP and Control-IQ in random order, both implemented on the DiAs
      platform, MAF 2109) and followed over the course of two dinners on each of the two platforms:
      a dinner where CHO is announced as normal and the 2nd where no announcement is made.

      The study team hypothesize that performances of RocketAP in fully automated mode will lie in
      between Hybrid and Fully Automated Control-IQ. In time, this may provide an opportunity to
      improve BG control among adolescents who miss meal announcement.
    

Intervention name(s): RocketAP; USS Virginia
Intervention type(s): Device; Device
Intervention description(s): Artificial pancreas system which is designed to be able to identify when you have eaten and provide insulin for this meal; Artificial pancreas system which responds to glucose fluctuations by modulating insulin delivery but does not specifically detect meal ingestion
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized cross-over trial assessing glycemic responses to two different approaches to insulin dosing for carbohydrate ingestion (announced vs. unannounced), with two different AP systems (RocketAP vs. USS Virginia, aka Control-IQ, in random order)
Masking: None (Open Label)
Primary purpose: Other
Keywords: Artificial Pancreas (AP); Continuous Glucose Monitor (CGM); Insulin Pump; Closed Loop Control