Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this pilot study is to test the safety and feasibility of using two or three
      research modules in conjunction with an automated insulin delivery device (AID).
    

Detailed description: 
      This concept is implemented in the Adaptive Biobehavioral Control (ABC) system - ABC will use
      human-machine co-adaptation of AID, recognizing both the necessity for the control algorithm
      to adapt to changes in human physiology, and the necessity for the person to adapt to AID
      action. ABC will be implemented on the Web Information Tool (WIT) platform/system and
      includes the following modules to be used alongside the automated insulin delivery device
      facilitating behavioral adaptation:

        -  Behavioral Adaptation Module (BAM) - a behavioral intervention deployed in a mobile app
           to assist a person's adaptation to automated insulin delivery by information and risk
           assessment primarily regarding glycemic risks, and

        -  Auto Titration Module (ATM) - a web-based tool with an automated procedure to track risk
           status and changes in the participant's metabolic profile. This module will present
           updated insulin control parameters to the user once a week using a web-based format
           accessible to the participant.

        -  Web-based Simulation Tool (WST) --a web-based education tool for participants to
           interact with their data to visualize and replay various scenarios to understand the
           impact of insulin parameter changes.

      Design: Two-week baseline use of personal AID system followed by randomization 1:1 into two
      groups.

        -  Group 1 will use their personal AID system and add an auto titration module (ATM) and
           web simulation tool (WST) in which insulin parameters may be adjusted on a weekly basis.

        -  Group 2 will use their personal AID system and add the ATM / WST on a weekly basis as
           well as a behavioral adaptation module (BAM). The BAM will consist of information
           modules in which information only is given to participants (e.g. hypoglycemic risks).
    

Intervention name(s): Web Simulation Tool (WST); Behavioral Adaptation Module (BAM); Auto Titration Module (ATM); Automated Insulin Delivery (AID) System
Intervention type(s): Device; Device; Device; Device
Intervention description(s): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.; BAM provides on-demand information to the participant primarily on glycemic risks.; ATM provides recommendations to the participant to periodically update insulin parameters.; The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Artificial Pancreas (AP); Continuous Glucose Monitor (CGM); Closed Loop Control (CLC); Insulin Pump