NCT04784637

Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery

Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery: A Randomized, Controlled Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Web Simulation Tool (WST)	WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
DEVICE	Behavioral Adaptation Module (BAM)	BAM provides on-demand information to the participant primarily on glycemic risks.
DEVICE	Auto Titration Module (ATM)	ATM provides recommendations to the participant to periodically update insulin parameters.
DEVICE	Automated Insulin Delivery (AID) System	The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.

Timeline

• Start date: 2021-07-23
• Primary completion: 2021-12-24
• Completion: 2021-12-24
• First posted: 2021-03-05
• Last updated: 2024-11-07
• Results posted: 2022-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study