NCT05610111

Adaptive Biobehavioral Control (ABC) in a Closed-Loop System

Adaptive Biobehavioral Control (ABC) in a Closed-Loop System: A Randomized Crossover Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Sue Brown · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to test a Web-based Information Tool (WIT) software providing additional information regarding time in range, GMI, hypo- and hyperglycemia risks, variability tracker, daily glycemic profiles, and potential changes of insulin pump parameters, to users of a commercially available Closed-Loop Control (CLC) System (Control-IQ Technology).

Detailed description

This is a randomized two-arm crossover group trial in which both groups will use the CLC (Control-IQ) plus WIT. The difference between the two groups will be the order of the interventions. Each group will undergo screening and collection of baseline data from their personal AID system (Control-IQ) followed by randomization 1:1 into two groups. Both groups will have the same three interventions but will progress in the study in a different order allowing for crossover comparisons. The three interventions are: * Use of personal CLC system for 2 weeks * Use of personal CLC system and adding a behavioral adaptation module (BAM) for 4 weeks * Use of personal CLC system and adding the ABC which includes: BAM and PAM (which includes ATM and WST described below) for 16 weeks. The BAM will consist of modules in which information only is given to participants (e.g. time in range, Glucose Management Indicator (GMI), hyper-and hypoglycemic risks, daily glycemic profiles, and variability tracker). The PAM includes auto suggestions for titration of insulin pump parameters every two weeks (ATM) and is aided by a web simulation tool (WST) which can replay 'what if' scenarios for the participant based on various combinations of insulin pump parameter changes.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	CLC + BAM	Closed Loop Control with the Behavioral Adaption Module for 4 weeks
DEVICE	CLC + ABC	Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks

Timeline

• Start date: 2023-01-18
• Primary completion: 2024-09-26
• Completion: 2024-09-28
• First posted: 2022-11-09
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study