Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784637
Status:
COMPLETED
Last Update Posted:
2022-12-05
First Post:
2020-12-16
Brief Title:
Adaptive Biobehavioral Control ABC of Automated Insulin Delivery
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Adaptive Biobehavioral Control ABC of Automated Insulin Delivery A Randomized Controlled Pilot Study
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 platformsystem 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 persons 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 participants 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 11 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 eg hypoglycemic risks
Behavioral Adaptation Module BAM - a behavioral intervention deployed in a mobile app to assist a persons 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 participants 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 11 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 eg hypoglycemic risks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2R01DK085623-10 | NIH | None | httpsreporternihgovquickSearch2R01DK085623-10 |