Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery

Not Applicable

Completed

Conditions: Type 1 Diabetes Mellitus

Interventions: Device: Web Simulation Tool (WST)
Device: Auto Titration Module (ATM)
Device: Behavioral Adaptation Module (BAM)
Device: Automated Insulin Delivery (AID) System

Registration Number: NCT04784637

Lead Sponsor: University of Virginia

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) 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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

Inclusion Criteria

Age ≥18.0 and ≤70 years old at time of consent
Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
Currently using insulin pump for at least six months
Currently using insulin for at least six months
Currently using or anticipated to be using the t:slim X2 insulin pump with Control-IQ technology at the start of the run-in phase (Visit 1).
Using or willing to use insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
Access to internet and willingness to upload data during the study as needed
Willing to use an app on a smart phone during the study.
For females, not currently known to be pregnant or breastfeeding
If female, sexually active, and of childbearing potential, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
Willingness to use only insulin analogs approved for use in the t:slim X2 pump such as lispro (Humalog) or aspart (Novolog) and not use ultra-rapid acting insulin analogs (e.g. FiAsp) during the study
Total daily insulin dose (TDD) at least 10 units per day
Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, and sulfonylureas)
An understanding and willingness to follow the protocol and signed informed consent

Exclusion Criteria

Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
A condition, which in the opinion of the investigator or designee, would put the participant at risk or interfere with the completion of the protocol.
History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
Currently being treated for a seizure disorder
Hemophilia or any other bleeding disorder
Planned surgery during study duration
Participation in another pharmaceutical or device trial at the time of enrollment or during the study
Having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (e.g. study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Auto Titration Module (ATM)	AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks
Group 1	Web Simulation Tool (WST)	AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks
Group 1	Automated Insulin Delivery (AID) System	AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks
Group 2	Web Simulation Tool (WST)	AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks
Group 2	Behavioral Adaptation Module (BAM)	AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks
Group 2	Auto Titration Module (ATM)	AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks
Group 2	Automated Insulin Delivery (AID) System	AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks

Primary Outcome Measures

Name	Time	Method
Number of SAE or ADE Related to the Use of ATM / WST and BAM Modules.	6 weeks	Safety assessment of ATM / WST and BAM modules by assessing serious adverse events or adverse device effects deemed related to the use of ATM/WST and BAM modules specifically.

Secondary Outcome Measures

Name	Time	Method
Time in Range	6 weeks	Percent of CGM readings in the target ranges of 70-180mg/dL from 2 weeks of baseline compared to last 2 weeks of treatment period.
Time in Hypoglycemia	6 weeks	Percent of CGM readings \<70 mg/dL
INSPIRE Questionnaire	6 weeks	Questionnaire addressing system/technology use. The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items.