Clinical trial NCT04784637: Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery
Official title: Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery: A Randomized, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Artificial Pancreas (AP)
Continuous Glucose Monitor (CGM)
Closed Loop Control (CLC)
Insulin Pump
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-03-05
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Age ≥18.0 and ≤70 years old at time of consent
2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
3. Currently using insulin pump for at least six months
4. Currently using insulin for at least six months
5. 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).
6. 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
7. Access to internet and willingness to upload data during the study as needed
8. Willing to use an app on a smart phone during the study.
9. For females, not currently known to be pregnant or breastfeeding
10. 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.
11. 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
12. Total daily insulin dose (TDD) at least 10 units per day
13. 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)
14. An understanding and willingness to follow the protocol and signed informed consent

Exclusion Criteria:

1. Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
2. 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.
3. History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
4. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
5. Currently being treated for a seizure disorder
6. Hemophilia or any other bleeding disorder
7. Planned surgery during study duration
8. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
9. 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.

Primary outcomes:
measure: Number of SAE or ADE Related to the Use of ATM / WST and BAM Modules.
timeFrame: 6 weeks
Secondary outcomes:
measure: Time in Range
timeFrame: 6 weeks
measure: Time in Hypoglycemia
timeFrame: 6 weeks
measure: INSPIRE Questionnaire
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for Diabetes Technology
state: Virginia
Study officials:
affiliation: University of Virginia
name: Sue Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colmegna P, McFadden R, Fabris C, Lobo B, Nass R, Oliveri MC, Brown SA, Kovatchev B. Adaptive Biobehavioral Control: A Pilot Analysis of Human-Machine Coadaptation in Type 1 Diabetes. Diabetes Technol Ther. 2024 Sep;26(9):644-651. doi: 10.1089/dia.2023.0399. Epub 2024 Apr 30.