Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery

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

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).

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: Web Simulation Tool (WST); Device: Auto Titration Module (ATM); Device: Automated Insulin Delivery (AID) System; Device: Behavioral Adaptation Module (BAM)

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).

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Center for Diabetes Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1; AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks	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: 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.
EXPERIMENTAL: Group 2; AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks	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: 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.; Device: Behavioral Adaptation Module (BAM); BAM provides on-demand information to the participant primarily on glycemic risks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of SAE or ADE Related to the Use of ATM / WST and BAM Modules.	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in Range	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.	6 weeks
Time in Hypoglycemia	Percent of CGM readings <70 mg/dL	6 weeks
INSPIRE Questionnaire	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.	6 weeks

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 23, 2021
• Primary Completion (ACTUAL): December 24, 2021
• Study Completion (ACTUAL): December 24, 2021

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: March 4, 2021
• First Posted (ACTUAL): March 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Artificial Pancreas (AP); Continuous Glucose Monitor (CGM); Closed Loop Control (CLC); Insulin Pump
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: 200336; 2R01DK085623-10 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
• IPD Sharing Time Frame: Generally, data will be made available after the primary publications of each study.
• IPD Sharing Access Criteria: The Data Sharing Agreements will be formulated by the study team.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes