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

NCT05610111 | Completed DMC FDA Device

• 2 other identifiers: 2203002R01DK085623
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Closed-Loop Control (CLC); Continuous Glucose Monitoring (CGM); Artificial Pancreas (AP); Tandem t:slim Insulin Pump with Control-IQ Technology

Outcome Measures

Primary Outcomes (1)

• CGM-measured percent time in range 70-180 mg/dL

  The primary outcome for this study is CGM-measured percent time in range 70-180 mg/dL over the last 4-week periods on CLC+ABC versus 2 weeks of the current CLC system. The intervention will be considered effective if the CLC+ABC is superior to the CLC alone in a crossover design using a statistical significance of α=0.05. To preserve the overall type 1 error for selected key secondary endpoints, a hierarchical testing procedure will be used. If the primary analysis for time in range described above results in a statistically significant result (p \< 0.05), then testing (similar to the model for the primary outcome) will proceed to the next key secondary outcome metric in the following order entered.

  4 weeks

Secondary Outcomes (4)

• CGM-measured percent above 180 mg/dL during the day

  4 weeks

• CGM-measured percent below 70 mg/dL during the day

  4 weeks

• CGM-measured mean glucose

  4 weeks

• CGM-measured coefficient of variation during the day

  4 weeks

Study Arms (2)

CLC, then CLC+BAM, then CLC+ABC

ACTIVE COMPARATOR

Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks.

Device: CLC + BAM; Device: CLC + ABC

CLC+ABC, then CLC+BAM, then CLC

ACTIVE COMPARATOR

Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks.

Device: CLC + BAM; Device: CLC + ABC

Interventions

CLC + BAM DEVICE

Closed Loop Control with the Behavioral Adaption Module for 4 weeks

CLC+ABC, then CLC+BAM, then CLC; CLC, then CLC+BAM, then CLC+ABC

CLC + ABC DEVICE

Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks

CLC+ABC, then CLC+BAM, then CLC; CLC, then CLC+BAM, then CLC+ABC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 an insulin pump for at least six months
• Currently using insulin for at least six months
• Currently using the t:slim X2 insulin pump for at least two months
• Currently using or anticipated to be using the t:slim X2 insulin pump with Control-IQ technology at randomization (Visit 3).
• 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 as part (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 (biguanides), GLP-1 receptor agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
• An understanding and willingness to follow the protocol and signed informed consent

You may not qualify if:

• Concurrent use of any non-insulin glucose-lowering agent other than metformin or GLP-1 receptor agonists following screening (including 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.

Sponsors & Collaborators

• Sue Brown: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Tandem Diabetes Care, Inc.: collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• Kovatchev BP, Colmegna P, Pavan J, Diaz Castaneda JL, Villa-Tamayo MF, Koravi CLK, Santini G, Alix C, Stumpf M, Brown SA. Human-machine co-adaptation to automated insulin delivery: a randomised clinical trial using digital twin technology. NPJ Digit Med. 2025 May 6;8(1):253. doi: 10.1038/s41746-025-01679-y.

  PMID: 40329052 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sue Brown, MD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Physician

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 9, 2022
• Study Start: January 18, 2023
• Primary Completion: September 26, 2024
• Study Completion: September 28, 2024
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Generally following completion of publications.
• Access Criteria: Limited deidentified data will be shared while sharing of complete data sets will be regulated by Data-Sharing Agreements.

Locations

US (1)