Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery

NCT04784637 | Completed Results FDA Device

• 2 other identifiers: 2003362R01DK085623-10
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 1 Diabetes Mellitus

Keywords

Artificial Pancreas (AP); Continuous Glucose Monitor (CGM); Closed Loop Control (CLC); Insulin Pump

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time in Range

  6 weeks

• Time in Hypoglycemia

  6 weeks

• INSPIRE Questionnaire

  6 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks

Device: Web Simulation Tool (WST); Device: Auto Titration Module (ATM); Device: Automated Insulin Delivery (AID) System

Group 2

EXPERIMENTAL

AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks

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

Interventions

Web Simulation Tool (WST) DEVICE

WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.

Group 1; Group 2

Behavioral Adaptation Module (BAM) DEVICE

BAM provides on-demand information to the participant primarily on glycemic risks.

Group 2

Auto Titration Module (ATM) DEVICE

ATM provides recommendations to the participant to periodically update insulin parameters.

Group 1; Group 2

Automated Insulin Delivery (AID) System DEVICE

The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.

Group 1; Group 2

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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Virginia: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• 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.

  PMID: 38662425 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insemination, Artificial, Heterologous; Drug Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Insemination, Artificial; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques; Insemination; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Drug Therapy

Results Point of Contact

• Title: Sue Brown
• Organization: University of Virginia

sab2f@virginia.edu

434-982-0602

Study Officials

• Sue Brown, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: March 5, 2021
• Study Start: July 23, 2021
• Primary Completion: December 24, 2021
• Study Completion: December 24, 2021
• Last Updated: November 7, 2024
• Results First Posted: December 5, 2022

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Generally, data will be made available after the primary publications of each study.
• Access Criteria: The Data Sharing Agreements will be formulated by the study team.

Locations

US (1)