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Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery

Primary Purpose

Type 1 Diabetes Mellitus

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Web Simulation Tool (WST)

Behavioral Adaptation Module (BAM)

Auto Titration Module (ATM)

Automated Insulin Delivery (AID) System

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Insulin Pump

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Virginia Center for Diabetes Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group 1

Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Time in Hypoglycemia

Percent of CGM readings <70 mg/dL

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.

Full Information

NCT ID

NCT04784637

First Posted

December 16, 2020

Last Updated

November 7, 2022

Sponsor

University of Virginia

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT04784637

Brief Title

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

July 23, 2021 (Actual)

Primary Completion Date

December 24, 2021 (Actual)

Study Completion Date

December 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Virginia

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes Mellitus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

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

Arm Title

Group 2

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Web Simulation Tool (WST)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Behavioral Adaptation Module (BAM)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Auto Titration Module (ATM)

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Automated Insulin Delivery (AID) System

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of SAE or ADE Related to the Use of ATM / WST and BAM Modules.

Description

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.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Time in Range

Description

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 Frame

6 weeks

Title

Time in Hypoglycemia

Description

Percent of CGM readings <70 mg/dL

Time Frame

6 weeks

Title

INSPIRE Questionnaire

Description

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sue Brown, MD

Organizational Affiliation

University of Virginia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Virginia Center for Diabetes Technology

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery

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