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

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CLC + BAM
CLC + ABC
Sponsored by
Sue Brown
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Closed-Loop Control (CLC), Continuous Glucose Monitoring (CGM), Artificial Pancreas (AP), Tandem t:slim Insulin Pump with Control-IQ Technology

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 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 Exclusion Criteria: 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.

Sites / Locations

  • University of Virginia Center for Diabetes TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CLC, then CLC+BAM, then CLC+ABC

CLC+ABC, then CLC+BAM, then CLC

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

CGM-measured percent above 180 mg/dL during the day
A key secondary outcome is CGM-measured percent above 180mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. If the analysis results in a statistically significant result (p < 0.05), then testing will proceed to the next secondary outcome metric in the following order entered.
CGM-measured percent below 70 mg/dL during the day
A key secondary outcome is CGM-measured percent below 70 mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. If the analysis results in a statistically significant result (p < 0.05), then testing will proceed to the next secondary outcome metric in the following order entered.
CGM-measured mean glucose
A key secondary outcome is CGM-measured mean glucose comparing the last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. If the analysis results in a statistically significant result (p < 0.05), then testing will proceed to the next secondary outcome metric in the following order entered.
CGM-measured coefficient of variation during the day
A key secondary outcome is CGM-measured percent coefficient of variation during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone.

Full Information

First Posted
November 2, 2022
Last Updated
January 25, 2023
Sponsor
Sue Brown
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tandem Diabetes Care, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05610111
Brief Title
Adaptive Biobehavioral Control (ABC) in a Closed-Loop System
Acronym
ABC-WIT
Official Title
Adaptive Biobehavioral Control (ABC) in a Closed-Loop System: A Randomized Crossover Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 3, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sue Brown
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tandem Diabetes Care, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
This is a randomized two-arm crossover group trial in which both groups will use the CLC (Control-IQ) plus WIT. The difference between the two groups will be the order of the interventions. Each group will undergo screening and collection of baseline data from their personal AID system (Control-IQ) followed by randomization 1:1 into two groups. Both groups will have the same three interventions but will progress in the study in a different order allowing for crossover comparisons. The three interventions are: Use of personal CLC system for 2 weeks Use of personal CLC system and adding a behavioral adaptation module (BAM) for 4 weeks Use of personal CLC system and adding the ABC which includes: BAM and PAM (which includes ATM and WST described below) for 16 weeks. The BAM will consist of modules in which information only is given to participants (e.g. time in range, Glucose Management Indicator (GMI), hyper-and hypoglycemic risks, daily glycemic profiles, and variability tracker). The PAM includes auto suggestions for titration of insulin pump parameters every two weeks (ATM) and is aided by a web simulation tool (WST) which can replay 'what if' scenarios for the participant based on various combinations of insulin pump parameter changes.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CLC, then CLC+BAM, then CLC+ABC
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CLC+ABC, then CLC+BAM, then CLC
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CLC + BAM
Intervention Description
Closed Loop Control with the Behavioral Adaption Module for 4 weeks
Intervention Type
Device
Intervention Name(s)
CLC + ABC
Intervention Description
Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
Primary Outcome Measure Information:
Title
CGM-measured percent time in range 70-180 mg/dL
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
CGM-measured percent above 180 mg/dL during the day
Description
A key secondary outcome is CGM-measured percent above 180mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. If the analysis results in a statistically significant result (p < 0.05), then testing will proceed to the next secondary outcome metric in the following order entered.
Time Frame
4 weeks
Title
CGM-measured percent below 70 mg/dL during the day
Description
A key secondary outcome is CGM-measured percent below 70 mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. If the analysis results in a statistically significant result (p < 0.05), then testing will proceed to the next secondary outcome metric in the following order entered.
Time Frame
4 weeks
Title
CGM-measured mean glucose
Description
A key secondary outcome is CGM-measured mean glucose comparing the last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. If the analysis results in a statistically significant result (p < 0.05), then testing will proceed to the next secondary outcome metric in the following order entered.
Time Frame
4 weeks
Title
CGM-measured coefficient of variation during the day
Description
A key secondary outcome is CGM-measured percent coefficient of variation during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlene Alix
Phone
(434) 249-8961
Email
uax8yx@UVAHealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia McLean
Phone
(434) 466-6744
Email
ohm2eh@UVAHealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Brown, MD
Organizational Affiliation
University of Virginia Center for Diabetes Technology
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sue Brown, MD
Phone
434-982-0602
Email
sab2f@virginia.edu
First Name & Middle Initial & Last Name & Degree
Patricio Colmegna, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Will follow the NIH Data Sharing Policy and Implementation Guidance. Limited deidentified data will be shared while sharing of complete data sets will be regulated by Data-Sharing Agreements.
IPD Sharing Time Frame
Generally following completion of publications.
IPD Sharing Access Criteria
Limited deidentified data will be shared while sharing of complete data sets will be regulated by Data-Sharing Agreements.

Learn more about this trial

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

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