Type 1 Diabetes MellitusNCT04784637
Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery
A study testing Web Simulation Tool (WST), Behavioral Adaptation Module (BAM) and Auto Titration Module (ATM) in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Web Simulation Tool (WST), Behavioral Adaptation Module (BAM) and Auto Titration Module (ATM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2021to 24 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
About this study
Official title: 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).
Read the 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).
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Web Simulation Tool (WST), Behavioral Adaptation Module (BAM), Auto Titration Module (ATM), Automated Insulin Delivery (AID) System
- Keywords
- Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Insulin Pump
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Behavioral Adaptation Module (BAM)Device
BAM provides on-demand information to the participant primarily on glycemic risks.
Auto Titration Module (ATM)Device
ATM provides recommendations to the participant to periodically update insulin parameters.
Automated Insulin Delivery (AID) SystemDevice
The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks Receives: 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 Receives: Device: Web Simulation Tool (WST); Device: Behavioral Adaptation Module (BAM); Device: Auto Titration Module (ATM); Device: Automated Insulin Delivery (AID) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (3)
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.
Measured: 6 weeks
Time in Hypoglycemia
Percent of CGM readings <70 mg/dL
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start23 Jul 2021
- Primary completion24 Dec 2021
- Study completion24 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue Brown, University of Virginia
- Investigators
- Sue Brown, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784637
- Sponsor's protocol ID
- 200336
- Other IDs
- 2R01DK085623-10
- Status last verified
- Oct 2024
- First submitted
- 16 Dec 2020
- Last updated
- 7 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
Publications
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.
PubMed 38662425
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Biobehavioral Control (ABC) of Automated Insulin Delivery: A Randomized, Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT04784637
- Acronym / sponsor ID
- 200336
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Artificial Pancreas (AP), Continuous Glucose Monitor (CGM), Closed Loop Control (CLC), Insulin Pump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 24 Dec 2021 (actual)
- Study completion
- 24 Dec 2021 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Posted 5 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Web Simulation Tool (WST), Device: Auto Titration Module (ATM), Device: Automated Insulin Delivery (AID) SystemAID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks |
| Group 2 | Experimental | Device: Web Simulation Tool (WST), Device: Behavioral Adaptation Module (BAM), Device: Auto Titration Module (ATM), Device: Automated Insulin Delivery (AID) SystemAID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Group 1, Group 2 |
| Behavioral Adaptation Module (BAM)BAM provides on-demand information to the participant primarily on glycemic risks. | Device | Group 2 |
| Auto Titration Module (ATM)ATM provides recommendations to the participant to periodically update insulin parameters. | Device | Group 1, Group 2 |
| Automated Insulin Delivery (AID) SystemThe t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study. | Device | Group 1, Group 2 |
Primary outcome
Number of SAE or ADE Related to the Use of ATM / WST and BAM Modules.
Time frame: 6 weeks
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.
3 secondary outcomes
Time in Range
Time frame: 6 weeks
Time in Hypoglycemia
Time frame: 6 weeks
INSPIRE Questionnaire
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38662425Colmegna 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.
- Individual participant dataSharing planned: Yes. Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sue Brown, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web Simulation Tool (WST), Behavioral Adaptation Module (BAM) and Auto Titration Module (ATM) in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of SAE or ADE Related to the Use of ATM / WST and BAM Modules. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04784637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.