Type 1 DiabetesABC-WITNCT05610111
Adaptive Biobehavioral Control (ABC) in a Closed-Loop System
A study testing CLC + BAM and CLC + ABC in people with Type 1 Diabetes, run by Sue Brown at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- CLC + BAM and CLC + ABC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to 28 Sep 2024
- 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 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).
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- 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
Who cannot join
- 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
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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) in a Closed-Loop System: A Randomized Crossover Clinical Trial
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).
Read the 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.
- Conditions
- Type 1 Diabetes
- Being tested
- CLC + BAM, CLC + ABC
- Keywords
- Type 1 Diabetes, Closed-Loop Control (CLC), Continuous Glucose Monitoring (CGM), Artificial Pancreas (AP), Tandem t:slim Insulin Pump with Control-IQ Technology
- 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.
CLC + BAMDevice
Closed Loop Control with the Behavioral Adaption Module for 4 weeks
CLC + ABCDevice
Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: CLC + BAM; Device: CLC + ABC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
Secondary outcomes (17)
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.
Measured: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
CGM-measured Percent Below 70 mg/dL During the Day
A key secondary outcome is CGM-measured percent below 70mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone.
Measured: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
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.
Measured: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
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.
Measured: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
Time in Range (70-140 mg/dL)
A key secondary outcome is CGM-measured time in range from 70-140 mg/dL comparing the last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone.
Measured: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
TIR <60 mg/dL
Time below 60 mg/dL as measured by CGM.
Measured: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
Low Blood Glucose Index (LBGI)
The low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values <1 suggest low risk of hypoglycemia.
Measured: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
High Blood Glucose Index (HBGI)
The high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk.
Measured: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
TIR >250 mg/dL
Time above 250 mg/dL as measured by CGM.
Measured: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
TIR >300 mg/dL
Time above 300 mg/dL as measured by CGM.
Measured: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
HbA1c (%) at End of Study
The percentage of glycated hemoglobin. A higher percentage indicates a worse outcome.
Measured: Labs taken at the completion of study, approximately 6 months after enrollment; hence, results are stratified only by arm and not by intervention.
Technology Expectations Survey
This questionnaire is rated on a 5-point Likert scale and is the baseline version of the Technology Acceptance Survey. Technology Expectations and Technology Experience Survey have identical items, except future tense is used in the Technology Expectations Survey (administered at randomization), while past tense is used in the Technology Experience Survey (administered at the end of each intervention). These surveys yield two subscale scores (burdens and benefits); the score of the items in the burden subscale are inverted before averaging the score of all the items to obtain the total technology acceptance reported here (range: 1-5, with 5 indicating higher acceptance).
Measured: Participant baseline
Clarke's Hypoglycemia Awareness Scale
Number of individuals with hypoglycemia awareness, reduced hypoglycemia awareness, and in between, based on Clarke's Hypoglycemia Awareness Scale.
Measured: 22 weeks
Technology Experience Survey
This questionnaire is rated on a 5-point Likert scale and is the endpoint version of the Technology Acceptance Survey. Technology Expectations and Technology Experience Survey have identical items, except future tense is used in the Technology Expectations Survey (administered at randomization), while past tense is used in the Technology Experience Survey (administered at the end of each intervention). These surveys yield two subscale scores (burdens and benefits); the score of the items in the burden subscale are inverted before averaging the score of all the items to obtain the total technology acceptance reported here (range: 1-5, with 5 indicating higher acceptance). The score is not reported for CLC only, as no technology was used during this intervention.
Measured: At participant completion, approximately 6 months
High Blood Glucose Levels Survey
This questionnaire evaluates generalized avoidance of hyperglycemia across 4 subcategories using items rated on a 5-point Likert scale. Range is 1-5, with 5 indicating higher hyperglycemia avoidance and worry. The total score reported is obtained by averaging the scores of all the items in the survey.
Measured: 22 weeks
Hypoglycemia Fear Survey
This questionnaire evaluates Fear of Hypoglycemia and each item is rated on a 5-point Likert scale. Range is 1-5, with 5 indicating higher hypoglycemia fear and worry. The total score reported is obtained by averaging the scores of all the items in the survey.
Measured: 22 weeks
Diabetes Distress Scale
A questionnaire evaluating different domains of diabetes-related distress. Each item is scored on a 6 point Likert scale. Range is 1-6- with scores of 2-2.9 indicating moderate distress and scores > 3.0 indicating severe distress. The total score reported is obtained by averaging the scores of all the items in the survey.
Measured: 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start18 Jan 2023
- Primary completion26 Sep 2024
- Study completion28 Sep 2024
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 DiabetesStudies of the same condition, open and under way.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sue Brown
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tandem Diabetes Care, Inc.
- Responsible party
- Sponsor-investigator, Sue Brown, University of Virginia
- Investigators
- Sue Brown, MD, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610111
- Sponsor's protocol ID
- 220300
- Other IDs
- 2R01DK085623
- Acronym
- ABC-WIT
- Status last verified
- Apr 2026
- First submitted
- 2 Nov 2022
- Last updated
- 7 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40329052
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Biobehavioral Control (ABC) in a Closed-Loop System: A Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT05610111
- Acronym / sponsor ID
- ABC-WIT / 220300
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Sue BrownUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tandem Diabetes Care, Inc.
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 28 Sep 2024 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Posted 7 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLC, then CLC+BAM, then CLC+ABC | Active comparator | Device: CLC + BAM, Device: CLC + ABCParticipants 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. |
| CLC+ABC, then CLC+BAM, then CLC | Active comparator | Device: CLC + BAM, Device: CLC + ABCParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 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 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| CLC + BAMClosed Loop Control with the Behavioral Adaption Module for 4 weeks | Device | CLC+ABC, then CLC+BAM, then CLC, CLC, then CLC+BAM, then CLC+ABC |
| CLC + ABCClosed Loop Control with Adaptive Biobehavioral Control for 16 weeks | Device | CLC+ABC, then CLC+BAM, then CLC, CLC, then CLC+BAM, then CLC+ABC |
Primary outcome
CGM-measured Percent Time in Range 70-180 mg/dL
Time frame: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
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.
17 secondary outcomes
CGM-measured Percent Above 180 mg/dL During the Day
Time frame: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
CGM-measured Percent Below 70 mg/dL During the Day
Time frame: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
CGM-measured Mean Glucose
Time frame: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
CGM-measured Coefficient of Variation During the Day
Time frame: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
Time in Range (70-140 mg/dL)
Time frame: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
TIR <60 mg/dL
Time frame: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
Low Blood Glucose Index (LBGI)
Time frame: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
High Blood Glucose Index (HBGI)
Time frame: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
TIR >250 mg/dL
Time frame: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
TIR >300 mg/dL
Time frame: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC
HbA1c (%) at End of Study
Time frame: Labs taken at the completion of study, approximately 6 months after enrollment; hence, results are stratified only by arm and not by intervention.
Technology Expectations Survey
Time frame: Participant baseline
Clarke's Hypoglycemia Awareness Scale
Time frame: 22 weeks
Technology Experience Survey
Time frame: At participant completion, approximately 6 months
High Blood Glucose Levels Survey
Time frame: 22 weeks
Hypoglycemia Fear Survey
Time frame: 22 weeks
Diabetes Distress Scale
Time frame: 22 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40329052Kovatchev 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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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 Center for Diabetes Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLC + BAM and CLC + ABC in people with Type 1 Diabetes, run by Sue Brown 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 15 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 Jul 2026. 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 7 Jul 2026). 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?
CGM-measured Percent Time in Range 70-180 mg/dL (time frame: 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC). 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 NCT05610111, 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 Jul 2026.