Type 1 DiabetesAIDANET+BPS_RLNCT06728059

Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm

A study testing Automated Insulin Delivery Adaptive NETwork (AIDANET) and AIDANET+ BPS_RL→AIDANET in people with Type 1 Diabetes, run by Sue Brown at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A randomized crossover trial assessing glycemic control using Reinforcement Learning trained Bolus Priming System (BPS_RL) added to the the Automated Insulin Delivery as Adaptive NETwork (AIDANET algorithm) compared to the original AIDANET algorithm. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 1 Diabetes
What is being tested?: Automated Insulin Delivery Adaptive NETwork (AIDANET) and AIDANET+ BPS_RL→AIDANET
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 5 Feb 2025to 14 May 2025
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥18.0 years old at time of consent
Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes for at least one year.
Having used an AID system equipped with Dexcom G6 or G7 CGM within the last three months (does not need to be continuous use if CGM was unavailable for instance).
Currently using insulin for at least six months.
Willingness to switch to use a commercially approved personal insulin (e.g., lispro or aspart, or biosimilar approved products) within the study pump as directed by the study team.
Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency.

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Participant not currently known to be pregnant or breastfeeding.
If participant capable of becoming pregnant, must agree to use a form of contraception to prevent pregnancy while a participant in the study (e.g. hormonal contraception, abstinence from heterosexual intercourse). 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 the study AIDANET system (CGM, pump, and phone) during the study period.
Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
Willingness to participate in all study procedures including the house/hotel sessions.
Access to internet at home and willingness to upload data during the study as needed.
Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
Participant is proficient in reading and writing English.

Who cannot join

Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors, sulfonylureas). Participants may be on a stable dose of such an agent for at least the past month.
Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA.
Hemophilia or any other bleeding disorder.
History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.
History of DKA event in the last 12 months.
Stage 4 chronic renal disease or currently on peritoneal or hemodialysis.

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Currently being treated for adrenal insufficiency.
Currently being treated for a seizure disorder.
Hypothyroidism or hyperthyroidism that is not adequately treated.
Use of oral or injectable steroids at the time of enrollment or within the last 4 weeks.
Planned surgery during the study period.
Known ongoing adhesive intolerance that is not well managed.
A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
Participation in another interventional trial at the time of enrollment.
Participant with a direct supervisor involved in the conduct of the trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903

Other trials in United States

About this study

Read the detailed description

After receiving training on the study equipment, participants will use the AIDANET system at home for 7 days/6 nights to establish a baseline and initialize the control algorithm. Participants will then be studied at a hotel session for 3 days/2 nights. Participants will transition to home use of AIDANET+ BPS_RL for 7 days/6 nights.

Conditions: Type 1 Diabetes
Being tested: Automated Insulin Delivery Adaptive NETwork (AIDANET), AIDANET+ BPS_RL→AIDANET
Keywords: Type 1 Diabetes, Automated insulin delivery as Adaptive Network (AIDANET), Diabetes Assistant (DiAs), Fully Closed-Loop, Bolus Priming System (BPS), Remote Learning (RL), Continuous Glucose Monitor (CGM)
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.

Automated Insulin Delivery Adaptive NETwork (AIDANET)Device
Also called AIDANET→AIDANET+ BPS_RL
Group A participants will use the AIDANET system at home for 7 days/6 nights. They will continue use of AIDANET system for 18 hours during the hotel session and then use AIDANET+BPS_RL for 18 hours during the hotel session.
AIDANET+ BPS_RL→AIDANETDevice
Also called Group B
Group B participant will use the AIDANET+BPS_RL system for 18 hours during the hotel session and will then use AIDANET system for 18 hours during the hotel session. They will continue to use AIDANET+BPS_RL system at home for 7 days/6 night and then use the AIDANET system at home for 7 days/6 nights.

Study groups in NCT06728059
Study group	Role	What they receive
AIDANET→AIDANET+ BPS_RL	Active comparator	Group A: AIDANET followed by AIDANET+ BPS_RL during the hotel session Receives: Device: Automated Insulin Delivery Adaptive NETwork (AIDANET)
AIDANET+ BPS_RL→AIDANET	Active comparator	Group B: AIDANET+BPS_RL followed by AIDANET during the hotel session Receives: Device: AIDANET+ BPS_RL→AIDANET

What is being measured

The primary outcome is the main question the study is designed to answer.

CGM-measured Time in Range (TIR, 70-180 mg/dL) During the 18-hour Hotel Sessions.
CGM-measured time in range (TIR, 70-180 mg/dL) during the 18-hour hotel sessions on AIDANET or AIDANET+BPS_RL. The time periods begin at 6 PM and end at noon on the next day, thereby covering two meals - dinner and breakfast.
Measured: 36 hours total (18 hours for Group A and 18 hours for Group B)

Secondary outcomes (3)

CGM-measured Time Below Range <70mg/dL During Hotel Session
CGM-measured Time below range <70mg/dL during the 18-hour hotel session on AIDANET or AIDANET+BPS_RL
Measured: 18 hours
CGM-measured Time in Range (70-180 mg/dL) for At-home
CGM-measured Time in range (70-180 mg/dL) for at-home sessions using AIDANET
Measured: 7 days
CGM-measured Time Below Range 70 mg/dL for At-home
CGM-measured Time below range 70 mg/dL for at-home sessions using AIDANET or AIDANET BPS-RL
Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Feb 202514 May 2025

First posted11 Dec 2024
Study start5 Feb 2025
Primary completion7 May 2025
Study completion14 May 2025

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.
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
Model description: This is a research study about the UVA Automated Insulin Delivery System known as Adaptive NETwork (AIDANET). This system consists of a Reinforcement Learning trained Bolus Priming System (BPS\_RL) added to the AIDANET algorithm and running on Diabetes Assistant (DiAs) phone wirelessly connected to Tandem t:AP insulin pump and Dexcom Continuous Glucose Monitor (CGM). One part of the algorithm, called the Bolus Priming System (BPS), gives insulin automatically to help keep blood sugar levels in a healthy range. In this study, the Bolus Priming System is being tested in a new way. This system uses a type of smart learning called reinforcement learning (RL), which helps the algorithm make better choices about how much insulin to give. The new version of the system looks at blood sugar and insulin levels over the past 3 days to find patterns and give a better insulin dose before meals. This should provide an improvement over the old system, which only uses the last 30 minutes of data.
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06728059
Sponsor's protocol ID: 301989
Other IDs: R01DK133148
Acronym: AIDANET+BPS_RL
Status last verified: May 2026
First submitted: 14 Nov 2024
Last updated: 28 May 2026
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 in the scientific community.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm
ClinicalTrials.gov ID: NCT06728059
Acronym / sponsor ID: AIDANET+BPS_RL / 301989
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes, Automated insulin delivery as Adaptive Network (AIDANET), Diabetes Assistant (DiAs), Fully Closed-Loop, Bolus Priming System (BPS), Remote Learning (RL), Continuous Glucose Monitor (CGM)
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Sue BrownUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), DexCom, Inc.
Study start: 5 Feb 2025 (actual)
Primary completion: 7 May 2025 (actual)
Study completion: 14 May 2025 (actual)
First posted: 11 Dec 2024 (actual)
Results: Posted 28 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: This is a research study about the UVA Automated Insulin Delivery System known as Adaptive NETwork (AIDANET). This system consists of a Reinforcement Learning trained Bolus Priming System (BPS_RL) added to the AIDANET algorithm and running on Diabetes Assistant (DiAs) phone wirelessly connected to Tandem t:AP insulin pump and Dexcom Continuous Glucose Monitor (CGM). One part of the algorithm, called the Bolus Priming System (BPS), gives insulin automatically to help keep blood sugar levels in a healthy range. In this study, the Bolus Priming System is being tested in a new way. This system uses a type of smart learning called reinforcement learning (RL), which helps the algorithm make better choices about how much insulin to give. The new version of the system looks at blood sugar and insulin levels over the past 3 days to find patterns and give a better insulin dose before meals. This should provide an improvement over the old system, which only uses the last 30 minutes of data.

Arm	Type	Receives
AIDANET→AIDANET+ BPS_RL	Active comparator	Device: Automated Insulin Delivery Adaptive NETwork (AIDANET)Group A: AIDANET followed by AIDANET+ BPS_RL during the hotel session
AIDANET+ BPS_RL→AIDANET	Active comparator	Device: AIDANET+ BPS_RL→AIDANETGroup B: AIDANET+BPS_RL followed by AIDANET during the hotel session

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Age ≥18.0 years old at time of consent
Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes for at least one year.
Having used an AID system equipped with Dexcom G6 or G7 CGM within the last three months (does not need to be continuous use if CGM was unavailable for instance).
Currently using insulin for at least six months.
Willingness to switch to use a commercially approved personal insulin (e.g., lispro or aspart, or biosimilar approved products) within the study pump as directed by the study team.

Key exclusion criteria (15 listed)

Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors, sulfonylureas). Participants may be on a stable dose of such an agent for at least the past month.
Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA.
Hemophilia or any other bleeding disorder.
History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.
History of DKA event in the last 12 months.

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
Automated Insulin Delivery Adaptive NETwork (AIDANET)Also: AIDANET→AIDANET+ BPS_RLGroup A participants will use the AIDANET system at home for 7 days/6 nights. They will continue use of AIDANET system for 18 hours during the hotel session and then use AIDANET+BPS_RL for 18 hours during the hotel session.	Device	AIDANET→AIDANET+ BPS_RL
AIDANET+ BPS_RL→AIDANETAlso: Group BGroup B participant will use the AIDANET+BPS_RL system for 18 hours during the hotel session and will then use AIDANET system for 18 hours during the hotel session. They will continue to use AIDANET+BPS_RL system at home for 7 days/6 night and then use the AIDANET system at home for 7 days/6 nights.	Device	AIDANET+ BPS_RL→AIDANET

Primary outcome

CGM-measured Time in Range (TIR, 70-180 mg/dL) During the 18-hour Hotel Sessions.
Time frame: 36 hours total (18 hours for Group A and 18 hours for Group B)
CGM-measured time in range (TIR, 70-180 mg/dL) during the 18-hour hotel sessions on AIDANET or AIDANET+BPS_RL. The time periods begin at 6 PM and end at noon on the next day, thereby covering two meals - dinner and breakfast.

3 secondary outcomes

CGM-measured Time Below Range <70mg/dL During Hotel Session
Time frame: 18 hours
CGM-measured Time in Range (70-180 mg/dL) for At-home
Time frame: 7 days
CGM-measured Time Below Range 70 mg/dL for At-home
Time frame: 1 week

Results and safety

Results posted to the registry on 28 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AIDANET→AIDANET+ BPS_RL	8	8
AIDANET+ BPS_RL→AIDANET	7	7

Primary outcome: CGM-measured Time in Range (TIR, 70-180 mg/dL) During the 18-hour Hotel Sessions.

Time frame: 36 hours total (18 hours for Group A and 18 hours for Group B). Mean (Standard Deviation). Unit: percentage of time

Measure	AIDANET With BPRL n = 12	AIDANET n = 12
Value	85.7 (8.7)	86.5 (10)

AIDANET With BPRL vs AIDANET: Mean Difference (Final Values): -0.92, p = 0.047, Mixed Models Analysis

Population analysed: 12 instead of 15 are included here because 3 participants had a software error that did not allow evaluation in this part of the study, primarily due to changes in meals

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected for the 3 weeks participated in the clinical trial - Visit 2 AIDANET training through the completion of visit 8 - post-study check in visit.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AIDANET	0 of 15 (0%)	0 of 15 (0%)	0 of 15
AIDANET BPS_RL	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 in 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 Automated Insulin Delivery Adaptive NETwork (AIDANET) and AIDANET+ BPS_RL→AIDANET 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 14 inclusion and 15 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 28 May 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 28 May 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 Time in Range (TIR, 70-180 mg/dL) During the 18-hour Hotel Sessions. (time frame: 36 hours total (18 hours for Group A and 18 hours for Group B)). 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 NCT06728059.

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 28 May 2026.