Type 1 DiabetesMiniNETNCT06633965
Safety and Feasibility Testing of a Smaller Network Version of AIDANET
A study testing AIDANET in people with Type 1 Diabetes, run by Marc Breton at 1 site in United States.
Trial summary
A randomized 1:1 crossover trial that intends to demonstrate feasibility and safety of the Automated Insulin Delivery as Adaptive NETwork (AIDANET) system run in a new smaller network version, used in full closed loop (FCL) by adults who have been diagnosed with type 1 diabetes (T1D). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- AIDANET
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2024to 18 Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥18.0 and ≤60 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 three months; Any pump, either open loop or hybrid closed loop may be used.
- 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.
- Currently using a Dexcom G6 or G7 CGM.
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- 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.
- 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 FCL system (CGM, pump, and phone) during the relevant 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 session, exercise challenges (e.g., one hour per day during hotel), and to consume approximately 3 unannounced meals per day during the relevant portion of the supervised hotel session.
- 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.
- History of chronic renal disease (Stage 4 or unstable Stage 3b per investigator judgment) or currently on peritoneal or hemodialysis.
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- History of adrenal insufficiency.
- Currently being treated for a seizure disorder.
- Hypothyroidism or hyperthyroidism that is not adequately treated.
- Coronary artery disease or other heart condition that would prevent participation in moderate intensity exercise.
- 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
Charlottesville, Virginia, 22904
About this study
Official title: Safety and Feasibility Testing of a Smaller Network Version of AIDANET (MiniNET)
A randomized 1:1 crossover trial that intends to demonstrate feasibility and safety of the Automated Insulin Delivery as Adaptive NETwork (AIDANET) system run in a new smaller network version, used in full closed loop (FCL) by adults who have been diagnosed with type 1 diabetes (T1D).
Read the detailed description
The study will be performed for about 36 hours at a local hotel. Following the hotel session, participants will undergo a 7 day/6-night Remote Monitored At-Home use session. A one-week control period gathering data on glycemic control and insulin administration with the participants usual care therapy will also be completed. Participants will be randomized 1:1, to either Group A (control period prior to AIDANET use) or Group B (control period after AIDANET use).
- Conditions
- Type 1 Diabetes
- Being tested
- AIDANET
- Keywords
- Type 1 Diabetes, Meal Boluses, Fully Closed Loop (FCL), AIDANET
- 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.
AIDANETDevice
Also called Group B
AIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions.
AIDANETDevice
Also called Group A
AIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care→AIDANET | Active comparator | Participants will complete 7 days/6 nights at home usual care period using their personal equipment. Participants will then use the AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights. Receives: Device: AIDANET |
| AIDANET→Usual Care | Active comparator | Participants will use AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights and then will complete 7 days/6 nights at home usual care period using their personal equipment. Receives: Device: AIDANET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Mean Continuous Glucose Monitor (CGM) Between the Week of the Usual Care Observational Period and the Week of AIDANET At-Home.
This study represents a small pilot study to assess the safety and efficacy of the small-version AIDANET system and is not formally powered. Nevertheless, the randomized crossover design will allow for analysis of period effects between Group A and Group B. Comparison between these groups will be made to determine if a period effect can explain part of the benefit of the FCL system during the at-home period.
Measured: 2 weeks
Secondary outcomes (3)
Difference in Percent Time-in-range
Difference in percent CGM samples in 70-180 mg/dL between the Week of the Usual Care Observational Period and the Week of AIDANET At-home. Represented as AIDANET minus Usual Care.
Measured: 2 weeks
Difference in Percent Time-below-range
Difference in CGM percent samples < 70mg/dL between the Week of the Usual Care Observational Period and the Week of AIDANET At-home. Represented as AIDANET minus Usual Care.
Measured: 2 weeks
Difference in Percent Time-in-tight-range
Difference in percent CGM samples in 70-140 mg/dL between the Week of the Usual Care Observational Period and the Week of AIDANET At-home. Represented as AIDANET minus Usual Care.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start20 Nov 2024
- Primary completion16 Dec 2024
- Study completion18 Dec 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.
- 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
- Participants will be randomized 1:1 to assess a 1-week usual care period before use of the AIDANET system (Group A) or after use of the AIDANET system (Group B).
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marc Breton
- Sponsor type
- University, hospital or other
- Collaborators
- Tandem Diabetes Care, Inc., DexCom, Inc.
- Responsible party
- Sponsor-investigator, Marc Breton, University of Virginia
- Investigators
- Sue Brown, MD, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633965
- Sponsor's protocol ID
- 301828
- Acronym
- MiniNET
- Status last verified
- Jul 2025
- First submitted
- 4 Oct 2024
- Last updated
- 14 Aug 2025
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Testing of a Smaller Network Version of AIDANET (MiniNET)
- ClinicalTrials.gov ID
- NCT06633965
- Acronym / sponsor ID
- MiniNET / 301828
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Meal Boluses, Fully Closed Loop (FCL), AIDANET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Marc BretonUniversity, hospital or other
- Collaborators
- Tandem Diabetes Care, Inc., DexCom, Inc.
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Posted 14 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized 1:1 crossover trial that intends to demonstrate feasibility and safety of the Automated Insulin Delivery as Adaptive NETwork (AIDANET) system run in a new smaller network version, used in full closed loop (FCL) by adults who have been diagnosed with type 1 diabetes (T1D).
Detailed description
The study will be performed for about 36 hours at a local hotel. Following the hotel session, participants will undergo a 7 day/6-night Remote Monitored At-Home use session. A one-week control period gathering data on glycemic control and insulin administration with the participants usual care therapy will also be completed. Participants will be randomized 1:1, to either Group A (control period prior to AIDANET use) or Group B (control period after AIDANET use).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 to assess a 1-week usual care period before use of the AIDANET system (Group A) or after use of the AIDANET system (Group B).
| Arm | Type | Receives |
|---|---|---|
| Usual Care→AIDANET | Active comparator | Device: AIDANETParticipants will complete 7 days/6 nights at home usual care period using their personal equipment. Participants will then use the AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights. |
| AIDANET→Usual Care | Active comparator | Device: AIDANETParticipants will use AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights and then will complete 7 days/6 nights at home usual care period using their personal equipment. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Age ≥18.0 and ≤60 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 three months; Any pump, either open loop or hybrid closed loop may be used.
- 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 (16 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 |
|---|---|---|
| AIDANETAlso: Group BAIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions. | Device | AIDANET→Usual Care |
| AIDANETAlso: Group AAIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions. | Device | Usual Care→AIDANET |
Primary outcome
Change in the Mean Continuous Glucose Monitor (CGM) Between the Week of the Usual Care Observational Period and the Week of AIDANET At-Home.
Time frame: 2 weeks
This study represents a small pilot study to assess the safety and efficacy of the small-version AIDANET system and is not formally powered. Nevertheless, the randomized crossover design will allow for analysis of period effects between Group A and Group B. Comparison between these groups will be made to determine if a period effect can explain part of the benefit of the FCL system during the at-home period.
3 secondary outcomes
Difference in Percent Time-in-range
Time frame: 2 weeks
Difference in Percent Time-below-range
Time frame: 2 weeks
Difference in Percent Time-in-tight-range
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- 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 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 AIDANET in people with Type 1 Diabetes, run by Marc Breton 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 16 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 14 Aug 2025. 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 14 Aug 2025). 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?
Change in the Mean Continuous Glucose Monitor (CGM) Between the Week of the Usual Care Observational Period and the Week of AIDANET At-Home. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2025.