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Type 1 DiabetesNCT07039617

A Randomized Parallel Clinical Trial of AIDANET, an Automated Insulin Delivery Algorithm, in Fully Closed-Loop Vs Hybrid Closed-Loop Mode In Adults With Type 1 Diabetes (AIDANET At Home)

A study testing AIDANET + FCL, AIDANET + HCL and AIDANET in FCL-HCL-mixed mode in people with Type 1 Diabetes, run by Sue Brown at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A randomized cross-over trial assessing glycemic control on Automated insulin delivery as Adaptive Network (AIDANET) algorithm when used in three modes: AIDANET-Fully Closed Loop (FCL), AIDANET-Hybrid Closed Loop (HCL) and AIDANET allowing a mix between FCL and HCL. 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?
AIDANET + FCL, AIDANET + HCL and AIDANET in FCL-HCL-mixed mode
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
2 Sep 2025to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Food and Drug Administration (FDA) approved AID system within the last six months (can be intermittent use).
  • Currently using insulin for at least six months.
  • Willingness to switch to use an FDA-approved personal insulin for the study pump (e.g., lispro or aspart, or biosimilar FDA-approved products) 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 who 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 participants 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 wear a Dexcom CGM during each of the four study phases.
  • Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods.
  • 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 in person training.
  • 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 verbal communication in English.

Who cannot join

  • Plans to start a new non-insulin glucose-lowering agent (e.g. glucagon-like peptide-1 (GLP-1) receptor agonists, Symlin, (DPP-4 inhibitors, also known as dipeptidyl peptidase 4). Participants may be on a stable dose of such an agent for at least the past month.
  • Current use of sulfonylurea medications.
  • Current use of an Sodium-Glucose Cotransporter 2 (also known as a SGLT-2 or SGLT-1/2 inhibitor) due to risk of euglycemic diabetic ketoacidosis (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.
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  • Currently on peritoneal or hemodialysis.
  • Currently being treated for adrenal insufficiency.
  • Currently being treated for a seizure disorder.
  • Hypothyroidism or hyperthyroidism is not adequately treated.
  • Use of oral or injectable steroids at the time of enrollment.
  • 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 at work/school who is 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

A randomized cross-over trial assessing glycemic control on Automated insulin delivery as Adaptive Network (AIDANET) algorithm when used in three modes: AIDANET-Fully Closed Loop (FCL), AIDANET-Hybrid Closed Loop (HCL) and AIDANET allowing a mix between FCL and HCL. There will be an Automated Insulin Delivery (AID) phase with participants using their home devices and/or study continuous glucose monitor (CGM) and study-provided commercial Mobi system without AIDANET.

Read the detailed description

This study is a randomized cross-over trial comparing AIDANET used in three different modalities to currently available AID systems (usual care). For two 4-week phases the participants will first use the system in predetermined modality (HCL or FCL) in random order. The AIDANET system is designed to work both in full closed loop (no meal information) and in hybrid closed-loop, with carbohydrate announcement (standard bolus calculator) or easy bolus (announce timing but not carbohydrate amount), as requested by the user. During a third 4-week long phase, all participants will continue to use the system as befits their preferences (no modality will be imposed, and the user is free to go back and forth between modalities). In addition, the participant will spend 4 weeks using a usual care AID system either before the first AIDANET phase (randomization Group A) or after the last AIDANET phase (randomization Group B).

Conditions
Type 1 Diabetes
Being tested
AIDANET + FCL, AIDANET + HCL, AIDANET in FCL-HCL-mixed mode, Automated Insulin Delivery (AID) (usual care)
Keywords
Automated Insulin Delivery (AID), Fully Closed Loop (FCL), Hybrid Closed Loop (HCL), Specifically modified Mobi System, Automated Insulin Delivery as Adaptive NETwork (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.

  • AIDANET + FCLDevice

    All participants will use AIDANET in fully closed loop (FCL) mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.

  • AIDANET + HCLDevice

    All participants will use AIDANET in hybrid closed loop (HCL) mode with instructions to announce all meal boluses using carbohydrate counting or easy bolus during the four weeks. All components of AIDANET will remain active during this phase but BPS in particular is expected to be triggered less often due to meal announcements.

  • AIDANET in FCL-HCL-mixed modeDevice

    All participants will use AIDANET with instructions to choose whether to use fully closed loop (FCL) or hybrid closed loop (HCL) mode with meal announcements (carb counting or easy bolus) per their discretion each day.

  • Automated Insulin Delivery (AID) (usual care)Other

    Participants will manage their diabetes as they normally do at home.

Study groups in NCT07039617
Study groupRoleWhat they receive
Group AExperimentalGroup A: AID first followed by AIDANET-FCL, AIDANET-HCL and then AIDANET-FCL-HCL mix
Receives: Device: AIDANET + FCL; Device: AIDANET + HCL; Device: AIDANET in FCL-HCL-mixed mode; Other: Automated Insulin Delivery (AID) (usual care)
Group BExperimentalGroup B: AIDANET-FCL first followed by AIDANET-HCL, AIDANET- FCL-HCL mix and AID
Receives: Device: AIDANET + FCL; Device: AIDANET + HCL; Device: AIDANET in FCL-HCL-mixed mode; Other: Automated Insulin Delivery (AID) (usual care)

What is being measured

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

  1. Time in Range (70-180 mg/dL)

    • Computed as the number of estimated glucose values ≥70mg/dL and <180mg/dL divided by the number of valid values (defined as a number between 39 and 401)
    • Outcome is computed if:
    • >4032 values are recorded (availability condition, 2 weeks equivalent)
    • AND there is >70% values between the first recorded EGV of the analysis window and the last (density condition)

    Measured: 16 weeks

Timeline

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

  1. First posted26 Jun 2025
  2. Study start2 Sep 2025
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07039617
Sponsor's protocol ID
302656
Other IDs
5R01DK129553
Status last verified
Sep 2026
First submitted
17 Jun 2025
Last updated
16 Sep 2026
Results posted
No
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.

Questions about this trial

What is this clinical trial studying?

A study testing AIDANET + FCL, AIDANET + HCL and AIDANET in FCL-HCL-mixed mode 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 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 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?

This study is still under way. Results are not available in the source record yet.

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?

Time in Range (70-180 mg/dL) (time frame: 16 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 NCT07039617.

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 16 Sep 2026.

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