Type 1 DiabetesNCT07020936
AIDANET Pediatrics
A study testing Normal Glycemia Goal and Tight Glycemia Goal in people with Type 1 Diabetes, run by Mark D. DeBoer, MD, MSc., MCR at 3 sites in United States.
Trial summary
AIDANET algorithm with smart-phone based control system (study smart phone), specifically modified Tandem insulin system (study insulin pump), and Dexcom G6 CGM (study CGM). Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Normal Glycemia Goal and Tight Glycemia Goal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Jul 2025to 31 Oct 2026
- 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 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥6.0 and ≤13 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 use lispro/aspart in the insulin pump during the study.
- Currently using a Dexcom G6 or G7 CGM.
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- Has one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that live with participant.
- 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 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 Diabetic ketoacidosis (DKA).
- Hemophilia or any other bleeding disorder.
- History of severe hypoglycemic events with seizure or loss of consciousness in the last 6 months.
- History of diabetic ketoacidosis (DKA) event in the last 6 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
3 sites in 1 country.
United States3 sites
Barbara Davis Center, University of Colorado
Aurora, Colorado, 80045
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
University of California San Francisco
San Francisco, California, 94158
About this study
Official title: Safety and Feasibility Testing of AIDANET in Children Age 6-13 Years
AIDANET algorithm with smart-phone based control system (study smart phone), specifically modified Tandem insulin system (study insulin pump), and Dexcom G6 CGM (study CGM).
Read the detailed description
This study aims to demonstrate the safety and feasibility of the Automated insulin delivery as Adaptive NETwork (AIDANET) system among children age 6-13 years. This includes use of new features allowing requested correction boluses and setting a tighter glycemia goal.
- Conditions
- Type 1 Diabetes
- Being tested
- Normal Glycemia Goal, Tight Glycemia Goal
- Keywords
- Adaptive NETwork (AIDANET) system, Fully Closed Loop (FCL), Specifically modified Mobi system
- 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.
Normal Glycemia GoalDevice
Participants will use the normal AIDANET system aggressivity adjustment to achieve target glucose for both the hotel and AIDANET at home periods.
Tight Glycemia GoalDevice
Participants will have the AIDANET system controller target set to have higher aggressivity adjustment to maintain target glucose for both the hotel and AIDANET at home periods.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care before experimental system; system with Normal Glycemia Goal | Other | Participants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Normal Glycemia Goal. Receives: Device: Normal Glycemia Goal |
| Usual Care before experimental system; system with Tight Glycemia Goal | Other | Participants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Tight Glycemia Goal. Receives: Device: Tight Glycemia Goal |
| Usual Care after experimental system; system with Normal Glycemia Goal | Other | Participants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Normal Glycemia Goal. Receives: Device: Normal Glycemia Goal |
| Usual Care after experimental system; system with Tight Glycemia Goal | Other | Participants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Tight Glycemia Goal. Receives: Device: Tight Glycemia Goal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of mean CGM between FCL and Usual Care
Non-inferiority of the mean CGM between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Measured: 28 days
Secondary outcomes (9)
GMI derived from mean CGM
Non-inferiority of GMI derived from the mean CGM between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Measured: 28 days
Time in range 70-180 mg/dL
Non-inferiority of time in range 70-180 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Measured: 28 days
CGM standard deviation (StDev)
Non-inferiority of CGM standard deviation (StDev) between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Measured: 28
CGM coefficient of variation (CV)
Non-inferiority of CGM coefficient of variation (CV) between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Measured: 28 days
CGM %<54 mg/dL
Non-inferiority of CGM %<54 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Measured: 28 days
CGM %<70 mg/dL
Non-inferiority of CGM %<70 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Measured: 28 days
CGM %>180 mg/dL
Non-inferiority of CGM %>180 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Measured: 28 days
CGM %>250 mg/dL
Non-inferiority of CGM %>250 mg/dL between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
Measured: 28 days
Non-inferiority of mean CGM between Normal Glycemia Goal and Tight Glycemia Goal
Mean CGM and other outcomes listed above will be assessed between Normal Glycemia Goal and Tight Glycemia Goal groups
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start21 Jul 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 study is a randomized crossover, device safety/feasibility trial with a supervised house/hotel with transition to home use, interventional trial of AIDANET.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mark D. DeBoer, MD, MSc., MCR
- Sponsor type
- University, hospital or other
- Collaborators
- Tandem Diabetes Care, Inc., DexCom, Inc.
- Responsible party
- Sponsor-investigator, Mark D. DeBoer, MD, MSc., MCR, University of Virginia
- Investigators
- Mark DeBoer, MD, Study chair, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020936
- Sponsor's protocol ID
- 302210
- Status last verified
- May 2026
- First submitted
- 27 May 2025
- Last updated
- 1 Jun 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility Testing of AIDANET in Children Age 6-13 Years
- ClinicalTrials.gov ID
- NCT07020936
- Acronym / sponsor ID
- 302210
- Conditions
- Type 1 Diabetes
- Keywords
- Adaptive NETwork (AIDANET) system, Fully Closed Loop (FCL), Specifically modified Mobi system
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Mark D. DeBoer, MD, MSc., MCRUniversity, hospital or other
- Collaborators
- Tandem Diabetes Care, Inc., DexCom, Inc.
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
AIDANET algorithm with smart-phone based control system (study smart phone), specifically modified Tandem insulin system (study insulin pump), and Dexcom G6 CGM (study CGM).
Detailed description
This study aims to demonstrate the safety and feasibility of the Automated insulin delivery as Adaptive NETwork (AIDANET) system among children age 6-13 years. This includes use of new features allowing requested correction boluses and setting a tighter glycemia goal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study is a randomized crossover, device safety/feasibility trial with a supervised house/hotel with transition to home use, interventional trial of AIDANET.
| Arm | Type | Receives |
|---|---|---|
| Usual Care before experimental system; system with Normal Glycemia Goal | Other | Device: Normal Glycemia GoalParticipants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Normal Glycemia Goal. |
| Usual Care before experimental system; system with Tight Glycemia Goal | Other | Device: Tight Glycemia GoalParticipants will complete two weeks Usual Care Control Period before the use of the AIDANET system, with system employing Tight Glycemia Goal. |
| Usual Care after experimental system; system with Normal Glycemia Goal | Other | Device: Normal Glycemia GoalParticipants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Normal Glycemia Goal. |
| Usual Care after experimental system; system with Tight Glycemia Goal | Other | Device: Tight Glycemia GoalParticipants will complete two weeks Usual Care Control Period after the use of the AIDANET system, with system employing Tight Glycemia Goal. |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- Age ≥6.0 and ≤13 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 use lispro/aspart in the insulin pump during the study.
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 Diabetic ketoacidosis (DKA).
- Hemophilia or any other bleeding disorder.
- History of severe hypoglycemic events with seizure or loss of consciousness in the last 6 months.
- History of diabetic ketoacidosis (DKA) event in the last 6 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 |
|---|---|---|
| Normal Glycemia GoalParticipants will use the normal AIDANET system aggressivity adjustment to achieve target glucose for both the hotel and AIDANET at home periods. | Device | Usual Care after experimental system; system with Normal Glycemia Goal, Usual Care before experimental system; system with Normal Glycemia Goal |
| Tight Glycemia GoalParticipants will have the AIDANET system controller target set to have higher aggressivity adjustment to maintain target glucose for both the hotel and AIDANET at home periods. | Device | Usual Care after experimental system; system with Tight Glycemia Goal, Usual Care before experimental system; system with Tight Glycemia Goal |
Primary outcome
Non-inferiority of mean CGM between FCL and Usual Care
Time frame: 28 days
Non-inferiority of the mean CGM between the two weeks of the Usual Care observational period and the two weeks of AIDANET at-home
9 secondary outcomes
GMI derived from mean CGM
Time frame: 28 days
Time in range 70-180 mg/dL
Time frame: 28 days
CGM standard deviation (StDev)
Time frame: 28
CGM coefficient of variation (CV)
Time frame: 28 days
CGM %<54 mg/dL
Time frame: 28 days
CGM %<70 mg/dL
Time frame: 28 days
CGM %>180 mg/dL
Time frame: 28 days
CGM %>250 mg/dL
Time frame: 28 days
Non-inferiority of mean CGM between Normal Glycemia Goal and Tight Glycemia Goal
Time frame: 17 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- 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.
Mark DeBoer, MD study chair
University of Virginia Center for Diabetes Technology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Glycemia Goal and Tight Glycemia Goal in people with Type 1 Diabetes, run by Mark D. DeBoer, MD, MSc., MCR at 3 sites 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: under way, not looking for participants, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Non-inferiority of mean CGM between FCL and Usual Care (time frame: 28 days). 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 1 Jun 2026.