Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
40 participants
INTERVENTIONAL
2025-09-02
2026-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
AIDANET Pediatrics
NCT07020936
Safety and Feasibility Testing of a Smaller Network Version of AIDANET
NCT06633965
Fully Closed Loop At Home (FCL@Home)
NCT06041971
Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm
NCT06728059
Insulet Artificial Pancreas Free-Living IDE3
NCT03216460
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A
Group A: AID first followed by AIDANET-FCL, AIDANET-HCL and then AIDANET-FCL-HCL mix
AIDANET + FCL
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 + HCL
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 mode
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)
Participants will manage their diabetes as they normally do at home.
Group B
Group B: AIDANET-FCL first followed by AIDANET-HCL, AIDANET- FCL-HCL mix and AID
AIDANET + FCL
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 + HCL
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 mode
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)
Participants will manage their diabetes as they normally do at home.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AIDANET + FCL
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 + HCL
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 mode
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)
Participants will manage their diabetes as they normally do at home.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes for at least one year.
3. Having used an Food and Drug Administration (FDA) approved AID system within the last six months (can be intermittent use).
4. Currently using insulin for at least six months.
5. 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.
6. 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.
7. Participant not currently known to be pregnant or breastfeeding.
8. 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.
9. Willingness to wear a Dexcom CGM during each of the four study phases.
10. Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods.
11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
12. Willingness to participate in all study procedures including in person training.
13. Access to internet at home and willingness to upload data during the study as needed.
14. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
15. Participant is proficient in reading and verbal communication in English.
Exclusion Criteria
2. Current use of sulfonylurea medications.
3. 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).
4. Hemophilia or any other bleeding disorder.
5. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.
6. History of DKA event in the last 12 months.
7. Currently on peritoneal or hemodialysis.
8. Currently being treated for adrenal insufficiency.
9. Currently being treated for a seizure disorder.
10. Hypothyroidism or hyperthyroidism is not adequately treated.
11. Use of oral or injectable steroids at the time of enrollment.
12. Known ongoing adhesive intolerance that is not well managed.
13. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
14. Participation in another interventional trial at the time of enrollment.
15. Participant with a direct supervisor at work/school who is involved in the conduct of the trial.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tandem Diabetes Care, Inc.
INDUSTRY
DexCom, Inc.
INDUSTRY
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Sue Brown
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sue Brown
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sue Brown, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia Center for Diabetes Technology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
302656
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.