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RecruitingType 1 Diabetes

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)

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

No

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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.

Sponsor: Sue Brown

You may qualify if…

  • ✓ 1. Age ≥18.0 years old at time of consent
  • ✓ 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.

You may not qualify if…

  • ✕ 1. 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.
  • ✕ 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.

Where it's recruiting

Virginia

Charlottesville

Source: ClinicalTrials.gov · NCT07039617 · last updated 2026-04-02