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
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.
• 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.
• 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.