Pivotal trial continued access study cohort
hypoglycemia, DKA
ADVERSE EVENTS, MAY, HYPOGLYCEMIA, DIABETIC KETOACIDOSIS
The Safety Evaluation of the AHCL System in Type 1 Adult and Pediatric Subjects pivotal trial (NCT03959423) was a multicenter, single-arm, nonrandomized study that investigated safety, change in A1C, and the percentage of time spent in CGM ranges between baseline run-in (without AHCL) and study (with AHCL) in adolescent (aged 14–21 years) and adult (aged ≥22–75 years) participants. The investigational AHCL system included the MiniMed™ 670G insulin pump with version 4.0 algorithm, the adjunctive and calibration-required Guardian™ Sensor 3 (GS3) glucose sensor (Medtronic), Guardian™ Link 3 transmitter (Medtronic), and the CONTOURParticipants who completed the pivotal trial could continue using the investigational system in a prospective continued access study (CAS). For those who entered the CAS, bloodwork for laboratory A1C was conducted at the end of the pivotal trial or at the start of the CAS period. Bloodwork for A1C was conducted, again, at 90-day follow-up visits. System data were also uploaded to CareLink™ Clinical software (Medtronic). Participants and/or their guardians were instructed to continue performing a BGM when prompted by the pump (e.g., for calibration) or when experiencing symptoms that did not align with their SG value. Investigational sites continued to report serious adverse events, including severe hypoglycemia and diabetic ketoacidosis (DKA), and system settings were adjusted at the discretion of investigators.In May 2021, the MiniMed™ 780G system with Guardian™ 4 Sensor (G4S), Guardian™ Link 4 transmitter and the Accu-Chek