Early Glycemic Outcomes of Pediatric and Adult Users of the MiniMed™ 780G System with the Guardian™ 4 Sensor

The MiniMed™ advanced hybrid closed-loop (AHCL) pivotal trial used an investigational system (MiniMed™ 670G, version 4.0) with the Guardian™ sensor 3 glucose sensor that required a minimum of 2 calibrations/day and an adjunctive blood glucose (BG) measurement for bolus administration. Herein, we report the interim analysis of the continued access study (CAS) phase of the trial where participants transitioned to the MiniMed™ 780G system with the Guardian™ 4 sensor, which requires no calibrations and is non-adjunctive (i.e., sensor glucose, rather than BG, is used for bolus administration).

Methods:

Pediatric (N=109, 7-17yrs) and adult (N=67, 18-75yrs) AHCL trial participants transitioned to the commercial version of the Conformitè Europëenne (CE)-marked MiniMed™ 780G system with the Guardian™ 4 sensor, which does not require calibration. The MiniMed™ 780G system with the Guardian™ sensor 3 has been available in Europe for over one year and the CE-marked Guardian™ 4 sensor has been available for use with the MiniMed™ 780G system since October 2021. Safety events, system use and glycemic outcomes (e.g., mean sensor glucose [SG], coefficient of variation [CV] of SG, and percentage of time in SG ranges) of the CAS phase of the trial were collected over three months.

Results:

MiniMed™ 780G system use for 13,980 days (Pediatric: 8,853 days, Adult: 5,127 days) and time spent in closed loop of 91.0% (Pediatric: 91.4%, Adult: 90.4%) resulted in an overall mean SG of 152 mg/dL (Pediatric: 154 mg/dL, Adult: 148 mg/dL, a TIR (70-180 mg/dL) of 72.8% (Pediatric: 70.7%, Adult: 76.3%), a TBR < 70 mg/dL of 1.9% (Pediatric: 2.2%, Adult: 1.6%), a TBR < 54 mg/dL of 0.4% (Pediatric: 0.4%, Adult: 0.3%) and a TAR >180 mg/dL of 25.2% (Pediatric: 27.1%, Adult: 22.1%). Most glycemic metrics and the overall CV of 34.8% (Pediatric: 36.5%, Adult: 32.2%) met international consensus recommended goals. There were no diabetic ketoacidosis or severe hypoglycemic events.

Discussion/Conclusion:

Interim findings indicate that pediatric and adult CAS participants using the MiniMed™ 780G system with the non-adjunctive Guardian™ 4 sensor safely achieved glycemic control and with significant time in closed loop, similar to findings observed in the AHCL pivotal trial using the investigational system with the adjunctive Guardian™ sensor 3.