Discussion
hyperglycemia, 80%–94, T1D
HYPOGLYCEMIA, HYPERGLYCEMIA
In the present study, time in AHCL and CGM use were high for the pediatric and adult groups using the MM780G+G4S in the CAS and real-world cohorts. The CAS cohort demonstrated 3-month mean A1C that averaged 7.0% and had slightly lower mean SG, CV of SG, percentage of time spent above range (%TAR), and %TBR, with slightly increased TIR, relative to their respective age group in the real-world cohort. Adults met most consensus recommended glycemic targets for AID,While the pediatric groups had very low exposure to hypoglycemia, they did not achieve consensus targets for mean SG, CV of SG, %TAR >180 mg/dL, and %TAR >250 mg/dL. Reasons for this may have been due to modifiable system settings. For instance, in the pediatric CAS cohort, only 28.4% (The Petrovski et al., 3-month RCT, recently reported on the impact of the 100 mg/dL GT (94% of participants) and 2 h AIT (80%–94% of participants) in individuals aged 12–18 years with T1D.The Petrovski et al. findings and the present study pediatric outcomes, where Auto Correction insulin averaged 19% of TDD and 31% of total bolus, shed light on how ICR adjustments and specific modifiable settings inherent to AID therapy can help children and adolescents who may have difficulty managing hyperglycemia when compared to adults. As previously reported,The GS3 was the first glucose sensor approved for AID therapy.Regarding real-world safety of the MM780G+G4S, the 7.8 min/day and 4.8 min/day at %TBR <54 mg/dL for younger and older users, respectively, indicate very low exposure to level 2 hypoglycemia. A recent modeling analysis based on pivotal trial participants, real-world system users and simulated virtual patients transitioning from GS3 to G4S ascertained the clinical impact of that transition.In addition to the MM780G+G4S glycemic benefits observed in the CAS and real-world cohorts, T1D management burden was reduced. A limitation of the present study is that CAS data were collected prospectively and real-world data were retrospectively assessed, which prevented statistical comparative analyses. The study population difference added to this, as the CAS cohort involved clinical trial-enrolled participants with known medical history, AID system experience, follow-up, and moderate glycemic control at baseline (A1C of 7.5% ± 0.8%). In contrast, and while representing potentially generalized outcomes, the larger real-world cohort from multiple countries had no known demographic, medical history, or clinical laboratory follow-up information. Study strengths include timely access to MM780G+G4S for the CAS cohort, in addition to pediatric and adult real-world MM780G system users having automatic data uploading capability through the MiniMed™ smartphone application. This allowed visualization of clinical outcomes and system interactions alongside those of real-world system users.