Glycemic Outcomes of Twiist™ Automated Insulin Delivery System in People with Diabetes Requiring Insulin, A Large Real-World Study.

Background

Automated insulin delivery (AID) systems are recommended for individuals with diabetes requiring insulin. Real-world effectiveness may differ from outcomes reported in prospective clinical trials. The twiist™ AID system recently received regulatory clearance, and real-world glycemic outcomes have not been previously described.

Methods

This was an ongoing retrospective, observational real-world study with cross-sectional analyses of participant-level summary data. The analysis included individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) who initiated use of the twiist AID system and consented to data sharing. Deidentified continuous glucose monitoring (CGM) and insulin delivery data were analyzed. Inclusion in the analysis required ≥14 days of device use. Glycemic outcomes were assessed using standard CGM metrics, including percent time in range (%TIR; 70-180 mg/dL), time in tight range (%TITR; 70-140 mg/dL), time below range (%TBR; 54 to <70 and <54 mg/dL), and time above range (%TAR; >180-250 and >250 mg/dL). Subgroup analyses evaluated associations with baseline glycated hemoglobin (HbA1c), age, and bolus frequency.

Results

Data from 4000 individuals were included. The duration of device use ranged from a minimum of 14 days to a maximum of 365 days. Mean overall %TIR was 73.5 ± 14.5%, with overnight %TIR of 77.9 ± 16.5%. Hypoglycemia exposure was low, with mean overall %TBR of 54 to <70 mg/dL of 1.9 ± 2.0% and <54 mg/dL of 0.2 ± 0.4%. Glycemic outcomes were generally within recommended targets across age categories except for %TIR among those <18 years of age. Among those with baseline HbA1c values and TIR values (n = 1131), %TIR was 81.5 ± 10.2% and 71.1 ± 11.4%, and 61.7 ± 16.3% for those HbA1c <7%, 7%-8%, and >8%, respectively. More frequent boluses were associated with improved glycemic outcomes.

Conclusions

In this large real-world cohort, use of the twiist AID system was associated with effective overall and overnight glycemic management and minimal hypoglycemia.