Demonstrates better insulin management in insulin-treated diabetes users, suggesting enhanced care opportunities.
Introduction and Objective: To analyze the impact of using a connected insulin pen cap (CIPC) on insulin injection timing and glucometrics. Methods: A pragmatic, real-world, multicenter, prospective, observational study, including a one-week run-in, a two-week masked-mode phase, and a four-week active phase. Persons with insulin-treated diabetes (ITD), users of continuous glucose monitoring (CGM) who started using the CIPC Insulclock® providing automatically tracked insulin injection data. The baseline and 5h paired CGM and rapid-acting insulin data collected from Insulclock v2.0® were analyzed using the ROC detection methodology to identify meal events and timing of insulin doses. Results: Of 82 recruited, 52 completed the study (54.4 y, 56.6% women, 60.4% type 1 diabetes, HbA1c: 7.91%) in three hospitals and one primary care center in Spain. The CGM glucometrics comparison between the masked and the active phase showed: Glucose Management Indicator 8.1 ±1.7 vs 7.8 ±1.4 % (p 0.034); Time in Range70-180: 56.9 ±24.5 vs 61.9 ±21.6 % (p 0.0054); Time below range70: 2.5 ±3.3 vs 1.76 ±2.6 % (p 0.0015); Time above range180: 40.9 ±25.3 vs 36.6 ±22.4 % (p 0.016). The timing of insulin injection regarding the post-meal glycemic excursions changed from ± 5.6 min (IQR -19.8 to +34.0) in the masked phase to -5.9 min (IQR -27.6 to ± 33.9) in the active phase (p = 0.023). Conclusion: Insulclock v2.0® CIPC use is associated with improved insulin injection timing and glucometrics. Disclosure F. Gomez-Peralta: Research Support; Ended; Abbott Diabetes, Novo Nordisk. Research Support; Current; Eli Lilly and Company. Speaker's Bureau; Ended; AstraZeneca. Advisory Panel; Current; Insulcloud SL, Sanofi. Speaker's Bureau; Ended; Sanofi. J.B. Guijarro: Speaker's Bureau; Current; AstraZeneca, Dexcom, Inc., Lilly Diabetes. Consultant; Current; Roche Diabetes Care, Ascensia Diabetes Care. R. Corcoy Pla: None. C. Abreu: None. E. Santos Mazo: None. X. Valledor: Research Support; Current; Insulcloud SL. Funding Insulcloud S.L.
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