Improvement in insulin injection timing and glucometrics using a connected insulin cap: the Insulclock v2.0® prospective study
Objectives Matching insulin injection timing with meals to optimize postprandial glucose excursions is a daily challenge for individuals with diabetes on a multiple daily injection (MDI) regimen. We aimed to analyze the impact of using a connected insulin pen cap (CIPC) on insulin injection timing and glycemic control. Research design and methods Pragmatic, real-life, multicenter, prospective, open-label, observational study, including one week of run-in and a 6-week follow-up, split into a two-week masked mode phase and a four-week active phase. Continuous glucose monitoring (CGM) and automatically tracked insulin injection data in individuals with insulin-treated diabetes (ITD) who started using the CIPC Insulclock. The baseline and five hours of paired CGM and rapid-acting insulin data collected from Insulclock v2.0® users were analyzed using the ROC detection methodology to identify meal events and the timing of insulin doses. Results Of 82 recruited patients, 52 completed the study (54.4 y, 56.6% women, 60.4% with type 1 diabetes [T1D]) across three hospitals and one primary care center in Spain. The CGM glucometrics comparison between the consecutive masked and active phases showed: Glucose Management Indicator (GMI) 8.1 + 1.7 vs 7.8 + 1.4% (-0.3%, p 0.034); Time in Range 70-180 (TIR): 56.9 + 24.5 vs 61.9 + 21.6% (+5.0%, p 0.0054); Time below range <70 (TBR70): 2.5 + 3.3 vs 1.76 + 2.6% (-0.74%, p 0.0015); Time above range >180 (TAR180): 40.9 + 25.3 vs 36.6 + 22.4% (-5.3%, p 0.016). The on-time insulin injections increased: 45.5 + 15.52 to 54.4 + 16.6% (p 0.0017). The timing of insulin injection relative to the post-meal glycemic excursions shifted from +5.6 min (IQR –19.8 to +34.0) in the masked phase (n = 231 events) to –5.9 min (IQR –27.6 to +33.9) in the active phase (n = 467 events) (p = 0.023). An earlier injection was associated with a reduction in TAR180 (p = 0.042). Questionnaires measuring patients’ reported outcomes (PROs) indicated a reduction in perceived treatment burden with the use of the Insulclock v2.0® CIPC. Conclusions The use of Insulclock v2.0® connected insulin pen cap is associated with improved insulin injection timing and glucometrics.