Table 7.

Insulin pen caps.

Study, year	Device studied/device compared	Type of insulin/company	Participants	Study design	Results
Gomez -Peralta F. et al. (2019) (137)	Insulclock®/none	Humulin NPH, Abasaglar, Humalog®, Humalog® Junior, Humalog® Mix25, Humalog® Mix50, and Humalog® 200/Eli Lilly	9 volunteers with T1DM	Performance and functionalities tests	Insulclock® detected seven types of insulin pens with a 97% correct classification rate. Most of the doses were accurately detected (deviation = 0), with relative errors ranging from 3% to 7% across different dosages among 556 injections.
Gomez-Peralta F. et al. (2020) (138)	Insulclock®/standard pen (masked device)	Humalog® KwikPen®/Eli Lilly	16	Randomized, single-center, prospective, open-label, pilot study	Insulclock® led to the decrease in mean glucose (-27.0 mg/dl [1.5 mmol/l]; p = 0.013), glucose standard deviation (SD) (-14.4 mg/dl [0.8 mmol/l]; p = 0.003), and time above range (TAR) (-12.5%, p = 0.0026), and an increase in time in range (TIR) (+7%; p = 0.038) in the overall population.
Galindo et al. (2021) (139)	Insulclock®/standard pen (masked device)	Lantus®/Sanofi-Aventis	80 patients with uncontrolled T2DM on basal insulin	Randomized, 26-week, prospective, crossover, pilot study	Patients in the active phase were characterized by lower mean daily blood glucose (147.0 ± 34 vs. 157.6 ± 42 mg/dl, p < .01) and greater reduction of HbA1c (-0.98% vs. -0.72%, p = .006) but with no significant changes in treatment adherence, insulin omission, and insulin mistiming.