Table 2.

Connected Pens – Clinical Studies.

Study, year	Device	Sample size	Type 1 or type 2 diabetes	Type of trial	Primary outcome	Secondary outcome
Adolfsson (2020) (26)	NovoPen 6	94	T1D	Prospective, proof-of concept study	Time in range (P < 0.001)	Missed bolus doses (P = 0.1352), time above range (P = 0.003), time below range (P = 0.005)
Gomez-Peralta (2020) (30)	Insulclock	16	T1D	Randomized pilot study	Time in range (P = 0.038)	Missed bolus doses, time above range (P = 0.0026), time below range
Jendle (2021) (19)	NovoPen 6	94	T1D	Prospective, proof-of-concept study (continuation of Adolfsson et al. 2020)	Cost-effectiveness, time in range	Mortality, quality of life, time above range, time below range
Vigersky (2021) (28)	InPen	529	T1D or T1D	Observational study	Time in range (P < 0.05)	Time above range, time below range, total insulin doses (all P < 0.05)
Ekberg (2022) (27)	NovoPen 6	32	T1D	Prospective, proof-of-concept study	Missed bolus doses (P < 0.001)	Time in range (P = 0.005), time above range (P = 0.002), time below range (ns)
Galindo (2023) (29)	Insulclock	80	T2D	Randomized, crossover pilot	Missed bolus doses (ns)	A1c (P = 0.006), mean glucose (P <  0.01), treatment satisfaction (ns)
Chien (2023) (20)	InPen	1681	T1D or T2D	Retrospective, real-world analysis	Number of severe hypoglycemia episodes (P = 0.008)	Cost savings
Baliga (2023) (31)	Bigfoot Unity	58	T1D or T2D	Retrospective, real-world analysis	Alc (P < 0.001)	Time in range (P < 0.05), time above range (P < 0.05), time below range, average glucose (P < 0.05)