Table 1.
Design Details of the Identified Studies.
| Study reference; countries | Study design (duration) | Study device | Diabetes type (% population) | Study subjects (N) | Aspects of smart/connected pen or device use examined | Assessment tools used |
|---|---|---|---|---|---|---|
| Adolfsson et al 17 ; Canada, Finland, Israel, Sweden | Open-label, observational, multicenter study (12-18 weeks) | Novo Pen Echo | T1DM (100) | Pts (358) | Technical complaints related to adverse reactions, usability, HbA1c | Questionnaire, case report forms |
| Asakura and Jensen 18 ; Japan | Randomized, open-label, crossover (60-90 minutes) | Groups used both Levemir FlexPen and Lantus OptiClik pen | T2DM (100) | Pts (61), split into intuitiveness and instruction time groups | Injection time with and without instruction a , pt preference and usability | Questionnaire |
| Cerna and Maresova 19 ; Czech Republic | Online survey (NA) | None | T1DM (45) T2DM (55) | Pts (313) | Attitudes about diabetes treatment, data recording, use of mobile applications | Questionnaire |
| Danne et al 20 ; Germany | Randomized, open-label, parallel-group, multicenter (24 weeks) | HumaPen Memoir vs HumaPen Luxura | T1DM (100) | Pts (257) | Change from baseline in HbA1c, a hypoglycemia, pen acceptance | Blood samples, interviews, questionnaire |
| Gomez-Peralta et al 15 ; Spain | Main functionalities and performance test (NR) | Humalog KwikPen with Insulclock b | T1DM (100) | Pts with diabetes (9-49) | Insulin type detection, dose detection, injection duration, temperature sensing | Insulclock measuring tools and database |
| Guo et al 21 ; China, Germany, UK | Randomized, open-label, crossover, multicenter (90 minutes) | Two pens without memory function (Humapen Luxura & ClikSTAR) vs two pens with memory function (NovoPen 5 & Humapen Memoir) | T1DM (26) T2DM (74) | Pts (278) HCPs (102) | Pt/HCP preference a and usability | Face-to-face interview, questionnaire |
| Klausmann et al 23 ; Canada, China, Germany | Randomized, crossover, multicenter study (60 minutes) | NovoPen 5 vs HumaPen Luxura | T1DM (25) T2DM (75) | Pts (300) HCPs (150) | Pt and HCP preference a and usability | Face-to-face interview, questionnaire |
| Olsen et al 24 ; Canada, France, Germany | Randomized, open-label, crossover, multinational, multicenter (45-90 minutes) | NovoPen Echo vs NovoPen Junior and HumaPen Luxura | T1DM (100) | Pediatric pts (79) Parents (78) HCPs (48) | Pediatric pts, parents, and HCP preference and usability | Face-to-face interview, rating scales |
| Venekamp et al 25 ; 21 countries in Europe, India, South Africa | Multicenter, single-arm, open-label, observational study (6-10 weeks) | HumaPen Memoir vs pre-study delivery system for glargine (if used) | T1DM (38) T2DM (62) | Pts (304) | Pen functionality, a glycemic control, pt preference, acceptance, and confidence in delivery system, HCP acceptance | Laboratory procedures, pt questionnaire, pt diary |
a
Stated primary endpoint.
b
Connected smart cap for insulin pens.
Abbreviations: HbA1c, glycosylated hemoglobin; HCPs, healthcare providers; NA, not applicable; NR, not reported; pt(s) patient(s); T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus; UK, United Kingdom.