Semaglutide single-dose pen-injector: Post hoc analysis of summative usability testing for weight management.

Subcutaneous semaglutide, at a 2.4 mg once-weekly maintenance dose, is approved in the United States for weight management in individuals with a body mass index (BMI) of 30 kg/m2 or higher, or with a BMI of 27 kg/m2 or higher and at least one obesity-related co-morbidity. To investigate the usability of the semaglutide pen-injector in individuals who met these criteria, we report post hoc analysis of the summative (human factors validation) usability testing and safety analysis involving patients with type 2 diabetes (an obesity-related co-morbidity) with the same pen-injector, limited to the 26 out of 30 patients with a BMI of 27 kg/m2 or higher (11 pen-injector-naïve, 15 pen-injector-experienced) and 15 non-pharmacist healthcare professionals (HCPs). Participants performed two simulated injections into an injection pad. No potentially serious use errors occurred. Mean subjective ease-of-use rating on a seven-point scale, where 1 = difficult and 7 = easy, was 6.9 for the second injection in all three groups. These results suggest that the semaglutide pen-injector is easy to use and not associated with serious use errors when used by pen-injector-naïve or pen-injector-experienced patients meeting the requirement for weight management with semaglutide treatment, and by non-pharmacist HCPs.

Injecting without pressing a button: An exploratory study of a shield-triggered injection mechanism.

AIMS: To evaluate the injection success and user perception of a shield-triggered pen-injector mechanism. METHODS: The trial (ClinicalTrials.gov NCT02627287) was an exploratory, two-centre, one-visit, open-label, randomized controlled trial conducted in Germany in 150 injection-experienced individuals with type 1 or type 2 diabetes. Participants self-administered subcutaneous injections of a placebo solution using a prototype shield-triggered pen-injector, DV3316 (Novo Nordisk, Bagsvaerd, Denmark), and FlexPen (Novo Nordisk, Bagsvaerd, Denmark). Injection success was evaluated on a yes/no basis by the investigator. Participant confidence, leakage of fluid and pain were evaluated after each injection. Pain and device experience were assessed after completion of all injections with each pen-injector. Overall preference was assessed after completion of all injections with both pen-injectors. RESULTS: Injection success was high with both pen-injectors (97.0%, DV3316 vs 99.7%, FlexPen). Participant confidence in dose delivery was similar for the two devices (88% of injections with DV3316 vs 81% with FlexPen were scored as "extremely confident"). The median injection pain score on a visual analogue scale (0-100) was 3 with DV3316 vs 4 with FlexPen after each injection, and 4 with DV3316 vs 5 with FlexPen after all injections with each device. After all injections were completed, 55% of participants reported an overall preference for DV3316 vs 21% for FlexPen. CONCLUSION: This study demonstrates that injection-experienced individuals can achieve a high injection success rate with a shield-triggered pen-injector, with similar patient confidence and injection pain compared with FlexPen.

Evaluating the usability and safety of the semaglutide single-dose pen-injectors through summative (human factors) usability testing.

AIMS/INTRODUCTION: A single-dose, shield-activated pen-injector for each of the three approved dose variants (0.25, 0.5 and 1 mg) of once-weekly subcutaneous semaglutide has been developed to improve usability. This analysis presents findings from the summative usability testing process for the single-dose semaglutide pen-injectors, including the pen-injector four-pack cartons and instructions for use. MATERIALS AND METHODS: A total of 60 adults representing four user groups were included: patients with/without pen-injector experience, non-pharmacist healthcare professionals and pharmacists (each n = 15). Participants carried out four tasks: (i) pen-injector carton retrieval; (ii) first simulated injection; (iii) pen-injector retrieval; and (iv) second simulated injection. All participants carried out task 1, and patients and non-pharmacist healthcare professionals took part in tasks 2-4 (n = 45). The number and types of use errors, close calls and operational difficulties were evaluated, and participants subjectively rated the ease of each task on a scale of 1 (difficult) to 7 (easy). RESULTS: No potentially serious use errors and only one non-serious use error were reported. Eight participants committed use errors with no potential for harm, one participant committed an unclassified use error, one participant encountered a close call with no potential for harm and one participant experienced an operational difficulty. Mean ease-of-use ratings were 6.7 (task 1), 5.9 (task 2), 6.6 (task 3) and 6.9 (task 4). CONCLUSIONS: All three dose variants of the semaglutide single-dose pen-injector were considered easy to use (subjective feedback scores near 7) and not associated with any serious use errors, even when participants received no training before study participation.

Comparison of intuitiveness, ease of use and preference among three prefilled, disposable growth hormone injection pens.

BACKGROUND: Growth hormone (GH) therapy is an effective treatment for growth failure in children. Adherence rates are often low, resulting in poor linear growth. Intuitive and easy-to-use injection devices may improve adherence. OBJECTIVES: To determine injection time, ease of use, intuitiveness and subjects' preference for Norditropin FlexPro (FP) pen (Novo Nordisk A/S, Denmark) versus Genotropin GoQuick (GQ; Pfizer Inc., USA) and Norditropin NordiFlex (NF; Novo Nordisk) pens. METHODS: Subjects aged ≥ 10 to < 18 years, with GH deficiency, Turner syndrome or short stature following small-for-gestational-age birth were randomized to intuitiveness (no instruction) or instruction groups. Time taken to perform an injection, dose accuracy and errors were recorded. Intuitiveness, ease-of-learning and overall preference were assessed using questionnaires. RESULTS: Sixty-four subjects, randomized to intuitiveness (n = 32; mean [SD] age, 13.1 [2.1] years) and instruction (n = 32; 13.4 [2.0] years) groups, required less time to perform the injection with FP than with GQ (mean [SD], intuitiveness 39.8 s [17.0] vs. 65.6 s [42.9], p < 0.01; instruction 40.7 s [19.7] vs. 48.1 s [25.8], p < 0.05), and a similar amount of time with NF. NF and FP were more accurate than GQ (intuitiveness group only). Fewer errors were recorded with NF followed by FP and GQ. FP and NF were considered easier to learn than GQ in both groups. In the intuitiveness group, the majority of subjects (31/32) felt confident using FP without instruction. FP was the device of overall preference in both groups. CONCLUSION: FP was the device that was most intuitive, easiest to use and the device of overall preference.

Evaluation of preference for a novel durable insulin pen with memory function among patients with diabetes and health care professionals.

BACKGROUND: Improving adherence to insulin treatment for better glycemic control remains a challenge in the management of diabetes. New technological aids are required to help support adherence. This study evaluated preference for the NovoPen(®) 5 (NP5), a durable insulin pen with memory function, compared with the HumaPen Luxura(®) (HPL) among patients with diabetes and health care professionals. METHODS: This crossover, multicenter usability study included insulin pen-experienced patients with diabetes and health care professionals treating patients with diabetes in Canada, China, and Germany. Participants evaluated NP5 and HPL in a randomized order by performing handling tasks in a usability test related to everyday use during a face-to-face interview. Tasks, pens, and preferences were assessed by completing a questionnaire comprised of rating and open-ended questions relating to confidence in everyday diabetes management. RESULTS: Overall, 300 patients with diabetes and 150 health care professionals participated in the study. Significantly more participants preferred NP5 (81%) to HPL (18%) (P < 0.001). Also, 82% of patients with diabetes had more confidence in NP5 for managing their daily injections versus 11% with HPL (P < 0.001), and 7% had no preference. Memory function was most helpful in giving patients with diabetes confidence about when they last injected (63%), how much insulin they last injected (62%) and improving diabetes management (55%). Participants gave higher ratings to NP5 than to HPL on all parameters relating to performing an injection (ease of handling, satisfaction when using the pen, convenience of using the pen day-to-day, quality of the pen, and the extent to which the pen meets their needs; P < 0.05 for all comparisons). CONCLUSION: NP5 was preferred to HPL by most participants. Significantly more patients with diabetes had more confidence for managing daily insulin injections when using NP5, the pen with a memory function.

Evaluation of a new durable insulin pen with memory function among people with diabetes and healthcare professionals.

OBJECTIVES: The aim of the study was to evaluate durable insulin pens among people with diabetes (PwD) and healthcare professionals (HCPs), by comparing two durable insulin pens with memory function: NovoPen® 5 (NP5) and HumaPen® Memoir™ (HPM), and two durable insulin pens without memory function: HumaPen Luxura® (HPL) and ClikSTAR® (CS). RESEARCH DESIGN AND METHODS: This cross-over, multicentre usability test was conducted in China, Germany and the UK. Participants evaluated all four pens in randomised order by performing handling and usability tasks related to everyday use during a face-to-face interview. Tasks, pens and preferences were rated by completing a questionnaire comprising of rating and open-ended questions. RESULTS: NP5 was preferred by 51% of participants compared with HPM (22%, p < 0.01), HPL (12%, p < 0.01) and CS (15%, p < 0.01). Participants preferred the design of NP5 (in particular, appearance, length and robustness). Memory function for the two pens was rated equally by participants, but 54% of PwD rated NP5 as 'very easy' to learn to use versus 22% for HPM and significantly more HCPs found it 'very easy' to teach patients to use NP5 versus HPM (6-point rating scale; difference in mean score, p < 0.01). Substantially, more PwD would be confident in using NP5 (64%) compared with HPM (43%), HPL (49%) and CS (45%) (6-point rating scale; difference in mean score, p < 0.01). CONCLUSIONS: NP5 was preferred by > 50% of PwD and HCPs. NP5 was more highly rated for design, memory function and ease of learning/teaching compared with HPM. Most PwD would be confident in using NP5 for administering daily insulin injections.

Patient device assessment evaluation of two insulin injection devices in a mixed cohort of insulin-treated patients with type 1 or type 2 diabetes mellitus.

OBJECTIVE: FT (FlexTouch*) is a new disposable insulin injection pen device for use in insulin-treated patients with diabetes mellitus. The aim of this study was to evaluate patient perception of FT versus IL (InnoLet†) with respect to the ease of use and patient preference in a mixed patient cohort with different kinds and degrees of visual or dexterity impairments. METHODS: Ninety patients were included into this investigation (54 male/36 female, age [mean ± SD]: 62 ± 8 yrs, disease duration: 18 ± 11 yrs, HbA1c: 7.2 ± 1.0%). After assessment of visual acuity and dexterity skills (by Jebsen-Taylor Hand Function Test), the patients were introduced to the two pen devices in random order, and were asked to perform mock injections with 10 IU, 30 IU and 50 IU doses before completing a 41 item standardized device assessment questionnaire. The questions asked were covering five topics of pen use (confidence in delivering a correct dose, dose setting, performance of the injection, general handling, and others) and could be answered with a rank scale from '1 = very easy' to '5 = very difficult'. RESULTS: FT was ranked superior to IL with respect to the injection procedure (FT: 1.2 ± 0.1 vs. IL: 2.1 ± 0.4, p < 0.001) and general handling (1.3 ± 0.2 vs. 2.3 ± 0.7, p < 0.001), and numerically better with respect to confidence in correct dosing (1.4 ± 0.2 vs. 2.1 ± 0.9, n.s.). The two devices were ranked equally for ease of dose setting (1.6 ± 0.3 vs. 1.7 ± 0.4, n.s.). When ranked individually, FT use was recommended by 92.2% of the patients (IL: 30.0%). KEY LIMITATIONS: Patients of this investigation were from one local area (San Jose, CA, USA) only. The subgroups may be considered small for the performed analysis. CONCLUSIONS: In summary, FT was perceived to be easier to use than IL in this investigation.

Comparison of patient preference for two insulin injection pen devices in relation to patient dexterity skills.

BACKGROUND: Impaired dexterity has been reported to be prevalent in diabetes patients independent from the existence of diabetic neuropathy. This study was performed to investigate the impact of dexterity impairment on patient preference for two insulin pen injection devices (InnoLet and FlexTouch). METHODS: Ninety patients [54 male/36 female; age (mean ± standard deviation), 62 ± 8 years; disease duration, 18 ± 11 years; hemoglobin A1c, 7.2 ± 1.0%] were included in this investigation and were stratified into four different groups based on the results of a dexterity test (Jebsen-Taylor Hand Function Test) and assessment of visual impairment: 15 type 1 (group A) and 30 type 2 (group B) patients with impaired dexterity, 30 type 1/type 2 patients with visual impairment (group C), and 15 type 1/type 2 patients without any impairment (group D). The patients performed a cognitive function test (number connection test), were introduced to the devices in random order, and were asked to perform some mock injections before completing a six-item standardized preference questionnaire. RESULTS: There was a strong preference for FlexTouch in all groups. All unimpaired patients (100%, group D) preferred FlexTouch, as did the vast majority in all other groups. Only 11% of the patients with impaired cognitive function preferred InnoLet, as did a few patients with more severely impaired dexterity or with visual impairment (group A, 13%; group B, 3%; group C, 14%). CONCLUSIONS: Patient dexterity skills may have an influence on device preference, especially if the impairment is more pronounced.

Ease of use and preference of a new versus widely available prefilled insulin pen assessed by people with diabetes, physicians and nurses.

OBJECTIVE: FlexTouch® (FT; Novo Nordisk A/S, Bagsvaerd, Denmark) is a new prefilled insulin pen that has no push-button extension and low injection force. This multi-centre, crossover usability study evaluated the perceptions of, and preference for, FT versus another widely used prefilled pen, SoloStar® (SS; Sanofi, Paris, France), by people with diabetes and healthcare professionals. RESEARCH DESIGN AND METHODS: Following instruction, participants performed injections into a foam cushion, randomly alternating between doses of 20, 40 and 80 international units (IU). Participants then answered questions on usability and preference. RESULTS: In all, 59 people with diabetes and 61 healthcare professionals (30 physicians and 31 nurses) took part. Overall, significantly more respondents preferred to use FT than SS (83 vs 10%, respectively), found FT easier to use (83 vs 9%) and would recommend FT to others (83 vs 8%; p < 0.001 for all). More respondents found it 'very/fairly easy' to reach the push-button and to inject 20, 40 and 80 IU with FT (93, 90 and 88% to inject, respectively) than with SS (73, 43 and 15% to inject, respectively; p < 0.001 for all). Most respondents chose FT as giving them the most confidence in correct and complete insulin delivery (76 vs 6%; p < 0.001) and considerably more were 'very/rather confident' in managing their daily insulin injections with FT than with SS (88 vs 58%). CONCLUSIONS: Most participants rated FT as easier to use and to inject with, were more confident in its accuracy of insulin delivery and preferred it to SS.