Marcus Niemeyer

Usability and preference evaluation of a prefilled insulin pen with a novel injection mechanism by people with diabetes and healthcare professionals

Abstract Objective: This cross-over usability study assessed the perceptions of, and preference for, FT (FlexTouch), a new prefilled insulin pen, compared with KP (KwikPen) another widely available prefilled insulin pen, among people with diabetes and healthcare professionals (physicians and nurses). *FlexTouch (FT) is a registered trade name of Novo Nordisk A/S, Bagsvaerd, Denmark. †KwikPen (KP) is a registered trade name of Eli Lilly & Co., Indianapolis, IN, USA. Research design and methods: Participants were randomly assigned to start with either FT or KP. Following instruction on how to operate the pen, the participant performed several injections at different doses into a foam cushion and then answered written questions on ease of use, confidence and preference. Results: Seventy-nine people with diabetes and 81 healthcare professionals (40 physicians and 41 nurses) took part. Overall, most respondents preferred using FT (86%) to KP (7%; p < 0.001), found FT (85%) the easier pen to use versus KP (4%; p < 0.001), and would recommend FT (88%) rather than KP (6%; p < 0.001). Ratings for FT were also significantly higher than for KP on questions relating to the injection process, including ease of depressing the push-button and ease of injecting at three dose levels (20 International Units [IU], 40 IU and 60 IU [p < 0.001 for all]). Significantly more respondents chose FT as the pen that gave them most confidence in correct and complete insulin delivery (73% vs. 6% for KP; p < 0.001). Conclusions: FT was rated significantly higher (all p < 0.001) for ease of use and confidence, and was preferred over KP by people with diabetes, physicians and nurses. The features of FT may improve the insulin injection experience for a wide range of users. A limitation of the usability questionnaire employed in this study is that it did not assess the factors that influence preference. Additional analyses could be conducted using multivariate regression to help elucidate the features of FT that appeal to different users.

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.

Accuracy and preference assessment of prefilled insulin pen versus vial and syringe with diabetes patients, caregivers, and healthcare professionals

Abstract Objectives: The primary objective of this study was to investigate the dosing accuracy of the new prefilled FlexTouch insulin pen (FT) in comparison to conventional vial and syringe (V&S) when used by patients (Pts), caregivers (CG) and healthcare professionals (HCPs). Methods: A total of 120 subjects participated in the trial (40 diabetes patients aged 61 ± 11 [mean ± SD] yrs, 20 caregivers [parents and other relatives], 20 physicians, and 40 nurses/certified diabetes educators). The participants were introduced to the devices in randomized order and were asked to perform injections of 5, 25, 43 and 79 IU doses into laboratory tubes. Dosing accuracy was analyzed by weighing the tubes on a pharmaceutical balance and calculating the mean absolute deviation (MAD) from the intended doses. After completing a device assessment questionnaire, Patient Perception Questionnaire (PPQ), with questions regarding device design and performance, the procedure was repeated for the other device, and the patients were finally asked to complete a device preference questionnaire (DPQ). Results: Dosing accuracy was significantly better for FT when used by any of the cohorts at all doses. (MAD ± SD for FT/V&S; 5 IU: 0.4 ± 0.4/0.6 ± 0.6 IU; 25 IU: 0.3 ± 0.4/0.7 ± 0.9 IU; 43 IU: 0.4 ± 0.4/0.9 ± 1.2 IU; 79 IU: 0.5 ± 0.5/1.7 ± 1.6 IU, p < 0.005 for all doses). Dosing accuracy with FT for all three subgroups was comparable (patients: 0.35–0.59 IU; HCP&CG: 0.29–0.54 IU; n.s.). Dosing accuracy with V&S for all three subgroups was not comparable: HCP and CG performed much better with V&S than patients and delivered the doses with significantly higher accuracy (range of mean MAD; patients: 0.81–2.54 IU; HCP&CG: 0.51–1.30 IU, p < 0.005 at all doses). FT was ranked superior to V&S for all aspects of the PPQ. In the DPQ, 93% of the patients voted for FT (neutral: 5%, V&S: 2%), (CG: 100%/0%/0%; HCPs: 85%/2%/13%; p < 0.001 in all cases). Conclusion: FT, compared to V&S, was more accurate at all tested doses and was used with similar accuracy by patients, HCPs, and CGs. Using questionnaires only, and without dexterity assessment, study participants rated FT higher than V&S in every component of the PPQ and the vast majority of them preferred FT. These findings may point to a better alternative for dosing accuracy and improved adherence when using the new prefilled insulin pen compared to V&S for insulin delivery in patients with diabetes.

Healthcare professional and patient assessment of a new prefilled insulin pen versus two widely available prefilled insulin pens for ease of use, teaching and learning

Abstract Objective: FlexTouch (FT) is a new prefilled insulin pen with no push-button extension at any set dose and a low activation force that is designed to improve ease of use and insulin administration. This paper reports the results of two usability studies assessing perceptions of FT compared with KwikPen (KP)and SoloStar (SS) among healthcare professionals (HCPs; both physicians and nurses) and people with diabetes (both insulin pen-experienced and insulin pen-naïve). *FlexTouch is a registered trade name of Novo Nordisk A/S, Bagsvaerd, Denmark. †KwikPen is a registered trade name of Eli Lilly & Co., Indianapolis, IN, USA. ‡SoloStar is a registered trade name of Sanofi, Paris, France. Research design and methods: Participants were randomly assigned to start with FT or KP in one study and FT or SS in the other. Participants performed injections at different doses (20, 40 and 60 International Units [IU] in the FT vs. KP study or 20, 40 and 80 IU in the FT vs. SS study) into a foam cushion before answering questions on ease of use, teaching and learning, confidence and preference. Results: A total of 59 people with diabetes and 61 HCPs took part in the FT vs. SS study, and 79 people with diabetes and 81 HCPs took part in the FT vs. KP study. Considerably more patients and HCPs rated FT as very/fairly easy to inject with than KP or SS, particularly at the maximum dose (≥80% vs. ≤38% and ≤23%, respectively), and more were very/rather confident in the ability to manage daily insulin injections with FT than KP or SS. Overall, FT was rated significantly higher for ease of teaching and learning to use than KP or SS (all p < 0.001 vs. FT), and was preferred for teaching and learning compared with KP or SS (≥39% vs. ≤4% and ≤6%, respectively). More patients and HCPs would recommend FT (≥95%) than KP (≤72%) or SS (≤71%). The same pattern was generally seen across physicians, nurses, insulin pen-experienced and pen-naïve participants. Conclusions: The findings suggest that devices such as FT are easy to use and can be prescribed with relatively few training needs, which may improve ease of insulin initiation, increase pen use, and ultimately improve treatment adherence. A limitation of the usability questionnaire used in this study is that it did not assess the factors that influence preference. Further analyses could be conducted to determine the factors that appeal to different users.

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.

An assessment of dose accuracy and injection force of a novel prefilled insulin pen: comparison with a widely used prefilled insulin pen

Objective: FlexTouch (FT) (Novo Nordisk A/S, Bagsværd, Denmark) is a new prefilled insulin pen with a novel injection mechanism encompassing no push-button extension at any dose-setting. This study assessed the dose accuracy and injection force of FT compared with the established Next Generation FlexPen (NGFP) (Novo Nordisk A/S Bagsværd, Denmark). Research design and methods: Dose accuracy was measured at the minimum, medium and maximum doses (FT, 1, 40 and 80 international units (IU) and NGFP, 1, 30 and 60 IU). Injection force was measured during the injection of the maximum dose (FT, 80 IU; NGFP, 60 IU). Main outcomes: FT and NGFP delivered insulin accurately and consistently at all doses (mean ± s.d., FT at 1 IU, 0.98 ± 0.07; 40 IU, 39.86 ± 0.33; 80 IU, 79.76 ± 0.64; NGFP at 1 IU, 1.02 ± 0.08; 30 IU, 29.69 ± 0.30; 60 IU, 59.50 ± 0.51). FT had a significantly (p < 0.0001) lower injection force than NGFP. Conclusions: The study demonstrated that FT and NGFP deliver insulin accurately and consistently at low, medium and high doses. The novel torque spring injection mechanism of FT results in a significantly lower injection force than NGFP and a pen requiring less thumb-pressure to inject insulin may be welcomed by many people with diabetes.

Self-assessment and objective determination of dexterity in patients with type 1 or type 2 diabetes mellitus

Abstract Objective: Insulin-treated patients perform complex treatment activities during daily routine, such as blood glucose measurements and insulin injections. We aimed to identify suitable dexterity and cognitive function tests for diabetes patients, and to compare the patient self-assessment of their dexterity skills with the test results (Jebsen–Taylor hand function test, (JHFT), motoric performance test (MLS), number connection test). Method: We enrolled 90 diabetes patients (36 females, 54 males): 15 type 1 with clinically suspected dexterity impairment (A: age: 60 ± 9 years), 30 type 2 with clinically suspected dexterity impairment (B: 61 ± 10 years), 30 type 1 or type 2 patients with visual impairment (C: 64 ± 6 years), and 15 type 1 or type 2 patients without obvious impairment (control group: D: 64 ± 5 years). Results: There were no differences regarding neuropathy and slight impairments in the number connection test in all groups. Patient self-assessment revealed that 33.4% in group A, 33.3% in group B, 36.7% in group C and 13.7% in group D, considered themselves to have dexterity impairment. However in the JHFT test, all patients from A (100%) and B (100%), 33% from C, and 0% from D presented with dexterity impairment by only passing less than four subtests. Conclusions: Impairment of dexterity was much more frequent than believed by the patients themselves. It may be worthwhile to consider these findings when classifying patients regarding their capabilities to perform certain treatments or when assessing diabetes technology with human subjects.

FlexTouch: A Prefilled Insulin Pen with a Novel Injection Mechanism with Consistent High Accuracy at Low- (1 U), Medium- (40 U), and High- (80 U) Dose Settings

Background: FlexTouch® is the only prefilled insulin pen that utilizes an easy touch button that does not extend at any dose in place of a push-button extension. Rigorous testing has shown that the new FlexTouch pen accurately and consistently delivers insulin doses. Methods: This study assessed dose accuracy of FlexTouch, KwikPen®, and SoloSTAR®. Dose accuracy for minimum, medium, and maximum doses of each pen type (1, 40, and 80 U for FlexTouch and SoloSTAR and 1, 30, and 60 U for KwikPen) was assessed. Results: FlexTouch delivered all doses consistently, as demonstrated by low standard deviations. FlexTouch showed similar accuracy to KwikPen at 1 U and to SoloSTAR at 40 and 80 U. However, FlexTouch was significantly more accurate at delivering 1 U of insulin than SoloSTAR (p < .0001). Conclusions: This study demonstrates that FlexTouch, a new prefilled pen, delivers insulin accurately and consistently at low, medium, and high doses. In addition, FlexTouch is currently the only prefilled pen that has a push button that does not extend at any dose, making FlexTouch easier to use than other pens.

Injection force and dose accuracy of FlexTouch for the delivery of a new basal insulin.

Objective: The aim of the paper is to determine the dose accuracy and injection force of FlexTouch (FT) filled with insulin degludec 100 U/ml, insulin degludec 200 U/ml and insulin degludec/insulin aspart 100 U/ml, SoloStar (SS) filled with insulin glargine 100 U/ml and KwikPen (KP) filled with insulin lispro mix 75/25 100 U/ml. Methods: Dose accuracy was measured at minimum, midpoint and maximum doses (FT 1, 2, 40, 80 and 160 U; SS 1, 40 and 80 U; KP 1, 30 and 60 U). Injection force was measured during the injection of the maximum dose. Results: All doses delivered from FT were within ISO limits (ISO 11608-1:2012) for degludec 100 U/ml, degludec 200 U/ml and degludec/aspart 100 U/ml, and the pens delivered insulin accurately and consistently at all doses tested. Similarly, all tested doses from KP filled with insulin lispro mix 75/25 100 U/ml were within ISO limits, while some doses from SS filled with insulin glargine 100 U/ml were outside ISO limits. FT had a significantly lower injection force than SS and KP (p < 0.05). Conclusions: FT filled with insulin degludec and insulin degludec/insulin aspart, delivered insulin accurately and consistently within ISO limitations at all doses tested; similarly, KP delivered insulin within ISO limitations at all doses tested and SS delivered most doses within ISO limitations. The significantly lower injection force of FT compared to SS and KP is an important feature that has the potential to make the injection process easier for people with diabetes.

Assessment for ease of use and preference of a new prefilled insulin pen (FlexTouch Degludec U100/U200) versus the SoloSTAR insulin pen by patients with diabetes and healthcare professionals

Objective: FlexTouch® (FT) is a new prefilled insulin pen with no push-button extension and a low injection force used to deliver several basal insulins, including insulin degludec across a wide dose range (1 – 80 units with FT 100 IU/ml [FT100] and 2 – 160 units with 200 IU/ml [FT200]). This study was carried out to evaluate whether the novel features of FT affect the preferences of the device among patients with diabetes and healthcare professionals compared with the widely used SoloSTAR® pen. Research design and methods: A multicenter, randomized, open-label, crossover study compared FT100 and FT200 with SoloSTAR. The study included patients with either type 1 (n = 22) or type 2 diabetes (n = 42), nurses (n = 32) and physicians (n = 32). Subjects were randomized to test each of the FT100, FT200 and SoloSTAR pens in a crossover set up. Subjects performed injections into a foam cushion at 4 – 6 different doses per device (2, 20, 40, 80, 120 and 160 IU). Results: Overall, a significantly higher proportion of subjects, including dexterity-impaired and pen-naive patients, preferred to use FT100 (93.0%; 119/128) and FT200 (91.4%; 117/128) compared with 2.3% (3/128) and 3.9% (5/128) who preferred SoloSTAR (p < 0.001), respectively. Conclusion: FT100 and FT200 were preferred over SoloSTAR by nurses, physicians and patients with diabetes. This may be due to the novel design of FT, which improves ease of use, preference and confidence in delivering a complete, accurate dose of insulin, even at high doses.