Children and adolescent acceptability of a new device system to administer human growth hormone--a pilot study.

BACKGROUND: Growth hormone (GH) is used to treat growth failure in children and metabolic impairments in adults with GH deficiency (GHD). Treatment requires daily subcutaneous injections that may affect treatment outcomes, and subsequently efficacy outcomes. To enhance potential adherence, improved GH delivery device systems are being developed. OBJECTIVE: To compare patient acceptability and usability of Norditropin FlexPro/FlexPro PenMate with Norditropin NordiFlex/NordiFlex PenMate for GH administration in children/adolescents with GHD. METHODS: A multinational, open-label, uncontrolled study. Patients (n = 50; 4-18 years) currently on GH therapy injected test medium into a foam pad. Ease-of-use and patient device preference were recorded by questionnaire. RESULTS: The majority (80%) of patients preferred FlexPro PenMate over NordiFlex PenMate with 96% and 84%, respectively, reporting that they found the FlexPro PenMate system user-friendly and that they were highly confident using it. CONCLUSION: The FlexPro system was well accepted by patients. This may facilitate greater adherence to treatment and improve patient outcomes.

Patient preference for a new growth hormone injection device: results of an open-label study in Japanese pediatric patients.

BACKGROUND: Growth hormone deficiency (GHD) in children is treated with daily subcutaneous injections of GH. Poor adherence, resulting in suboptimal treatment outcomes, is common due to long-term treatment. Injection devices that are considered easy to use by patients or guardians could improve adherence. OBJECTIVE: This study assessed the usability of the Norditropin FlexPro pen injector and NovoTwist needles (both Novo Nordisk A/S, Bagsvaerd, Denmark) in Japanese children and adolescents with GHD. METHODS: This open-label, uncontrolled usability test included patients aged 6 to < or = 18 years with GHD currently receiving daily injections of GH with pen injectors. Patients performed repeated injections of test medium into a foam cushion. Patients or guardians completed a questionnaire on pen handling. RESULTS: A total of 73/74 patients (99%) rated Norditropin FlexPro easy to handle, reporting no technical complaints. In total, 60 (81%) preferred Norditropin FlexPro over their current device, with 12% preferring their current device and 7% not sure. CONCLUSIONS: Norditropin FlexPro was perceived as easy to use and reliable, and was well accepted and preferred over the current device for the administration of GH in children and adolescents. Patients were more confident that Norditropin FlexPro delivered the right dose compared with their current device.

User Satisfaction and Insulin Pump Handling With a Prefilled Insulin Cartridge in Adults and Adolescents With Type 1 Diabetes.

BACKGROUND: This comparative handling study investigated user satisfaction and insulin pump handling with a prefilled insulin cartridge versus a self-filled insulin reservoir in insulin pump users with type 1 diabetes (T1D). METHODS: Adult (n = 105) and adolescent (n = 25) participants performed insulin pump preparations using a prefilled insulin cartridge and self-filled insulin reservoir. User satisfaction, insulin pump preparation time, and residual air in infusion set tubing were assessed for each insulin filling method. Post hoc analysis evaluated training time. RESULTS: User satisfaction scores were statistically significantly different in favor of the prefilled insulin cartridge versus the self-filled insulin reservoir (mean [SD]: overall, 4.0 [0.5] vs 3.3 [0.9]; burden on the user, 1.8 [0.6] vs 2.9 [1.0]; user inconvenience, 2.0 [0.7] vs 2.8 [1.1]; device effectiveness, 3.9 [0.7] vs 3.6 [0.9]; all P < .001). Insulin pump preparation time and residual air measurements were significantly different and numerically lower for the prefilled insulin cartridge versus the self-filled insulin reservoir (mean [SD]: preparation time, 124.4 [30.3] vs 237.8 [64.2] seconds, P < .001; residual air, 2.3 [26.3] vs 10.0 [63.3] mm, P = .007). Training time was shorter with the prefilled insulin cartridge versus the self-filled insulin reservoir (mean [min; max]: 193.1 [36; 453] vs 535.8 [124; 992] seconds). CONCLUSIONS: Adult and adolescent insulin pump users were more satisfied with the prefilled insulin cartridge versus the self-filled insulin reservoir when preparing an insulin pump. The prefilled insulin cartridge was associated with reduced insulin pump preparation time and reduced training time versus the self-filled insulin reservoir.

Intuitiveness, ease of use, and preference of a prefilled growth hormone injection pen: a noninterventional, randomized, open-label, crossover, comparative usability study of three delivery devices in growth hormone-treated pediatric patients.

BACKGROUND: Growth hormone (GH) is used to treat pediatric and adult GH deficiency (GHD) and growth failure in, among others, patients with Turner syndrome or children born small for gestational age. To improve treatment adherence, self-injection devices should be easy to learn, easy to use, and well accepted, especially in pediatric patients. Several GH pen devices are available, each with distinct features designed for specific patient needs. OBJECTIVES: This study compared injection time and intuitiveness of a prefilled test injection device (Norditropin FlexPro, Novo Nordisk A/S, Bagsværd, Denmark) with those of 2 commercially available durable injection devices (easypod, Merck Serono SA, Geneva, Switzerland; and Genotropin, Pfizer Inc, New York, New York) in GH-treated pediatric patients. Dose accuracy, application errors, intuitiveness, usability, device features, ease of learning, ease of use, and overall preference were also assessed. METHODS: This noninterventional, randomized, open-label, crossover study enrolled patients aged ≥10 to <18 years who were diagnosed with GHD or Turner syndrome or were born small for gestational age. Patients were allocated to an intuitiveness group (without instruction) or an instruction group and assigned to 1 of 3 sequences of device testing. For each device, time taken to deliver a mock injection of test medium (FlexPro) or GH (easypod and Genotropin) into an Eppendorf tube and the delivered dose were measured. Dose accuracy and application errors were assessed by a health care professional. Patients assessed the intuitiveness (intuitiveness group only), device features, ease of learning, ease of use, and overall preference of the devices using questionnaires. RESULTS: Included in the study were 56 patients (mean [SD] age, 13.6 [2.1] years; 63% male; GHD, 44 patients; Turner syndrome, 3; born small for gestational age, 9): 30 in the intuitiveness group and 26 in the instruction group. In the intuitiveness group, the mean (SD) mock injection time was significantly shorter with FlexPro (47.0 [49.0] seconds) than with the easypod (219.2 [72.6] seconds; P < 0.001) or the Genotropin pen (95.1 [78.4] seconds; P < 0.01). In the instruction group, injection time was also shortest with FlexPro (30.7 [10.8] seconds vs 59.6 [13.1] with easypod and 40.7 [18.6] with the Genotropin pen; both, P < 0.001). Most patients (70%) ranked FlexPro as the most intuitive device (easypod, 0%; Genotropin, 30%). In both the intuitiveness and instruction groups, a significantly greater proportion of patients considered FlexPro easiest to learn compared with the easypod and Genotropin devices (both, P < 0.001), although more patients preferred the easypod or Genotropin devices than FlexPro with regard to appearance (intuitiveness group: FlexPro, 8 patients; easypod, 9; and Genotropin, 13; instruction group: FlexPro, 4; easypod, 10; and Genotropin, 12) and quality (intuitiveness group: FlexPro, 6 patients; easypod, 10; and Genotropin, 14; instruction group: FlexPro, 8; easypod, 12; and Genotropin, 6), and easy- pod's delivery feedback feature was preferred by more patients (intuitiveness group: FlexPro, 8 patients; easypod, 14; Genotropin, 8; instruction group: FlexPro, 8; easypod, 14; and Genotropin, 4). Dose accuracies (as assessed by weighing the delivered dose and calculating variation in the delivered dose by device) were 4.6% with FlexPro, 14.6% with easypod, and 20.6% with the Genotropin pen in the intuitiveness group, and 2.7% with FlexPro, 5.8% with easypod, and 24.4% with the Genotropin pen in the instruction group. CONCLUSION: In this study, Norditropin FlexPro was associated with shorter injection times, higher dose accuracy, and greater intuitiveness, and was rated as easier to learn compared with the easypod and Genotropin devices.

Ease of use and acceptability of a new pen device for the administration of growth hormone therapy in pediatric patients: an open-label, uncontrolled usability test.

BACKGROUND: Recombinant human growth hormone (GH) is used for the treatment of several conditions associated with growth retardation and metabolic dysfunction. These patients are typically diagnosed and treated from childhood, and treatment adherence in children might be problematic. To potentially improve treatment adherence in children who self-inject GH, it is important that devices for the administration of GH are simple to learn to use, simple to use, and well accepted by patients and their parents or guardians. OBJECTIVE: This study compared the usability and acceptability of the Norditropin FlexPro pen and NovoFine needles (Novo Nordisk A/S, Bagsvaerd, Denmark) for the administration of GH in pediatric patients with GH deficiency (GHD). METHODS: Patients aged 10 to <18 years with GHD and who were receiving daily treatment with selfinjectable GH were included in this open-label, uncontrolled usability test. Patients used the Norditropin FlexPro pen and NovoFine G32 needles to inject test medium into an injection pad; this test was repeated. For the assessment of patients' acceptance of the device, patients completed a 21-item questionnaire regarding pen performance before and during injection. RESULTS: Seventy patients participated in the study (mean age, 14 years; 67% male; 23% left-handed). No significant differences in demographic characteristics (age, sex, duration of treatment with GH, current device used, and left- or right-handedness) were found between boys and girls, younger and older children, or children who had been receiving short-term (months) or long-term (years) GH treatment. Sixty-eight patients (97%) rated attachment of the needle, priming the device, dialing up the dose, and reading the scale on the device as very easy or quite easy. A total of 99% of patients rated injection of their usual dose and of a 4-mg dose as very easy or quite easy, and pushing the dose button as very easy or quite easy as well as very comfortable or quite comfortable. All of the patients rated hearing the click while performing the injection as very easy or easy. Overall, 64% of patients indicated a preference for the Norditropin FlexPro pen over the device they were currently using. CONCLUSIONS: In this preliminary usability test in pediatric patients, the Norditropin FlexPro pen was perceived as reliable and easy to use and was well accepted. There was also a high level of comfort that GH had been injected properly and that the correct dose had been delivered among the children and adolescents with GHD who participated in the study.