Søren Kruse Lilleøre

Novopen Echo® for the delivery of insulin: a comparison of usability, functionality and preference among pediatric subjects, their parents, and health care professionals.

Background: Despite advances in insulin pen design and functionality, the selection of pens available for children with diabetes is limited. This study assessed the usability, functionality and attitudes towards NovoPen Echo®, a new durable insulin pen designed for pediatric patients that combines a simple memory function with half-increment dosing, versus NovoPen® Junior and HumaPen® Luxura® HD in pediatric subjects, their parents, and health care professionals (HCPs). Methods: Pens were evaluated in random order during 1:1 interviews in the three target groups (pediatric subjects, parents, and HCPs) in Germany, France, and Canada. Study participants were asked to prepare each pen, perform injections into foam cushions, and provide feedback via a standardized questionnaire. Results: In total, 205 participants were included in the study. On a scale of 1–6 (1 = most favorable; 6 = least favorable regarding overall appearance, shape, colors, thickness and length), NovoPen Echo received the most favorable rating for design and overall appearance (mean ± standard deviation = 1.71 ± 0.79) compared with NovoPen Junior (2.02 ± 0.93) and HumaPen Luxura HD (2.36 ± 1.01). Furthermore, 89% of pediatric subjects and 94% of parents rated the memory function of NovoPen Echo as very easy/easy to use. When asked to rate the pens overall, 80% of participants preferred NovoPen Echo to the other pens (p < 0.0001). Conclusions: The results demonstrate a high overall level of satisfaction with NovoPen Echo among pediatric subjects, parents, and HCPs. The novel design aspects of NovoPen Echo, namely t1468-he simple memory function, half-increment units and, ease of use and design, may contribute towards promoting treatment adherence, which is essential in the pediatric setting.

Increased nocturnal fat oxidation in young healthy men with low birth weight: Results from 24-h whole-body respiratory chamber measurements

OBJECTIVE Low birth weight (LBW), a marker of disturbed fetal growth, is associated with adiposity and increased risk of type 2 diabetes (T2D). The aim of the study was to investigate whether LBW is associated with changes in 24-h energy expenditure (EE) and/or substrate utilization rates, potentially contributing to the development of adiposity and/or T2D compared to matched control subjects. MATERIALS/METHODS Forty-six young, healthy men were included in the study; 20 with LBW (≤ 10th percentile) and 26 control subjects with normal birth weight (NBW) (50th-90th percentile). The subjects were fed a weight maintenance diet and 24-h energy expenditure (EE), respiratory quotient (RQ), and substrate oxidation were assessed in a respiratory chamber. RESULTS No differences in 24-h EE, RQ or substrate oxidation were observed between LBW and controls. Interestingly, the LBW group exhibited lower nocturnal RQ compared to controls (0.81 ± 0.01 vs. 0.85 ± 0.01 (mean ± SE), P = 0.01), and hence higher nocturnal fat oxidation (2.55 ± 0.13 vs. 2.09 ± 0.12 kJ/min (mean ± SE), P = 0.02). CONCLUSIONS Young LBW men do not exhibit reductions in 24-h EE. However, LBW subjects display increased nocturnal fat oxidation at the expense of reduced glucose oxidation. We speculate that this may be associated with insufficient capability to retain fat in subcutaneous adipose tissue after meals during day time, with an increased rate of nocturnal and morning lipolysis, and potentially with subtle elevations of gluconeogenesis and of fasting glucose levels in the LBW subjects.

Needle with a Novel Attachment Versus Conventional Screw-Thread Needles: A Preference and Usability Test Among Adults with Diabetes and Impaired Manual Dexterity

BACKGROUND NovoTwist(®) (Novo Nordisk A/S, Bagsværd, Denmark) is an insulin pen needle that features a novel attachment and detachment system. The aim of this test was to assess overall preference and handling of NovoTwist compared with conventional screw-thread needles in people with type 1 or type 2 diabetes. METHODS One hundred twenty adults with type 1 or type 2 diabetes and manual dexterity dysfunction who were currently self-injecting with an insulin pen were included in this open-label, randomized, crossover test. Participants were stratified according to the impact that manual dexterity problems had on their ability to inject insulin (1 = no effect at all; 4 = a lot), and those rated as 1 were excluded from subanalyses because of low numbers. Following instruction, participants attached the needle to Next Generation FlexPen(®) (Novo Nordisk A/S), made an injection into a foam cushion, and detached the needle; this process was repeated three times with NovoTwist and the participants current screw-thread needle (or NovoFine(®) [Novo Nordisk A/S]) in a random order. Responses to questions on user experience with each needle were subsequently recorded on a 6-point rating scale (1 = very difficult; 6 = very easy). RESULTS Significantly more respondents had a preference for NovoTwist (79%) compared with the conventional screw-thread needles (21%, P < 0.001). Significantly more respondents preferred NovoTwist for both ease of attachment (80%, P < 0.001) and ease of detachment (74%, P < 0.001). Most respondents found NovoTwist the most appropriate needle for performing everyday injections (71%, P < 0.001). CONCLUSIONS Such preference by patients has a positive impact on the treatment of diabetes as NovoTwist may alleviate the burden of performing everyday injections through its ease of use.

Dose accuracy and durability of a durable insulin pen before and after simulated lifetime use

Abstract Background and objective: NovoPen Echo is an insulin pen designed specifically for children and adolescents with diabetes. The pen combines half-unit dosing and a simple memory function that records the size of the last dose and the time in hours that has elapsed since last injection. Durability is an essential feature of durable insulin pens in order to ensure accuracy throughout the lifetime of the pen. This study was designed to assess dose accuracy and durability of NovoPen Echo before and after simulated lifetime use. *NovoPen Echo is a registered trademark of Novo Nordisk A/S, Bagsvaerd, Denmark. Research design and methods: All testing was conducted according to International Organization for Standardization (ISO) guideline 11608-1 for pen injectors. Dose accuracy was measured for the delivery of 0.5 international units (IU) (5 mg), 15 IU (150 mg) and 30 IU (300 mg) test medium before and after lifetime simulation under standard, cool and hot conditions. Functionality tests were also performed under a number of stress conditions including dry heat, cyclical temperature, vibration, free fall and electrostatic discharge. **1IU for human insulin corresponds to 1U for modern insulin. Results: The dose accuracy of NovoPen Echo meets the requirement stated in ISO 11608-1 for all three doses for all tests before and after lifetime simulation. The pens remained intact and retained dosing accuracy at all doses after exposure to variations in temperature and humidity and before and after physical challenge to simulate lifetime use. Conclusions: The accuracy of NovoPen Echo was retained under conditions of stress likely to be encountered in everyday use due to its durable design.

Perceptions of Barriers to Effective Obesity Care: Results from the National ACTION Study

ACTION (Awareness, Care, and Treatment in Obesity maNagement) examined obesity‐related perceptions, attitudes, and behaviors among people with obesity (PwO), health care providers (HCPs), and employer representatives (ERs).

Compatibility testing of two types of pen needles with a range of injection pens for diabetes medication

Abstract Compatibility of two types of needles with a variety of durable and prefilled injection pens for diabetes medication was tested by attaching the needles according to ISO 11608-2 and verifying penetration into the cartridge using air shots and two-dimensional X-rays. NovoFine* and NovoFine Autocover† attached correctly to 20 and 19 out of 21 pen types, respectively. Neither needle type attached to Diapen 3.1/3.2, while NovoFine Autocover attached to most, but not all of OptiSet pens.

Needle with a Novel Attachment versus Conventional Screw-Thread Needles: A Preference and Ease-of-Use Test among Children and Adolescents with Diabetes

Background: This usability test investigated the overall preference and usability of the novel NovoTwist® insulin pen needle versus conventional screw-thread needles, when used with Next Generation FlexPen®, in children and adolescents with diabetes. Methods: This was an open-label, randomized, crossover usability test in children and adolescents with type 1 diabetes who administered insulin with an insulin pen. Test needles were NovoTwist and the participants current screw-thread needle (or NovoFine® needle). Following instruction, participants attached the needle to Next Generation FlexPen, made an injection into a foam cushion, and detached the needle. This procedure was conducted three times with both needles in a random order. Responses to 13 questions on user experience with each needle (including overall preference, ease of attachment/detachment of needle/cap, handling, learning, confidence in attachment, and convenience of use) were subsequently recorded on a six-point rating scale (1 = very difficult; 6 = very easy). Results: Fifteen children aged ≥6 to ≤12 years and 15 adolescents aged ≥13 to ≤17 years participated in the test. A significantly higher proportion of children and adolescents (77%) indicated that they would prefer to use NovoTwist compared with screw-thread needles (p = .005). NovoTwist was preferred by most children and adolescents for overall ease of use (77%; p = .005), for ease of attachment (87%; p < .001) and detachment (83%; p < .001), and as the most appropriate needle to handle for daily injections (73%; p = .016). The mean rating for confidence in correct needle attachment was not significantly different between the two needle types. Seven out of eight parents of children who required assistance for their daily insulin injections stated that they would be “very likely” to allow their child to attach NovoTwist. Conclusions: These factors may promote confidence in this needle, and thus in self-injecting, among younger patients and their parents.