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.

Using MALDI-TOF mass spectrometry as a rapid and accurate diagnostic tool in infective endocarditis: a case report of a patient with mitral valve infective endocarditis caused by Abiotrophia defectiva.

A case of infective endocarditis caused by Abiotrophia defectiva is presented. The use of MALDI-TOF mass spectrometry as a rapid and accurate diagnostic tool in infective endocarditis is discussed.

NovoPen Echo(®) insulin delivery device.

The introduction of insulin pen devices has provided easier, well-tolerated, and more convenient treatment regimens for patients with diabetes mellitus. When compared with vial and syringe regimens, insulin pens offer a greater clinical efficacy, improved quality of life, and increased dosing accuracy, particularly at low doses. The portable and discreet nature of pen devices reduces the burden on the patient, facilitates adherence, and subsequently contributes to the improvement in glycemic control. NovoPen Echo(®) is one of the latest members of the NovoPen(®) family that has been specifically designed for the pediatric population and is the first to combine half-unit increment (=0.5 U of insulin) dosing with a simple memory function. The half-unit increment dosing amendments and accurate injection of 0.5 U of insulin are particularly beneficial for children (and insulin-sensitive adults/elders), who often require small insulin doses. The memory function can be used to record the time and amount of the last dose, reducing the fear of double dosing or missing a dose. The memory function also provides parents with extra confidence and security that their child is taking insulin at the correct doses and times. NovoPen Echo is a lightweight, durable insulin delivery pen; it is available in two different colors, which may help to distinguish between different types of insulin, providing more confidence for both users and caregivers. Studies have demonstrated a high level of patient satisfaction, with 80% of users preferring NovoPen Echo to other pediatric insulin pens.

Short-term effects of alcohol-based disinfectant and detergent on skin irritation.

The most important risk factor for occupational contact dermatitis in hospital personnel is the exposure to irritants such as water, detergents and alcohol-based solutions. This study was undertaken to evaluate the short-term effects of repeated exposure to an alcohol-based disinfectant, to a detergent and to an alcohol-based disinfectant/detergent alternately. The hardening effect in preirritated skin after a 4-week interval was also evaluated. Detergent, disinfectant and disinfectant/detergent alternately were applied daily every 15 min for 6 h for 2 days to the flexor upper arms and forearms of 15 volunteers. A control area was included. After 4 weeks, a sodium lauryl sulfate patch was applied to each area. Irritant reactions were quantified by visual score, transepidermal water loss (TEWL) and skin colour at baseline, D3, D8, D35 and D37. As evaluated by clinical assessment, detergent caused more redness of the skin than both disinfectant applied alone and disinfectant/detergent alternately at D3 and D8, P < 0.001 and P < 0.001, respectively. An increased irritant response for detergent as compared to disinfectant alone and disinfectant/detergent was confirmed by TEWL and colour evaluations, P = 0.001 and P = 0.001 and P = 0.006 and P = 0.009, respectively. No hardening effect in preirritated skin was found after a 4-week interval. In conclusion, hand disinfection with alcohol-based disinfectant or alternate use of disinfectant/detergent causes less skin irritation than hand disinfection with a detergent. This study evaluated the short-term effects of disinfectant and detergent exposure only, and more long-term studies are necessary before recommendations can be made.

Influence of a detergent on skin response to methyldibromo glutaronitrile in sensitized individuals.

The present study was undertaken to evaluate the combined effect of the preservative methyldibromo glutaronitrile (MDBGN) and sodium lauryl sulfate (SLS) on the elicitation response of allergic contact dermatitis. 20 volunteers with contact allergy to MDBGN were patch tested with 5 concentrations (10, 50, 100, 500 and 1000 p.p.m.) of MDBGN alone and in combination with 0.25% SLS on the upper arms for 24 h. Skin reactions were evaluated by clinical scoring, and data were evaluated by logistic dose-response models. Additionally, evaluation of skin reactions was performed by measurement of transepidermal water loss (TEWL) and skin colour. Measurements were obtained at baseline and at D3 and D7. As evaluated by clinical assessment, allergic reactions to MDBGN were elicited at lower concentrations when applied in combination with SLS than when applied alone. The response was augmented by a factor of 6.4. An increased response to combined exposure to SLS and MDBGN as compared with MDBGN alone was confirmed by TEWL and colour measurements. Effects of exposure time and concentration of the detergent are discussed. In conclusion, an augmented response was found after concurrent application of MDBGN and SLS. The response was augmented by a factor of 6.4, with confidence limits of 2.8-14.6 (P < 0.0001). This result is important in relation to the determination of threshold values and the risk assessment of contact allergens in consumer and industrial products, where allergens are often present in combination with surfactants.

Augmentation of skin response by exposure to a combination of allergens and irritants - a review.

Clinical experimental studies on contact dermatitis (CD) often evaluate the effect of one allergen or one irritant at a time. In real life, the skin is often exposed to more allergens, more irritants or allergens and irritants in combination. This combined exposure may potentially influence irritant effects as well as allergenicity of the substances. Mechanisms for a changed response can be immunological effects or enhanced penetration. Knowledge about the influence on skin reaction of combined exposures may influence skin reactivity and is important for prevention of CD. For allergens, threshold values may be influenced by the presence of other allergens or irritants, and prevention of CD by regulation of threshold values may not be sufficient if this is not taken into account.