Comparison of the injection-site experience of semaglutide in a single-dose and a multidose pen-injector.
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ABSTRACT:
SUBMITTER: Snitker S
PROVIDER: S-EPMC9545130 | biostudies-literature | 2022 Aug
REPOSITORIES: biostudies-literature
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Comparison of the injection-site experience of semaglutide in a single-dose and a multidose pen-injector.
Snitker Søren S Andersen Andreas A Lindskov Pernille Skøtt PS van Marle Sjoerd S Sode Birgitte Fischer BF Sparre Thomas T
Diabetes, obesity & metabolism 20220520 8
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Project description: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.
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| S-EPMC9805145 | biostudies-literature
Project description:This double-blind, randomized, single-site, crossover trial compared the injection-site experience with the starting doses of semaglutide and dulaglutide. Healthy subjects (aged 18-75 years; body mass index ≥ 25 kg/m2 ; n = 104) were randomized 1:1, using a pregenerated list, to semaglutide 0.25 mg as the first injection and dulaglutide 0.75 mg as the second injection or vice versa; each was administered using their proprietary pen-injectors, according to instructions for use. The primary endpoint was intensity of injection-site pain, measured using a visual analogue scale (VAS; 0 mm = no pain, 100 mm = unbearable pain). Exploratory endpoints included intensity category, duration and quality of injection-site pain, and comparative assessment of injection-site pain with the two injections. The point estimate of the VAS score for injection-site pain intensity was 11.5 mm with dulaglutide versus 5.6 mm with semaglutide; mean (95% confidence interval) estimated treatment difference 5.9 (3.6; 8.2) mm; p < .0001. Other endpoints corroborated a less painful injection experience with semaglutide versus dulaglutide. Safety was consistent with reported data for the drugs. In conclusion, the injection-site experience with semaglutide was rated as less painful than that with dulaglutide.
| S-EPMC8251561 | biostudies-literature
Project description:PURPOSE:We present ultrasound-guided percutaneous low-dose thrombin (200-250 IU) injection for the treatment of iatrogenic femoral pseudoaneurysms. Second, we compared patient and procedure factors between subcutaneous hematoma and pseudoaneurysm groups. MATERIALS AND METHODS:From April 2012 to May 2018, 8425 patients underwent neurointervention. Among these patients, 18 had small subcutaneous hematomas and 6 had pseudoaneurysms. Pseudoaneurysms in the neck and entire sac were visualized, and low-dose thrombins were injected while visualizing a "whirlpool" hyperechoic core in the pseudoaneurysm sac. Subcutaneous hematomas were treated with simple compression. We compared the following parameters between the subcutaneous hematoma group and pseudoaneurysm group: sex, age, body mass index (BMI), type of procedure, heparin usage, sheath size, procedure time, and number of previous neurointervention procedures with the Mann-Whitney U test. RESULTS:Most of the pseudoaneurysms were successfully occluded with 200 IU of thrombin (n=5). Only 1 pseudoaneurysm required a slightly higher thrombin concentration (250 IU, n=1). During the short-term follow-up, no residual sac was observed and no surgical repair was necessary. Pain in the groin region was alleviated. During the 1-month follow-up, no evidence of pseudoaneurysm recurrence nor subcutaneous hematoma was noted. Patient factors (sex, age, and BMI) and procedure factors (heparin usage, sheath size, procedure time, number of previous procedures) were not statistically different between the subcutaneous hematoma and pseudoaneurysm groups. CONCLUSION:Ultrasound-guided percutaneous low-dose thrombin injection (200-250 IU) is safe, effective, and less invasive for treating iatrogenic femoral pseudoaneurysm in neurointervention.
| S-EPMC7105095 | biostudies-literature
Project description:ObjectiveTo explore the effects of oral semaglutide on glycaemic parameters, body weight, and satisfaction in the first recipient patients with type 2 diabetes mellitus in Slovenia, in a real-world clinical practice setting.MethodsThe first consecutive adult patients with type 2 diabetes who were eligible for oral semaglutide treatment were included in this prospective, open-label interventional study. Patients received increasing doses of oral semaglutide and were evaluated at inclusion, at 1 month, then 3-5 months after starting treatment. Fasting blood glucose, glycosylated haemoglobin (HbA1c), body weight, patient satisfaction with oral semaglutide treatment (using the validated Treatment Satisfaction Questionnaire for Medication), and adverse effects, were analysed. Statistical analyses were performed using one-way analysis of variance, and, when significant interactions were found, Bonferroni post-hoc test. A P-value <0.05 was considered statistically significant.ResultsTwenty patients (11 male: 9 female; mean age, 59.9 ± 1.5 years; mean diabetes duration, 8.5 ± 1.4 years) were included. Oral semaglutide (7 and 14 mg) significantly decreased HbA1c (from 9.4 ± 0.3% to 8.2 ± 0.2% and 7.8 ± 0.2%, respectively) and fasting plasma glucose (from 11.2 ± 0.5 mmol/L to 9.2 ± 0.7 mmol/L and 8.9 ± 0.4 mmol/L, respectively). Oral semaglutide (14 mg) significantly decreased body weight (from 100.9 ± 2.7 kg to 92.7 ± 2.4 kg). Patients reported that treatment was easy to use and expressed high global satisfaction. Mild and transient, mostly gastrointestinal, adverse effects were reported in 10 patients.ConclusionsOral semaglutide, the first oral glucagon-like peptide 1 receptor agonist, was effective and safe, and associated with high patient satisfaction, in its first recipients in Slovenia. The results are important for daily clinical practice involving patients with type 2 diabetes, however, due to the small study population, lack of placebo control, and short exposure to oral semaglutide, the effectiveness of oral semaglutide in clinical practice requires further investigation.
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Project description:ASS lime injection - injection site
| PRJEB6137 | ENA
Project description:Spin injection, manipulation and detection are the integral parts of spintronics devices and have attracted tremendous attention in the last decade. It is necessary to judiciously choose the right combination of materials to have compatibility with the existing semiconductor technology. Conventional metallic magnets were the first choice for injecting spins into semiconductors in the past. Here we demonstrate the electrical spin injection from an oxide magnetic material Fe3O4, into GaAs with the help of tunnel barrier MgO at room temperature using 3-terminal Hanle measurement technique. A spin relaxation time τ ~ 0.9 ns for n-GaAs at 300 K is observed along with expected temperature dependence of τ. Spin injection using Fe3O4/MgO system is further established by injecting spins into p-GaAs and a τ of ~0.32 ns is obtained at 300 K. Enhancement of spin injection efficiency is seen with barrier thickness. In the field of spin injection and detection, our work using an oxide magnetic material establishes a good platform for the development of room temperature oxide based spintronics devices [corrected].
| S-EPMC4083262 | biostudies-literature
Project description:Giant magnetostrictive injector using giant magnetostrictive material acting an electronic controlled injector may be one new promising injector to acquire adjustable injection rates while maintaining large injection quantity. An electronic controlled injector driven by a giant magnetostrictive actuator was designed through combining the driving requirement and output characteristics of the material. To promote responding speed of the coil current, the driving voltage with open-hold-fall type waveform was employed just like using in an electromagnetic injector. Simulation model for the injection characteristic of the injector was established using AMEsim software and verified using experimental results collected by the single injection meter. From simulation and experimental results, designed giant magnetostrictive injector showed good performances as maximum spray rate of 4.5 L/min and minimum spray pulse width of 0.21 ms, and realized the boot shape injection when generated by the designed voltage wave. Furthermore, duration time and amplitude of the pilot spray part in a boot shape injection were respectively adjusted through changing the dwell time and opening time. The boot shape injection reached by the giant magnetostrictive injector can reach quite accurate control of fuel injection and then promote fuel efficiency effectively.
| S-EPMC8626452 | biostudies-literature
Project description:IntroductionOctreotide acetate subcutaneous injection is indicated to treat acromegaly and the symptoms of carcinoid tumors and vasoactive intestinal peptide tumors (VIPomas). This formative human factors study assessed the octreotide acetate pen injector and accompanying instructions for use (IFU) with self-trained participants.MethodsThe study enrolled patients with diagnoses of acromegaly, carcinoid tumors, or VIPomas and healthcare practitioners (HCPs) who treat patients with these diagnoses. The IFU provided a stepwise process with illustrations to train participants on using the pen injector. Participants familiarized themselves with the pen injector and the IFU before administering 2 unaided injections into skin-like pads; administering the full dose into the pad was considered a successful injection. The investigators evaluated each injection by performance measures-specific tasks necessary to safely and correctly administer the medication-and subjective measures, which included participant comments, feedback from questions, and suggestions for improvements.ResultsThe study enrolled 11 participants-8 patients and 3 HCPs. Participants had a success rate of 100% for both injections. Errors included 1 participant priming the pen with the incorrect dose and 2 participants not holding the injector button for 10 s after the injection. Neither error led to a failed injection. To improve the IFU, participants suggested changing the order of wording on the priming step, clarifying illustrations of the plunger, and stronger indications to hold the injector button.ConclusionThe octreotide pen injector and IFU were usable by self-trained participants. Participant errors and suggestions provided a foundation for recommendations to improve the IFU.
| S-EPMC8189973 | biostudies-literature
Project description:BackgroundInsulin glargine 300 U/mL (Gla-300) contains the same active ingredient as glargine 100 U/mL (Gla-100), and provides the same number of units in one-third of the volume. The SoloSTAR® injector pen has been modified to ensure accurate administration of this reduced volume and to improve user experience.MethodsInsulin- and pen-naïve adults with type 2 diabetes (T2DM) inadequately controlled with oral antihyperglycemic drugs, who had glycated hemoglobin (HbA1c) levels of 7.0-11.0 % (53-97 mmol/mol) were studied. They received once-daily Gla-300 in this 4-week, multicenter, open-label, single-arm study (NCT02227212). Ease of use/ease of learning (the primary endpoint), glycemic control, safety, and reliability of the disposable (prefilled) Gla-300 injector pen (secondary endpoints) were evaluated.ResultsAt week 4, 95.0% of 40 participating subjects assessed the pen as excellent/good and none as poor/very poor; 97.5% would recommend it to others. Total Diabetes Treatment Satisfaction Questionnaire scores were stable throughout the study. Mean (SD) fasting plasma glucose levels decreased from 166.1 (35.0) mg/dL at baseline to 124.2 (41.1) mg/dL at week 4. No product technical complaints (PTCs) or adverse events (AEs) related to PTCs were reported. The number of subjects experiencing hypoglycemic events of any kind and the incidence of AEs were low. No serious AEs were reported.ConclusionsThe Gla-300 injector pen is easy to use and easy to learn to use, with demonstrable reliability and high degrees of acceptance and treatment satisfaction. Once-daily Gla-300 basal insulin treatment was well tolerated and effective in pen- and insulin-naïve adult T2DM subjects.
| S-EPMC5478028 | biostudies-literature