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The proliferation of digital technology has the potential to transform diabetes management. One of the critical aspects of modern diabetes management remains the achievement of glycemic targets to avoid acute and long-term complications. This study aims to describe the landscape of evidence pertaining to the relative effectiveness or efficacy and safety of various digital interventions for the self-management of type 2 diabetes mellitus (T2DM), with a primary focus on reducing glycated hemoglobin A (HbA ) levels. A systematic literature review (SLR) was conducted by searching Embase, MEDLINE, and CENTRAL on April 5, 2022. Study selection, data extraction, and quality assessment were performed by 2 independent reviewers. Eligibility criteria for the SLR included randomized controlled trials (RCTs) and comparative observational studies evaluating interventions containing both human (eg, coaching) and digital components (eg, glucose meter) in adult patients with T2DM. The primary meta-analysis was restricted to studies that reported laboratory-measured HbA . In secondary analyses, meta-regression was performed with the intensity of coaching in the digital intervention as a categorical covariate. In total, 28 studies were included in this analysis. Most studies (23/28, 82%) used the reduction of HbA levels as the primary end point, either directly or as a part of a multicomponent outcome. In total, 21 studies reported statistically significant results with this primary end point. When stratified into 3 intervention categories by the intensity of the intervention supporting the digital health technology (analyzing all 28 studies), the success rate appeared to be proportional to the coaching intensity (ie, higher-intensity studies reported higher success rates). When the analysis was restricted to RCTs using the comparative improvement of HbA levels, the effectiveness of the interventions was less clear. Only half (12/23, 52%) of the included RCTs reported statistically significant results. The meta-analyses were broadly aligned with the results of the SLR. The primary analysis estimated a greater reduction in HbA associated with digital interventions compared with usual care (-0.31%, 95% CI -0.45% to -0.16%; P<.001). Meta-regression estimated reductions of -0.45% (95% CI -0.81% to -0.09%; P=.02), -0.29% (95% CI -0.48% to -0.11%; P=.003), and -0.28% (95% CI -0.65% to 0.09%; P=.20) associated with high-, medium-, and low-intensity interventions, respectively. These findings suggest that reducing HbA levels in individuals with T2DM with the help of digital interventions is feasible, effective, and acceptable. One common feature of effective digital health interventions was the availability of timely and responsive personalized coaching by a dedicated health care professional.

In this study involving patients with type 1 diabetes, sensor-augmented insulin-pump therapy plus automated insulin suspension when glucose dropped below 70 mg per deciliter reduced nocturnal hypoglycemia, without affecting glycated hemoglobin values. Severe nocturnal hypoglycemia can be catastrophic, 1 , 2 and hypoglycemia remains one of the most formidable barriers to improving glycemic control in patients with diabetes. 3 Sensor-augmented insulin-pump therapy offers substantial glycemic benefits, as compared with multiple daily insulin injections, but has not been shown to lower the risk of severe hypoglycemia significantly. 4 The automatic suspension of insulin delivery when a preset sensor glucose threshold is reached has the potential to mitigate hypoglycemia. The low-glucose suspend feature, available in the Medtronic Paradigm Veo pump outside the United States since 2009, was used in this study in the intervention group; the feature allows . . .

Background This study aimed to assess the impact of 15 days before, 15 days during, and 15 days after the lockdown on the trends in the prevalence and mortality in 27 countries during COVID-19 pandemic. Methods Twenty-seven countries were randomly selected from the different continents. The information on the trends in the prevalence and mortality due to COVID-19 pandemic in 27 countries was obtained from World Health Organization and lockdown data were obtained from concerned countries and their ministries. The impact of lockdown for 15 days before, 15 days during, and 15 days after the lockdown on the prevalence and mortality due to the COVID-19 pandemic in 27 countries was analyzed. Results The findings showed that 15 days after the lockdown there was a trend toward a decline, but no significant decline in the mean prevalence and mean mortality rate due to the COVID-19 pandemic compared to 15 days before, and 15 days during the lockdown in 27 countries. The mean growth factor for number of cases was 1.18 and for mortality rate was 1.16. Conclusions The findings indicate that 15 days after the lockdown, daily cases of COVID-19 and the growth factor of the disease showed a declined trend, but there was no significant decline in the prevalence and mortality.

Human monkeypox is an emerging viral zoonotic disease, that has caused highly distinctive, challenging and threatening problems worldwide. The US Food and Drug Administration (FDA) has given interim authorization for the JYNNEOS and ACAM2000 vaccines for the outbreak of monkeypox 2022. The present study aims to highlight the globally derived evidence about the biological and pharmacological features, indications, contraindications and adverse effects of JYNNEOS and ACAM2000 vaccines. Initially, 82 documents were selected and, finally, 14 fact sheets, documents and international organizations were included. The data were recorded from the World Health Organization (WHO), Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) USA, ISI-Web of Science, PubMed, EMBASE and Scopus. The data revealed that the JYNNEOS vaccine has been recommended to children, adults, females during pregnancy and people of all age groups with a dose of 0.5 mL, and the complete vaccination cost per person is about USD 115. It provides immunogenicity, and the mean titer of neutralizing antibodies was 153.5. However, the ACAM2000 vaccine is contraindicated in infants and pregnant females, and recommended to people over 18 years of age and older, with a single dose of 0.0025 mL, and a cost of about USD 139. ACAM2000 provides immunogenicity, and the mean titer of neutralizing antibodies was 79.3. The JYNNEOS vaccine has mild adverse effects including pain, redness, swelling or itching at the site of the vaccine shot, fever, fatigue, headache, nausea and muscle pain. However, the ACAM2000 vaccine can cause pain, redness, edema, headache, fever, fatigue, muscle pain, body ache, nausea, vomiting, diarrhea, shortness of breath and increased risk of myopericarditis and cardiomyopathy. The evidence supports the view that both vaccines are beneficial, but the overall impact of JYNNEOS is better than that of ACAM2000.

Background The large language models (LLMs), most notably ChatGPT, released since November 30, 2022, have prompted shifting attention to their use in medicine, particularly for supporting clinical decision-making. However, there is little consensus in the medical community on how LLM performance in clinical contexts should be evaluated. Methods We performed a literature review of PubMed to identify publications between December 1, 2022, and April 1, 2024, that discussed assessments of LLM-generated diagnoses or treatment plans. Results We selected 108 relevant articles from PubMed for analysis. The most frequently used LLMs were GPT-3.5, GPT-4, Bard, LLaMa/Alpaca-based models, and Bing Chat. The five most frequently used criteria for scoring LLM outputs were “accuracy”, “completeness”, “appropriateness”, “insight”, and “consistency”. Conclusions The most frequently used criteria for defining high-quality LLMs have been consistently selected by researchers over the past 1.5 years. We identified a high degree of variation in how studies reported their findings and assessed LLM performance. Standardized reporting of qualitative evaluation metrics that assess the quality of LLM outputs can be developed to facilitate research studies on LLMs in healthcare.

Current regulatory frameworks in the United States (US) and the European Union (EU) provide medical data privacy protections, but do not explicitly establish ownership rights. Legislation increasingly recognizes the rights of persons with chronic diseases for data ownership, but clinicians, researchers, public health professionals, and medical device manufacturers can also stake claims to ownership. Effective translational medical research requires policies for using patient-generated data to help society while still protecting the rights of patients from whom the data was obtained. Four increasingly important areas related to the ownership of patient-generated research data are discussed in this article, including (1) US and European laws relating to medical data ownership, (2) stakeholders claiming ownership of medical data, (3) the need for ownership laws to support translational medicine research, and (4) emerging controversies in medical data ownership. Translational research requires secure and legal acquisition of data streams. Technological and policy strategies for data ownership are increasingly needed that respect the rights of all involved stakeholders. No specific legislation in the US and various EU Member States explicitly recognizes ownership rights of medical data. Recent regulatory initiatives like the Trusted Exchange Framework and Common Agreement (TEFCA) in the US and the European Health Data Space Regulation (EHDS) in European Union Member States have strengthened patients’ access to and control of their medical data, but they do not establish medical data ownership rights. The absence of clear ownership rules continues to raise ethical, technical, and legal challenges as medical data sharing expands across international borders.

Aims/Introduction A single‐dose, shield‐activated pen‐injector for each of the three approved dose variants (0.25, 0.5 and 1 mg) of once‐weekly subcutaneous semaglutide has been developed to improve usability. This analysis presents findings from the summative usability testing process for the single‐dose semaglutide pen‐injectors, including the pen‐injector four‐pack cartons and instructions for use. Materials and Methods A total of 60 adults representing four user groups were included: patients with/without pen‐injector experience, non‐pharmacist healthcare professionals and pharmacists (each n = 15). Participants carried out four tasks: (i) pen‐injector carton retrieval; (ii) first simulated injection; (iii) pen‐injector retrieval; and (iv) second simulated injection. All participants carried out task 1, and patients and non‐pharmacist healthcare professionals took part in tasks 2–4 (n = 45). The number and types of use errors, close calls and operational difficulties were evaluated, and participants subjectively rated the ease of each task on a scale of 1 (difficult) to 7 (easy). Results No potentially serious use errors and only one non‐serious use error were reported. Eight participants committed use errors with no potential for harm, one participant committed an unclassified use error, one participant encountered a close call with no potential for harm and one participant experienced an operational difficulty. Mean ease‐of‐use ratings were 6.7 (task 1), 5.9 (task 2), 6.6 (task 3) and 6.9 (task 4). Conclusions All three dose variants of the semaglutide single‐dose pen‐injector were considered easy to use (subjective feedback scores near 7) and not associated with any serious use errors, even when participants received no training before study participation. A single‐dose, shield‐activated pen‐injector for each of the three approved dose variants (0.25, 0.5 and 1 mg) of once‐weekly subcutaneous semaglutide has been developed to improve usability. This summative usability testing involved 60 adults, representing four intended pen‐injector user groups: patients with/without pen‐injector experience, non‐pharmacist healthcare professionals and pharmacists (n = 15 each). This study found that all three dose variants of the semaglutide single‐dose pen‐injector were considered easy to use and were not associated with any serious use errors, even when participants received no training before study participation. The instances of use errors and close calls were equal to the number of participants who committed each task failure type. All use errors and close calls were committed by patients except: †2 committed by non‐pharmacist healthcare professionals (HCPs); ‡committed by a non‐pharmacist HCP.

An assessment of the medical literature on continuous glucose monitoring available through the end of 2004 is presented. It discusses continuous glucose monitoring in terms of its purposes, technologies, target populations, accuracy, clinical indications, outcomes, and problems. In conclusion, continuous glucose monitoring offers advantages over intermittent glucose monitoring when glycemic patterns are poorly understood.

Regulatory agencies, such as the European Commission and the U.S. Food and Drug Administration, are now permitting electronic instructions for use (eIFUs) to be distributed alongside paper instructions for use (IFUs) for medical devices. However, challenges remain regarding the implementation of eIFUs to replace paper IFUs in the era of digital health. Our work examines regulatory, consumer, and environmental factors that influence the transition from paper-based IFUs to eIFUs for wearable diabetes devices.