348 results found
Pemberton JS, Wilmot EG, Barnard-Kelly K, et al., 2023, CGM accuracy: Contrasting CE marking with the governmental controls of the USA (FDA) and Australia (TGA): A narrative review., Diabetes Obes Metab, Vol: 25, Pages: 916-939
The National Institute for Clinical Excellence updated guidance for continuous glucose monitoring (CGM) in 2022, recommending that CGM be available to all people living with type 1 diabetes. Manufacturers can trade in the UK with Conformité Européenne (CE) marking without an initial national assessment. The regulatory process for CGM CE marking, in contrast to the Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA) process, is described. Manufacturers operating in the UK provided clinical accuracy studies submitted for CE marking. Critical appraisal of the studies shows several CGM devices have CE marking for wide-ranging indications beyond available data, unlike FDA and TGA approval. The FDA and TGA use tighter controls, requiring comprehensive product-specific clinical data evaluation. In 2018, the FDA published the integrated CGM (iCGM) criteria permitting interoperability. Applying the iCGM criteria to clinical data provided by manufacturers trading in the UK identified several study protocols that minimized glucose variability, thereby improving CGM accuracy on all metrics. These results do not translate into real-life performance. Furthermore, for many CGM devices available in the UK, accuracy reported in the hypoglycaemic range is below iCGM standards, or measurement is absent. We offer a framework to evaluate CGM accuracy studies critically. The review concludes that FDA- and TGA-approved indications match the available clinical data, whereas CE marking indications can have discrepancies. The UK can bolster regulation with UK Conformity Assessed marking from January 2025. However, balanced regulation is needed to ensure innovation and timely technological access are not hindered.
Oliver N, 2023, Screen test., Diabet Med, Vol: 40
Oliver N, Kingston S, Heyvaert V, et al., 2023, Climate of change, EUROPEAN ENVIRONMENTAL LAW, Publisher: WILEY, Pages: 257-297, ISBN: 978-1-107-64044-3
Avari P, Eng PC, Hu M, et al., 2023, A novel somatic mutation implicates ATP6V0D1 in proinsulin processing, Journal of the Endocrine Society, Vol: 7, Pages: 1-5, ISSN: 2472-1972
ContextProhormone convertase 1/3 (PC1/3), encoded by protein convertase subtilisin kexin type 1 (PCSK1), converts inactive prohormones into biologically active peptides. Somatic mutations of insulinomas are associated with genetic defects interfering with control of insulin secretion from pancreatic beta cells. However, somatic mutations in proinsulinomas have not been described.ObjectiveWe report a case of a proinsulinoma, with suppressed insulin and C-peptide levels.MethodsA 70-year-old woman presented with a 20-year history of “blackouts.” During a 72-hour fast, blood glucose level dropped to 1.9 mmol/L with suppressed plasma insulin and C-peptide levels, but proinsulin levels were raised at 37 pmol/L (<10 pmol/L).ResultsImaging revealed 3 distinct DOTATATE-avid pancreatic lesions. Laparoscopic spleen-preserving distal pancreatomy was performed. In view of discordant insulin, C-peptide, and proinsulin levels, whole exome sequencing analysis was performed on the tumor. In the somatic exome of the tumor, we found mutations in PCSK expression regulators, as well as a novel truncating somatic mutation in ATP6V0D1, a subunit of the ion pump that acidifies the β-cell compartments where the PCSKs act.ConclusionAppropriately suppressed insulin levels in the context of hypoglycemia do not always indicate the absence of a neuroendocrine islet cell tumor and proinsulin levels may be indicated to solidify the diagnosis. In the context of elevated proinsulin levels, low insulin and C-peptide levels might be explained by somatic mutations that likely implicate proinsulin processing within the tumor. Furthermore, we propose several mechanistic candidates, including ATP6V0D1. Experimental validation using cellular approaches may in future confirm pathomechanisms involved in this rare condition.
Avari P, O'Regan A, Preechasuk L, et al., 2023, Adjustment of Maternal Variable Rate Insulin Infusions Using Real-Time Continuous Glucose Monitoring in Pregnant Women with Type 1 Diabetes, DIABETES TECHNOLOGY & THERAPEUTICS, ISSN: 1520-9156
Oliver N, Chow E, Luk AOY, et al., 2023, Applications of continuous glucose monitoring across settings and populations: Report from the 23rd Hong Kong diabetes and cardiovascular risk factors-East meets west symposium, DIABETIC MEDICINE, ISSN: 0742-3071
Oliver N, 2023, Through the ages., Diabet Med, Vol: 40
Oliver N, 2023, No mean feat, DIABETIC MEDICINE, Vol: 40, ISSN: 0742-3071
Oliver N, 2022, Diabetes Therapy Podcast: Real-World Data for Glucose Sensing Technologies in Type 1 Diabetes, DIABETES THERAPY, Vol: 14, Pages: 1-10, ISSN: 1869-6953
Shah VN, Akturk HK, Vigers T, et al., 2022, Relationship Between Daytime Versus Nighttime Continuous Glucose Monitoring Metrics with A1C in Adults with Type 1 Diabetes, DIABETES TECHNOLOGY & THERAPEUTICS, Vol: 25, Pages: 62-68, ISSN: 1520-9156
Thomas NJ, Walkey HC, Kaur A, et al., 2022, The relationship between islet autoantibody status and the genetic risk of type 1 diabetes in adult-onset type 1 diabetes, DIABETOLOGIA, Vol: 66, Pages: 310-320, ISSN: 0012-186X
- Author Web Link
- Citations: 1
Rilstone S, Spurway P, Oliver N, et al., 2022, Nutritional support for a person with type 1 diabetes undertaking endurance swimming, FRONTIERS IN ENDOCRINOLOGY, Vol: 13, ISSN: 1664-2392
Oliver N, 2022, Finding positives, DIABETIC MEDICINE, Vol: 39, ISSN: 0742-3071
Oliver N, 2022, Fuelling inequality, DIABETIC MEDICINE, Vol: 39, ISSN: 0742-3071
Fallon C, Jones E, Oliver N, et al., 2022, The impact of socio-economic deprivation on access to diabetes technology in adults with type 1 diabetes., Diabet Med, Vol: 39
BACKGROUND: With advances in technology, there is an emerging concern that inequalities exist in provision and diabetes outcomes in areas of greater deprivation. We assess the relationship between socio-economic status and deprivation with access to diabetes technology and their outcomes in adults with type 1 diabetes. METHODS: Retrospective, observational analysis of adults attending a tertiary centre, comprising three urban hospitals in the UK. Socio-economic deprivation was assessed by the English Indices of Deprivation 2019. Data analysis was performed using one-way ANOVAs and chi-squared tests. RESULTS: In total, 1631 adults aged 44 ± 15 years and 758 (47%) women were included, with 391 (24%) using continuous subcutaneous insulin infusion, 312 (19%) using real-time continuous glucose monitoring and 558 (34%) using intermittently scanned continuous glucose monitoring. The highest use of diabetes technology was in the least deprived quintile compared to the most deprived quintile (67% vs. 45%, respectively; p < 0.001). HbA1c outcomes were available in 400 participants; no association with deprivation was observed (p = 0.872). Participation in structured education was almost twice as high from the most deprived to the least deprived groups (23% vs. 43%; p < 0.001). Adults with white or mixed ethnicity were more likely to use technology compared to black ethnicity (60% vs. 40%; p < 0.001). CONCLUSIONS: Adults living in the most deprived quintile had less technology use. Irrespective of socio-economic status or ethnicity, glycaemia was positively affected in all groups. It is imperative that health disparities are further addressed.
Sourij C, Aziz F, Kojzar H, et al., 2022, Severe acute respiratory syndrome coronavirus 2 spike antibody level decline is more pronounced after the second vaccination, but response to the third vaccination is similar in people with type 1 and type 2 diabetes compared with healthy controls: The prospective COVAC-DM cohort study, DIABETES OBESITY & METABOLISM, ISSN: 1462-8902
Acciaroli G, van der Linden J, Chao C, et al., 2022, Longitudinal analysis of users transitioning from the Dexcom G5 to the G6 RT-CGM system in Germany, Sweden and the United Kingdom (2018-2020), DIABETIC MEDICINE, ISSN: 0742-3071
Grace SL, Bowden J, Walkey HC, et al., 2022, Islet Autoantibody Level Distribution in Type 1 Diabetes and Their Association With Genetic and Clinical Characteristics, JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM, Vol: 107, Pages: E4341-E4349, ISSN: 0021-972X
Oliver N, 2022, Learning a language, DIABETIC MEDICINE, Vol: 39, ISSN: 0742-3071
Smith S, Normahani P, Lane T, et al., 2022, Prevention and management strategies for diabetic neuropathy, Life, Vol: 12, Pages: 1185-1185, ISSN: 2075-1729
Diabetic neuropathy (DN) is a common complication of diabetes that is becoming an increasing concern as the prevalence of diabetes rapidly rises. There are several types of DN, but the most prevalent and studied type is distal symmetrical polyneuropathy, which is the focus of this review and is simply referred to as DN. It can lead to a wide range of sensorimotor and psychosocial symptoms and is a major risk factor for diabetic foot ulceration and Charcot neuropathic osteoarthropathy, which are associated with high rates of lower limb amputation and mortality. The prevention and management of DN are thus critical, and clinical guidelines recommend several strategies for these based on the best available evidence. This article aims to provide a narrative review of DN prevention and management strategies by discussing these guidelines and the evidence that supports them. First, the epidemiology and diverse clinical manifestations of DN are summarized. Then, prevention strategies such as glycemic control, lifestyle modifications and footcare are discussed, as well as the importance of early diagnosis. Finally, neuropathic pain management strategies and promising novel therapies under investigation such as neuromodulation devices and nutraceuticals are reviewed.
Oliver N, 2022, Unprecedented?, DIABETIC MEDICINE, Vol: 39, ISSN: 0742-3071
Distaso W, Malik MMAH, Semere S, et al., 2022, Diabetes self-management during the COVID-19 pandemic and its associations with COVID-19 anxiety syndrome, depression and health anxiety, Publisher: WILEY, ISSN: 0742-3071
- Author Web Link
- Citations: 2
Smith S, Normahani P, Lane T, et al., 2022, Pathogenesis of distal symmetrical polyneuropathy in diabetes, Life, Vol: 12, Pages: 1-16, ISSN: 2075-1729
Distal symmetrical polyneuropathy (DSPN) is a serious complication of diabetes associated with significant disability and mortality. Although more than 50% of people with diabetes develop DSPN, its pathogenesis is still relatively unknown. This lack of understanding has limited the development of novel disease-modifying therapies and left the reasons for failed therapies uncertain, which is critical given that current management strategies often fail to achieve long-term efficacy. In this article, the pathogenesis of DSPN is reviewed, covering pathogenic changes in the peripheral nervous system, microvasculature and central nervous system (CNS). Furthermore, the successes and limitations of current therapies are discussed, and potential therapeutic targets are proposed. Recent findings on its pathogenesis have called the definition of DSPN into question and transformed the disease model, paving the way for new research prospects.
Oliver N, 2022, Prevention, DIABETIC MEDICINE, Vol: 39, ISSN: 0742-3071
Fallon C, Jones E, Oliver N, et al., 2022, The impact of socio-economic deprivation on access to diabetes technology in adults with type 1 diabetes, Publisher: WILEY, Pages: A212-A212, ISSN: 0742-3071
- Author Web Link
- Citations: 1
Akturk HK, Herrero P, Oliver N, et al., 2022, Impact of Different Types of Data Loss on Optimal Continuous Glucose Monitoring Sampling Duration, DIABETES TECHNOLOGY & THERAPEUTICS, Vol: 24, Pages: 749-753, ISSN: 1520-9156
- Author Web Link
- Citations: 4
Zhu T, Uduku C, Li K, et al., 2022, Enhancing self-management in type 1 diabetes with wearables and deep learning, npj Digital Medicine, Vol: 5, ISSN: 2398-6352
People living with type 1 diabetes (T1D) require lifelong selfmanagement to maintain glucose levels in a safe range. Failure to do socan lead to adverse glycemic events with short and long-term complications. Continuous glucose monitoring (CGM) is widely used in T1Dself-management for real-time glucose measurements, while smartphoneapps are adopted as basic electronic diaries, data visualization tools, andsimple decision support tools for insulin dosing. Applying a mixed effectslogistic regression analysis to the outcomes of a six-week longitudinalstudy in 12 T1D adults using CGM and a clinically validated wearablesensor wristband (NCT ID: NCT03643692), we identified several significant associations between physiological measurements and hypo- andhyperglycemic events measured an hour later. We proceeded to developa new smartphone-based platform, ARISES (Adaptive, Real-time, and Intelligent System to Enhance Self-care), with an embedded deep learning algorithm utilizing multi-modal data from CGM, daily entries of mealand bolus insulin, and the sensor wristband to predict glucose levels andhypo- and hyperglycemia. For a 60-minute prediction horizon, the proposed algorithm achieved the average root mean square error (RMSE)of 35.28±5.77 mg/dL with the Matthews correlation coefficients fordetecting hypoglycemia and hyperglycemia of 0.56±0.07 and 0.70±0.05,respectively. The use of wristband data significantly reduced the RMSEby 2.25 mg/dL (p < 0.01). The well-trained model is implemented onthe ARISES app to provide real-time decision support. These resultsindicate that the ARISES has great potential to mitigate the risk ofsevere complications and enhance self-management for people with T1D.
Daultrey H, Levett T, Wright J, et al., 2022, Is There a Discrepancy between Interstitial Glucose and Laboratory HbA1c in People Living with HIV?, Publisher: AMER DIABETES ASSOC, ISSN: 0012-1797
Oliver N, 2022, It's complicated, DIABETIC MEDICINE, Vol: 39, ISSN: 0742-3071
Hudson J, Cruickshank M, Quinton R, et al., 2022, Adverse cardiovascular events and mortality in men during testosterone treatment: an individual patient and aggregate data meta-analysis., The Lancet Healthy Longevity, Vol: 3, Pages: e381-e393, ISSN: 2666-7568
Background: Testosterone is the standard treatment for male hypogonadism, but there is uncertainty about its cardiovascular safety due to inconsistent findings. We aimed to provide the most extensive individual participant dataset (IPD) of testosterone trials available, to analyse subtypes of all cardiovascular events observed during treatment, and to investigate the effect of incorporating data from trials that did not provide IPD. Methods: We did a systematic review and meta-analysis of randomised controlled trials including IPD. We searched MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, MEDLINE Epub Ahead of Print, Embase, Science Citation Index, the Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, and Database of Abstracts of Review of Effects for literature from 1992 onwards (date of search, Aug 27, 2018). The following inclusion criteria were applied: (1) men aged 18 years and older with a screening testosterone concentration of 12 nmol/L (350 ng/dL) or less; (2) the intervention of interest was treatment with any testosterone formulation, dose frequency, and route of administration, for a minimum duration of 3 months; (3) a comparator of placebo treatment; and (4) studies assessing the pre-specified primary or secondary outcomes of interest. Details of study design, interventions, participants, and outcome measures were extracted from published articles and anonymised IPD was requested from investigators of all identified trials. Primary outcomes were mortality, cardiovascular, and cerebrovascular events at any time during follow-up. The risk of bias was assessed using the Cochrane Risk of Bias tool. We did a one-stage meta-analysis using IPD, and a two-stage meta-analysis integrating IPD with data from studies not providing IPD. The study is registered with PROSPERO, CRD42018111005. Findings: 9871 citations were identified through database searches and after exclusion of duplicates and of irrelevant citations, 225
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