Citations

The development of automated insulin delivery systems has seen tremendous improvements from individual components to interoperable system combinations of devices and new drugs besides insulin. The components have become progressively smaller, more accurate, and more user friendly. This article summarizes the history of the artificial pancreas from the earliest concepts to fully functional systems to research into further improvements in the future. The authors include many of the developers of this technology who received research support from the National Institute of Diabetes and Digestive and Kidney Diseases at various stages to develop these systems.

The development of automated insulin delivery systems has seen tremendous improvements from individual components to interoperable system combinations of devices and new drugs besides insulin. The components have become progressively smaller, more accurate, and more user friendly. This article summarizes the history of the artificial pancreas from the earliest concepts to fully functional systems to research into further improvements in the future. The authors include many of the developers of this technology who received research support from the National Institute of Diabetes and Digestive and Kidney Diseases at various stages to develop these systems.

Objective To develop new antiphospholipid syndrome (APS) classification criteria with high specificity for use in observational studies and trials, jointly supported by the American College of Rheumatology (ACR) and EULAR. Methods This international multidisciplinary initiative included 4 phases: 1) Phase I, criteria generation by surveys and literature review; 2) Phase II, criteria reduction by modified Delphi and nominal group technique exercises; 3) Phase III, criteria definition, further reduction with the guidance of real‐world patient scenarios, and weighting via consensus‐based multicriteria decision analysis, and threshold identification; and 4) Phase IV, validation using independent adjudicators’ consensus as the gold standard. Results The 2023 ACR/EULAR APS classification criteria include an entry criterion of at least one positive antiphospholipid antibody (aPL) test within 3 years of identification of an aPL‐associated clinical criterion, followed by additive weighted criteria (score range 1–7 points each) clustered into 6 clinical domains (macrovascular venous thromboembolism, macrovascular arterial thrombosis, microvascular, obstetric, cardiac valve, and hematologic) and 2 laboratory domains (lupus anticoagulant functional coagulation assays, and solid‐phase enzyme‐linked immunosorbent assays for IgG/IgM anticardiolipin and/or IgG/IgM anti–β 2 ‐glycoprotein I antibodies). Patients accumulating at least 3 points each from the clinical and laboratory domains are classified as having APS. In the validation cohort, the new APS criteria versus the 2006 revised Sapporo classification criteria had a specificity of 99% versu s 86%, and a sensitivity of 84% versus 99%. Conclusion These new ACR/EULAR APS classification criteria were developed using rigorous methodology with multidisciplinary international input. Hierarchically clustered, weighted, and risk‐stratified criteria reflect the current thinking about APS, providing high specificity and a strong foundation for future APS research.

OBJECTIVE Laminoplasty is a common treatment for cervical spondylotic myelopathy (CSM) and for ossification of the posterior longitudinal ligament (OPLL). However, approximately 21% of patients undergoing laminoplasty develop cervical kyphotic deformity (KD). Because of the high prevalence rate of KD, several studies have sought to identify predictors for this complication, but the findings remain highly inconsistent. Therefore, the authors performed a systematic review and meta-analysis to establish reliable preoperative predictors of KD. METHODS PubMed, Scopus, and Web of Science databases were used to systematically extract potential references. The first phase of screening required the studies to be written in the English language, involve patients treated for CSM and/or OPLL via laminoplasty, and report postoperative cervical KD. The second phase required the studies to provide more than 10 patients and include a control group. The mean difference (MD) and odds ratio (OR) were calculated for continuous and dichotomous parameters. Study quality was evaluated using the Newcastle-Ottawa Scale. CSM and OPLL patients were further assessed by performing subgroup analyses. RESULTS Thirteen studies comprising patients who developed cervical KD (n = 296) and no KD (n = 1254) after receiving cervical laminoplasty for CSM or OPLL were included in the meta-analysis. All studies were retrospective cohorts and were rated as high quality. In the combined univariate analysis of CSM and OPLL patients undergoing laminoplasty, statistically significant predictors for postoperative KD included age (MD 2.22, 95% CI 0.16–4.27, p = 0.03), preoperative BMI (MD 0.85, 95% CI 0.06–1.63, p = 0.04), preoperative C2–7 range of flexion (MD 10.42, 95% Cl 4.24–16.59, p = 0.0009), preoperative C2–7 range of extension (MD −4.59, 95% CI −6.34 to −2.83, p < 0.00001), and preoperative center of gravity of the head to the C7 sagittal vertical axis (MD 26.83, 95% CI 9.13–44.52, p = 0.003). Additionally, among CSM patients, males were identified as having a greater risk for postoperative KD (OR 1.73, 95% CI 1.02–2.93, p = 0.04). CONCLUSIONS The findings from this study currently provide the largest and most reliable review on preoperative predictors for cervical KD after laminoplasty. Given that several of the included studies identified optimal cutoff points for the variables that are significantly associated with KD, further investigation into the development of a preoperative risk scoring system that can accurately predict KD in the clinical setting is encouraged. PROSPERO registration no.: CRD42022299795 ( https://www.crd.york.ac.uk/PROSPERO/ ).

Background: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data. Methods: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low–glucose and low-glucose hypoglycemia; very high–glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation. Results: The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals. Conclusion: The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

Background: Compared with multiple daily injections (MDI), sensor-augmented pump (SAP) insulin therapy may reduce glycemic variability and oxidative stress in type 1 diabetes in a glycosylated hemoglobin (A1C)-independent manner. Subjects and Methods: The STAR 3 study compared SAP with MDI therapy for 1 year. Week-long continuous glucose monitoring studies were conducted at baseline and 1 year for assessment of glycemic variability in both groups. Soluble CD40 ligand (CD40L), a biomarker of inflammation and thrombocyte function, was measured at baseline and 1 year. Subjects were classified according to treatment group and 1-year A1C levels (<6.5%, 6.5–6.9%, 7–7.9%, ≥8%). Glycemic parameters were compared between SAP and MDI subjects in each A1C cohort. Results: At 1 year, sensor glucose values at A1C levels ≥6.5% were similar in the SAP and MDI groups. However, sensor glucose SD and coefficient of variation (CV) values were lower at A1C levels <8% among SAP than among MDI subjects; the overall between-group difference was significant for both SD ( P <0.01) and CV ( P =0.01). The overall mean amplitude of glycemic excursion was similar in MDI and SAP groups ( P =0.23). CD40L levels fell over the course of the study in both groups, but the between-group difference was not significant ( P =0.18). CD40L concentrations were unrelated to A1C, change in A1C from baseline, or glycemic variability. Conclusions: At comparable A1C levels of <8%, SAP reduced glycemic variability as measured by SD and CV compared with MDI. SAP may provide beneficial reductions in the number and severity of glycemic excursions.