Role of Continuous Glucose Monitoring in Clinical Trials: Recommendations on Reporting.

Thanks to significant improvements in the precision, accuracy, and usability of continuous glucose monitoring (CGM), its relevance in both ambulatory diabetes care and clinical research is increasing. In this study, we address the latter perspective and derive provisional reporting recommendations. CGM systems have been available since around the year 2000 and used primarily in people with type 1 diabetes. In contrast to self-measured glucose, CGM can provide continuous real-time measurement of glucose levels, alerts for hypoglycemia and hyperglycemia, and a detailed assessment of glycemic variability. Through a broad spectrum of derived glucose data, CGM should be a useful tool for clinical evaluation of new glucose-lowering medications and strategies. It is the only technology that can measure hyperglycemic and hypoglycemic exposure in ambulatory care, or provide data for comprehensive assessment of glucose variability. Other advantages of current CGM systems include the opportunity for improved self-management of glycemic control, with particular relevance to those at higher risk of or from hypoglycemia. We therefore summarize the current status and limitations of CGM from the perspective of clinical trials and derive suggested recommendations for how these should facilitate optimal CGM use and reporting of data in clinical research

Evidence supports prediabetes treatment

In his News Feature on prediabetes (“Dubious diagnosis,” 8 March, p. 1026), C. Piller asserts that prediabetes diagnoses and treatment may be ineffective and sullied by conflicts of interest. As current and former chairs of the American Diabetes Association’s (ADA’s) Professional Practice Committee [the group that reviews and updates the Standards of Medical Care in Diabetes (Standards) each year], we disagree. Prediabetes is a useful term to convey future risk of diabetes, and recommendations for diabetes prevention are based on best current evidence

Lattice Pseudospin Model for ν=1\nu=1 Quantum Hall Bilayers

We present a new theoretical approach to the study of $\nu=1$ quantum Hall bilayer that is based on a systematic mapping of the microscopic Hamiltonian to an anisotropic SU(4) spin model on a lattice. To study the properties of this model we generalize the Heisenberg model Schwinger boson mean field theory (SBMFT) of Arovas and Auerbach to spin models with anisotropy. We calculate the temperature dependence of experimentally observable quantities, including the spin magnetization, and the differential interlayer capacitance. Our theory represents a substantial improvement over the conventional Hartree-Fock picture which neglects quantum and thermal fluctuations, and has advantages over long-wavelength effective models that fail to capture important microscopic physics at all realistic layer separations. The formalism we develop can be generalized to treat quantum Hall bilayers at filling factor $\nu=2$.Comment: 26 pages, 10 figures. The final version, to appear in PR

Bringing closure: towards achieving a better understanding of Israel

We wholeheartedly endorse Richard Horton’s timely Comment, in which he addresses the global rise of anti-Semitism particularly evident in Europe and the USA. Horton stresses the need to educate medical students and health-care professionals of the evil and disastrous consequences of ignoring the historical reality of the Holocaust. It will remind the world, 75 years on, that the call Never Again remains highly relevant

Comparing the efficacy, safety, and utility of intensive insulin algorithms for a primary care practice

Diabetes management is firmly based within the primary care community. Landmark randomized, controlled trials have demonstrated that even modest reductions in glycated hemoglobin (HbA1c) can yield improvements in economic and medical end-points. Diabetes is a chronic, progressive disease associated with loss of pancreatic β-cell function. Therefore, most patients will eventually require insulin therapies in order to achieve their individualized targeted HbA1c as their β-cell function and mass wanes. Although clinicians understand the importance of early insulin initiation, there is little agreement as to when to introduce insulin as a therapeutic option. Once initiated, questions remain as to whether to allow the patients to self-titrate their dose or whether the dosing should be tightly regulated by the clinician. Physicians have many evidence-based basal insulin protocols from which to choose, all of which have been shown to drive HbA1c levels to the American Diabetes Association target of ≤7%. This article will discuss ways by which insulin therapies can be effectively introduced to patients within busy primary care practices. Published evidence-based basal insulin protocols will be evaluated for safety and efficacy

Higgs and neutrino sector, EDM and epsilon_K in a spontaneously CP and R-parity breaking supersymmetric model

We construct an extension of the supersymmetric standard model where both CP symmetry and R-parity are spontaneously broken. We study the electroweak symmetry breaking sector of the model and find minima consistent with the experimental bounds on Higgs boson masses. Neutrino masses and mixing angles are generated through both seesaw and bilinear R-parity violation. We show that the hierarchical mass pattern is obtained, and mixings are consistent with measured values. Due to the spontaneous CP and R-parity violation, the neutrino sector is CP violating, and we calculate the corresponding phase. We further restrict the parameter space to agree with the limits on the electric dipole moment of the neutron. Finally, we study the CP violation parameter epsilon_K in the kaon system and show that we obtain results consistent with the experimental value.Comment: 13 pages, 7 figures, submitted to EPJ

Clinical targets for continuous glucose monitoring data interpretation : recommendations from the international consensus on time in range

Improvements in sensor accuracy, greater convenience and ease of use, and expanding reimbursement have led to growing adoption of continuous glucose monitoring (CGM). However, successful utilization of CGM technology in routine clinical practice remains relatively low. This may be due in part to the lack of clear and agreed-upon glycemic targets that both diabetes teams and people with diabetes can work toward. Although unified recommendations for use of key CGM metrics have been established in three separate peer-reviewed articles, formal adoption by diabetes professional organizations and guidance in the practical application of these metrics in clinical practice have been lacking. In February 2019, the Advanced Technologies & Treatments for Diabetes (ATTD) Congress convened an international panel of physicians, researchers, and individuals with diabetes who are expert in CGM technologies to address this issue. This article summarizes the ATTD consensus recommendations for relevant aspects of CGM data utilization and reporting among the various diabetes populations

The Discovery and Mass Measurement of a New Ultra-Short-Period Planet: K2-131b

FWN – Publicaties zonder aanstelling Universiteit LeidenStars and planetary system

Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes

BACKGROUND Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting. METHODS In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed. RESULTS A total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, -0.5 percentage points; 95% confidence interval [CI], -0.6 to -0.3; P<0.001). The percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter did not differ significantly between the two groups (13-week adjusted difference, 0.0 percentage points; 95% CI, -0.1 to 0.04; P<0.001 for noninferiority). The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic-pancreas group and 10.8 events per 100 participant-years in the standard-care group (P = 0.39). No episodes of diabetic ketoacidosis occurred in either group. CONCLUSIONS In this 13-week, randomized trial involving adults and children with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction than standard care in the glycated hemoglobin level