Improving the clinical value and utility of CGM systems: issues and recommendations : a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionise the use of intensive insulin therapy in diabetes; however, progress towards that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardised format for displaying results and uncertainty on how best to use CGM data to make therapeutic decisions. This scientific statement makes recommendations for systemic improvements in clinical use and regulatory (pre- and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes

Improving the clinical value and utility of CGM systems: issues and recommendations: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionize the use of intensive insulin therapy in diabetes; however, progress toward that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardized format for displaying results, and uncertainty on how best to use CGM data to make therapeutic decisions. This Scientific Statement makes recommendations for systemic improvements in clinical use and regulatory (pre- and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes

Transition from gynaecomastia to lipomastia in pubertal boys

ObjectiveGynaecomastia is frequent in pubertal boys and is regarded as a self-limiting abnormality. However, longitudinal studies proving this hypothesis are scarce.DesignLongitudinal follow-up study (median 2.4, range 1.0-4.8 years).MethodsThe regression of breast diameter was analysed in 31 pubertal boys aged 11.7-16.1 (median 13.2) years with gynaecomastia. Furthermore, weight changes (as BMI-SDS) and pubertal stage, oestradiol [E2], oestriol, oestrone, androstenedione, testosterone [T], dihydrotestosterone, gonadotropins, IGF-1, and IGFBP-3 serum concentrations determined at first clinical presentation were related to breast diameter regression determined by palpation and disappearance of breast glandular tissue in ultrasound in follow-up to identify possible predictors of breast regression.ResultsDuring the observation period, the breast diameter decreased (in median -1 (interquartile range [IQR] -5 to +1) cm). At follow-up, 6% of boys had no breast enlargement any more, and 65% developed lipomastia. Gynaecomastia was still present in 29%. None of the analysed hormones was related significantly to breast diameter regression or disappearance of breast glandular tissue. In multiple linear regression analyses adjusted for observational period, as well as age and BMI-SDS at first presentation, changes in BMI-SDS (β-coefficient 6.0 ± 2.3, p = .015) but not the E2/T ratio or any other hormone determined at baseline was related to changes in breast diameter.ConclusionsBreast diameter regression seems not to be predictable by a hormone profile in pubertal boys with gynaecomastia. In pubertal boys presenting with gynaecomastia, conversion to lipomastia of smaller volume is common. The reduction of weight status was the best predictor of breast diameter regression

Diabetes Digital App Technology: Benefits, Challenges, and Recommendations. A Consensus Report by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group

Digital health technology, especially digital and health applications ("apps"), have been developing rapidly to help people manage their diabetes. Numerous health-related apps provided on smartphones and other wireless devices are available to support people with diabetes who need to adopt either lifestyle interventions or medication adjustments in response to glucose-monitoring data. However, regulations and guidelines have not caught up with the burgeoning field to standardize how mobile health apps are reviewed and monitored for patient safety and clinical validity. The available evidence on the safety and effectiveness of mobile health apps, especially for diabetes, remains limited. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) have therefore conducted a joint review of the current landscape of available diabetes digital health technology (only stand-alone diabetes apps, as opposed to those that are integral to a regulated medical device, such as insulin pumps, continuous glucose monitoring systems, and automated insulin delivery systems) and practices of regulatory authorities and organizations. We found that, across the U.S. and Europe, mobile apps intended to manage health and wellness are largely unregulated unless they meet the definition of medical devices for therapeutic and/or diagnostic purposes. International organizations, including the International Medical Device Regulators Forum and the World Health Organization, have made strides in classifying different types of digital health technology and integrating digital health technology into the field of medical devices. As the diabetes digital health field continues to develop and become more fully integrated into everyday life, we wish to ensure that it is based on the best evidence for safety and efficacy. As a result, we bring to light several issues that the diabetes community, including regulatory authorities, policy makers, professional organizations, researchers, people with diabetes, and health care professionals, needs to address to ensure that diabetes health technology can meet its full potential. These issues range from inadequate evidence on app accuracy and clinical validity to lack of training provision, poor interoperability and standardization, and insufficient data security. We conclude with a series of recommended actions to resolve some of these shortcomings

Predictors of increasing BMI during the course of diabetes in children and adolescents with type 1 diabetes: data from the German/Austrian DPV multicentre survey

Objective: Increased weight gain has been reported prior to disease onset (accelerator hypothesis) and as a side effect of intensified insulin therapy in type 1 diabetes (T1D). Paediatric studies are complicated by the age-dependency and gender-dependency of BMI, and also by a trend towards obesity in the general population. The aim of this study was to evaluate factors related to the increase in BMI during the course of diabetes in children and adolescents with T1D in a large multicentre survey. Design: Within the DPV database (Diabetespatienten Verlaufsdokumentation) a standardised, prospective, computer-based documentation programme, data of 53 108 patients with T1D, aged <20 years, were recorded in 248 centres. 12 774 patients (53% male, mean age 13.4+/-3.9, mean diabetes duration 4.7+/-3.0 years and mean age at diabetes onset 8.7+/-4.0 years) were included in this analysis. Population-based German reference data were used to calculate BMI-SDS and define overweight and obesity. Results: 12.5% of T1D patients were overweight and 2.8% were obese. Multiple longitudinal regression analysis revealed that female gender, low BMI at diabetes onset, intensified insulin therapy and higher insulin dose, as well as pubertal diabetes onset, long diabetes duration and onset in earlier calendar years among girls, were related to higher BMI-SDS increase during the course of diabetes (p<0.01; all). Conclusions: Intensified insulin regimen is associated with weight gain during T1D treatment, in addition to demographic variables. Optimisation of diabetes management, especially in females, might limit weight gain in order to reduce overweight and obesity together with comorbidities among paediatric T1D patients

МИРГОРОДСЬКИЙ ПОЛК В РОСІЙСЬКО-ТУРЕЦЬКІЙ ВІЙНІ 1735-1739 РР.

Тема пропонованої шановному читачеві статті знаходиться на перетині воєнної історії та краєзнавства. Після тривалої неуваги, зараз воєнна історія, зокрема козаччини, розробляється досить динамічно. Варто згадати хоча б роботи І.Стороженка [1], В.Заруби [2], О.Сокирка [3], Г.Шпитальова [4]. Одночасно все ще не розроблена докладно воєнна історія полків, які складали Гетьманщину. Хоча спроби такого роду є [5], але вони зосереджені не стільки на воєнній історії, скільки на історії полку загалом і, на жаль, не представлені у вигляді монографічних досліджень та не викладені в Інтернеті, що суттєво ускладнює доступ до результатів таких досліджень. Сюжет, пов’язаний із участю Миргородського полку в російсько-турецькій війні 1735-1739 років, не знайшов висвітлення в історіографії, хоча деякі факти містять дослідження А.Байова [6], О.Апанович [7] та вже згадувана монографія Г.Шпитальова. Протягом війни Миргородський полк брав участь як у далеких виправах, так і в ближніх походах різного роду – фортифікаційних, тривожних, для планової охорони кордонів. Залучення козаків Миргородського полку до далеких походів розпочалося вже у червні 1735 р., коли всі полки (крім Стародубського та Чернігівського) вирушили до фортеці Святого Іоанна на Українській лінії, де мали збиратися для виправи на Крим. До прибуття на лінію генерального осавула Ф.Лисенка обов’язки командира цього з’єднання виконував миргородський полковник Павло Апостол [8]. Кількість козаків Миргородського полку, які вирушили в цей похід, точно невідома. Проте є дані щодо старшини, яка очолила виправу – полковник П.Апостол, суддя Ф.Остроградський, писар В.Тихонович, осавул А.Волевач, хорунжі Т.Калницький та К.Шкурка [9]. Згідно з планами Генеральної військової канцелярії (далі – ГВК) передбачалося для Кримської (1736) виправи мобілізувати 16001 гетьманця, в тому числі 1196 шабель Миргородського полку [10]. Виникли певні проблеми з залученням старшини. Наприклад, миргородський обозний С.Родзянка уперто відмовлявся від походу під приводом хвороби, в яку полковник абсолютно не вірив. Проте С.Родзянка апелював до ГВК, де знайшов підтримку. Врешті, полкова старшина миргородців у цій виправі була представлена тими ж постатями, що й 1735 р., лише осавула А.Волевача замінив його колега С.Ґалаґан [11]. За попередніми планами на 1737 р. Миргородський полк мав виставити 849 шабель у Кримський похід. Після рішення фельдмаршала Мініха залишити слобідських козаків для охорони кордону їм на заміну залучили ще 200 миргородців [12]. На цьому зміни не закінчилися. На вимогу фельдмаршала Мініха Миргородський полк перейшов у його підпорядкування і вирушив замість Кримського в Очаківський похід

A Multicenter Screening Study

Background In cystic fibrosis, highly variable glucose tolerance is suspected. However, no study provided within-patient coefficients of variation. The main objective of this short report was to evaluate within-patient variability of oral glucose tolerance. Methods In total, 4,643 standardized oral glucose tolerance tests of 1,128 cystic fibrosis patients (median age at first test: 15.5 [11.5; 21.5] years, 48.8% females) were studied. Patients included were clinically stable, non-pregnant, and had at least two oral glucose tolerance tests, with no prior lung transplantation or systemic steroid therapy. Transition frequency from any one test to the subsequent test was analyzed and within-patient coefficients of variation were calculated for fasting and two hour blood glucose values. All statistical analysis was implemented with SAS 9.4. Results A diabetic glucose tolerance was confirmed in 41.2% by the subsequent test. A regression to normal glucose tolerance at the subsequent test was observed in 21.7% and to impaired fasting glucose, impaired glucose tolerance or both in 15.2%, 12.0% or 9.9%. The average within-patient coefficient of variation for fasting blood glucose was 11.1% and for two hour blood glucose 25.3%. Conclusion In the cystic fibrosis patients studied, a highly variable glucose tolerance was observed. Compared to the general population, variability of two hour blood glucose was 1.5 to 1.8-fold higher

Psychological care in children and adolescents with type 1 diabetes in a real‐world setting and associations with metabolic control

Background: International guidelines recommend psychosocial care for children and adolescents with type 1 diabetes. Objective: To assess psychological care in children and adolescents with type 1 diabetes in a real-world setting and to evaluate associations with metabolic outcome. Methods: Delivery of psychological care, HbA1c, and rates of severe hypoglycemia and diabetic ketoacidosis (DKA) in children and adolescents with type 1 diabetes from 199 diabetes care centers participating in the German diabetes survey (DPV) were analyzed. Results: Overall, 12 326 out of 31 861 children with type 1 diabetes were supported by short-term or continued psychological care (CPC). Children with psychological care had higher HbA1c (8.0% vs 7.7%, P<.001) and higher rates of DKA (0.032 vs 0.021 per patient-year, P<.001) compared with children without psychological care. In age-, sex-, diabetes duration-, and migratory background-matched children, HbA1c stayed stable in children supported by CPC during follow-up (HbA1c 8.5% one year before psychological care started vs 8.4% after two years, P = 1.0), whereas HbA1c was lower but increased significantly by 0.3% in children without psychological care (HbA1c 7.5% vs 7.8% after two years, P <.001). Additional HbA1c-matching showed that the change in HbA1c during follow-up was not different between the groups, but the percentage of children with severe hypoglycemia decreased from 16.3% to 10.7% in children receiving CPC compared with children without psychological care (5.5% to 5.8%, P =.009). Conclusions: In this real-world setting, psychological care was provided to children with higher HbA1c levels. CPC was associated with stable glycemic control and less frequent severe hypoglycemia during follow-up

Incidence, prevalence and care of type 1 diabetes in children and adolescents in Germany: Time trends and regional socioeconomic situation

Background: Trends over time and possible socio-spatial inequalities in the incidence and care of type 1 diabetes mellitus (T1D) in children and adolescents are important parameters for the planning of target-specific treatment structures. Methodology: The incidence and prevalence of type 1 diabetes, diabetic ketoacidosis and severe hypoglycaemia as well as the HbA1c value are presented for under 18-year-olds based on data from the nationwide Diabetes Prospective Follow-up Registry (DPV) and the diabetes registry of North Rhine-Westphalia. Indicators were mapped by sex over time between 2014 and 2020, and stratified by sex, age and regional socioeconomic deprivation for 2020. Results: In 2020, the incidence was 29.2 per 100,000 person-years and the prevalence was 235.5 per 100,000 persons, with the figures being higher in boys than in girls in either case. The median HbA1c value was 7.5%. Ketoacidosis manifested in 3.4% of treated children and adolescents, significantly more often in regions with very high (4.5%) deprivation than in regions with very low deprivation (2.4%). The proportion of severe hypoglycaemia cases was 3.0%. Between 2014 and 2020, the incidence, prevalence and HbA1c levels changed little, while the proportions of ketoacidosis and severe hypoglycaemia decreased. Conclusions: The decrease in acute complications indicates that type 1 diabetes care has improved. Similar to previous studies, the results suggest an inequality in care by regional socioeconomic situation