The effect of bolus advisors on glycaemic parameters in adults with diabetes on intensive insulin therapy: A systematic review with meta-analysis.

AIM: To conduct a systematic review with meta-analysis to provide a comprehensive synthesis of randomized controlled trials (RCTs) and prospective cohort studies investigating the effects of currently available bolus advisors on glycaemic parameters in adults with diabetes. MATERIALS AND METHODS: An electronic search of PubMed, Embase, CINAHL, Cochrane Library and ClinicalTrials.gov was conducted in December 2022. The risk of bias was assessed using the revised Cochrane Risk of Bias tool. (Standardized) mean difference (MD) was selected to determine the difference in continuous outcomes between the groups. A random-effects model meta-analysis and meta-regression were performed. This systematic review was registered on PROSPERO (CRD42022374588). RESULTS: A total of 18 RCTs involving 1645 adults (50% females) with a median glycated haemoglobin (HbA1c) concentration of 8.45% (7.95%-9.30%) were included. The majority of participants had type 1 diabetes (N = 1510, 92%) and were on multiple daily injections (N = 1173, 71%). Twelve of the 18 trials had low risk of bias. The meta-analysis of 10 studies with available data on HbA1c showed that the use of a bolus advisor modestly reduced HbA1c compared to standard treatment (MD -011%, 95% confidence interval -0.22 to -0.01; I2 = 0%). This effect was accompanied by small improvements in low blood glucose index and treatment satisfaction, but not with reductions in hypoglycaemic events or changes in other secondary outcomes. CONCLUSION: Use of a bolus advisor is associated with slightly better glucose control and treatment satisfaction in people with diabetes on intensive insulin treatment. Future studies should investigate whether personalizing bolus advisors using artificial intelligence technology can enhance these effects.

Increased prevalence of cardiovascular risk factors in children and adolescents with type 1 diabetes and hypertension: The SWEET international database.

AIMS: To investigate the prevalence of modifiable cardiovascular risk factors (CVRFs), including dyslipidaemia, obesity and high glycated haemoglobin (HbA1c) concentration, in patients with type 1 diabetes (T1D), and to evaluate their association with blood pressure (BP) categories. METHODS: We analysed 21 634 children and adolescents with T1D from the SWEET international database with office BP values assessed at a three or more visits within a year from 2010 to 2021. Participants were classified into a normotensive group, a group with elevated BP (90 to 94th percentile) or a hypertensive group (≥95th percentile), based on the median BP for the visits within the last treatment year. The prevalences of dyslipidaemia [cholesterol ≥ 5.18 mmol/L (200 mg/dL)  and/or HDL cholesterol ≤ 1.036 mmol/L (40 mg/dL)  and/or LDL cholesterol ≥ 2.59 mmol/L (100 mg/dL)], obesity (body mass index ≥2 standard deviation score) and elevated HbA1c [≥ 75 mmol/mol (9%)] were evaluated in patients within each BP group. RESULTS: Patients with hypertension/elevated BP had less favourable lipid profiles, and a higher prevalence of obesity and HbA1c ≥ 75 mmol/mol than normotensive patients. A total of 38.4% of hypertensive patients and 36.0% of those with elevated BP had one CVRF, 15.1% and 10.1%, respectively, had two CVRFs, and 2.3% and 0.8%, respectively, had three CVRFs. Patients with hypertension/elevated BP had a higher prevalence of one or more CVRFs versus normotensive patients (P < 0.001). Obesity was the CVRF most strongly related to hypertension. Girls had a higher prevalence of one or more CVRFs than boys. Similar results were found in patients aged ≥13 years with hypertension compared to those aged <13 years. CONCLUSIONS: The prevalence of modifiable CVRFs is higher in children and adolescents with T1D who have elevated BP/hypertension than in those with normotension, suggesting that they are more vulnerable to future morbidity and mortality requiring early detection and intervention.

Blood pressure measurement methodology and technology in the SWEET diabetes centers: An international SWEET database survey.

INTRODUCTION: The accuracy of blood pressure (BP) measurement is a prerequisite for the reliable diagnosis and management of hypertension. OBJECTIVES: This survey evaluated the use of office and out-of-office BP measurements and the antihypertensive pharmacological treatment in expert pediatric diabetes centers. METHODS: A questionnaire was distributed in 78 reference pediatric diabetes centers of the SWEET international consortium. The methodology, devices, indications, and interpretation of office BP measurements (OBPM), 24-hour ambulatory BP monitoring (ABPM) and home BP monitoring (HBPM), and the preference for antihypertensive drug treatment was assessed. A grading score was developed to evaluate centers for overall BP measurement performance. RESULTS: Fifty-two centers responded. The average score for OBPM methodology was 72.5%, for technology 77.5% and the overall center score was 74.75%.The majority of the centers used appropriate methodology and technology, however, there was heterogeneity among them. Manual auscultatory or automated devices specifically validated for children were used by 26/52 centers. ABPM was recommended by 35/52 centers (27/35 had health insurance coverage) and HBPM by 18/52 centers. The BP measurement methodology and devices used for ABPM and HBPM were frequently inadequate. Angiotensin converting enzyme inhibitors were the most frequently prescribed drugs for treating hypertension. CONCLUSIONS: The majority of SWEET pediatric diabetes centers use adequate methodology and devices for BP measurement. ABPM is recommended by two thirds of the centers, whereas HBPM is less widely used. Further improvement in the quality of office and out-of-office BP measurements and harmonization among centers is necessary according to current guidelines.

Home Blood Pressure Monitoring in Children and Adolescents: Systematic Review of Evidence on Clinical Utility.

PURPOSE OF REVIEW: For the accurate diagnosis and management of hypertension, out-of-office blood pressure evaluation using ambulatory (ABPM) or home monitoring (HBPM) is currently recommended. In children, there is considerable evidence on the clinical utility of ABPM, whereas the evidence on HBPM is limited. This systematic review presents (i) the benefits of HBPM in children; (ii) the evidence on normal range, diagnostic accuracy, and relationship with preclinical organ damage; and (iii) guidance for devices, monitoring schedule, and interpretation. RECENT FINDINGS: HBPM is a useful adjunct to the conventional office measurements for the evaluation of children with suspected or treated hypertension. HBPM is feasible in children and has good reproducibility, diagnostic accuracy and acceptability by users, and relatively low cost. Thus, it has greater potential for widespread and long-term use than ABPM, which is more expensive and often not available or not tolerated. Automated monitors that have been clinically validated specifically in children should be used with appropriate cuff size. HBPM for 7 days (minimum 3) with duplicate morning and evening measurements (minimum 12 readings) should be performed in children with suspected or treated hypertension before each office visit. Until more data become available, in case of diagnostic disagreement between office blood pressure and HBPM, treatment decisions should be based on ABPM. HBPM is clinically useful in children with hypertension. More research is needed on its clinical application, and more automated devices need to be clinically validated in this population.

Persistent heterogeneity in diabetes technology reimbursement for children with type 1 diabetes: The SWEET perspective.

BACKGROUND: Frequent use of modern diabetes technologies increases the chance for optimal type 1 diabetes (T1D) control. Limited reimbursement influences the access of patients with T1D to these modalities and could worsen their prognosis. We aimed to describe the situation of reimbursement for insulins, glucometers, insulin pumps (CSII) and continuous glucose monitoring (CGM) for children with T1D in European countries participating in the SWEET Project and to compare data from EU countries with data from our previous study in 2009. METHODS: The study was conducted between March 2017 and August 2017. First, we approached diabetes technology companies with a survey to map the reimbursement of insulins and diabetic devices. The data collected from these companies were then validated by members of the SWEET consortium. RESULTS: We collected data from 29 European countries, whereas all types of insulins are mostly fully covered, heterogeneity was observed regarding the reimbursement of strips for glucometers (from 90 strips/month to no limit). CSII is readily available in 20 of 29 countries. Seven countries reported significant quota issues or obstacles for CSII prescription, and two countries had no CSII reimbursement. CGM is at least partially reimbursed in 17 of 29 countries. The comparison with the 2009 study showed an increasing availability of CSII and CGM across the EU. CONCLUSIONS: Although innovative diabetes technology is available, a large proportion of children with T1D still do not benefit from it due to its limited reimbursement.

Evaluation and refinement of the PRESTARt tool for identifying 12-14 year olds at high lifetime risk of developing type 2 diabetes compared to a clinicians assessment of risk: a cross-sectional study.

BACKGROUND: Traditionally Type 2 Diabetes Mellitus (T2DM) was associated with older age, but is now being increasingly diagnosed in younger populations due to the increasing prevalence of obesity and inactivity. We aimed to evaluate whether a tool developed for community use to identify adolescents at high lifetime risk of developing T2DM agreed with a risk assessment conducted by a clinician using data collected from five European countries. We also assessed whether the tool could be simplified. METHODS: To evaluate the tool we collected data from 636 adolescents aged 12-14 years from five European countries. Each participant's data were then assessed by two clinicians independently, who judged each participant to be at either low or high risk of developing T2DM in their lifetime. This was used as the gold standard to which the tool was evaluated and refined. RESULTS: The refined tool categorised adolescents at high risk if they were overweight/obese and had at least one other risk factor (High waist circumference, family history of diabetes, parental obesity, not breast fed, high sugar intake, high screen time, low physical activity and low fruit and vegetable intake). Of those found to be at high risk by the clinicians, 93% were also deemed high risk by the tool. The specificity shows that 67% of those deemed at low risk by the clinicians were also found to be a low risk by the tool. CONCLUSIONS: We have evaluated a tool for identifying adolescents with risk factors associated with the development of T2DM in the future. Future work to externally validate the tool using prospective data including T2DM incidence is required.

Pediatric diabetes training for healthcare professionals in Europe: Time for change.

BACKGROUND: Training for healthcare professionals (HCPs) in Europe who care for children and young people (CYP) with type 1 diabetes and their families is variable depending on the country. Building on the work of SWEET (Better control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference) and using the German Certified Diabetes Educators (CDEs) curriculum, a European collaboration of pediatric diabetes experts aimed to (1) establish current core elements that should be included in a pediatric diabetes education training course and (2) create a template for a European CDE's training curriculum. METHODS: A qualitative methodology incorporating a survey questionnaire, focus group discussions, individual semi-structured interviews and workshops was employed to explore participants' experiences and opinions. HCPs-pediatric consultants, diabetes nurses, dietitians and psychologists, national and local diabetes leads, academic and education leads and children, and young people with diabetes and families took part in the study. The total number of participants equaled 186. RESULTS: A template for a European Certified Diabetes Educator Curriculum (EU-CDEC) was developed based on the themes that emerged from the participants' expertise and experiences. This provides a model for HCPs' pediatric diabetes training provision. CONCLUSIONS: There is a severe shortage of high quality, standardized training for HCPs across the majority of European countries. Lack of trained HCPs for CYP with diabetes will result in the delivery of suboptimal care and impact on health, wellbeing and clinical and psychological outcomes. The EU-CDEC template can be used to increase access to high quality training provision for all HCPs across Europe and worldwide.

Prevalence of underweight, overweight, and obesity in children and adolescents with type 1 diabetes: Data from the international SWEET registry.

OBJECTIVE: To assess the prevalence of underweight (UW), overweight (OW), and obesity in children and adolescents with type 1 diabetes (T1D). METHODS: An international cross-sectional study including 23 026 T1D children (2-18 years, duration of diabetes ≥1 year) participating in the SWEET prospective, multicenter diabetes registry. Body mass index SD score (BMI-SDS) was calculated using the World Health Organization BMI charts. Children were categorized as UW (BMI-SDS < -2SD), OW (+1SD < BMI-SDS ≤ +2SD), and obese (OB) (BMI-SDS > +2SD). Hierarchic regression models were applied with adjustment for sex, age, and duration of diabetes. RESULTS: The prevalence of UW, OW, and obesity was: 1.4%, 22.3%, and 7.3% in males and 0.6%, 27.2%, and 6.8% in females. Adjusted BMI-SDS was significantly higher in females than in males (mean ± SEM: 0.54 ± 0.05 vs 0.40 ± 0.05, P < 0.0001). In males, BMI-SDS significantly decreased by age (P < 0.0001) in the first three age categories 0.61 ± 0.06 (2 to <10 years), 0.47 ± 0.06 (10 to <13 years), 0.34 ± 0.05 (13 to <16 years). In females, BMI-SDS showed a U-shaped distribution by age (P < 0.0001): 0.54 ± 0.04 (2 to <10 years), 0.39 ± 0.04 (10 to <13 years), 0.55 ± 0.04 (13 to <16 years). BMI-SDS increased by diabetes duration (<2 years: 0.38 ± 0.05, 2 to <5 years: 0.44 ± 0.05, and ≥5 years: 0.50 ± 0.05, P < 0.0001). Treatment modality did not affect BMI-SDS. Adjusted HbA1c was significantly higher in females than in males (8.20% ± 0.10% vs 8.06% ± 0.10%, P < 0.0001). In both genders, the association between HbA1c and BMI-SDS was U-shaped with the highest HbA1c in the UW and obesity groups. CONCLUSIONS: The high rate of OW and obesity (31.8%) emphasize the need for developing further strategies to prevent and treat excess fat accumulation in T1D.

The development and implementation of the SWEET Peer Review Programme for pediatric diabetes centres.

This paper describes the background to the development, implementation, and subsequent management of a programme of peer review of Pediatric Diabetes Centres belonging to the SWEET Group The paper summarizes the overall purpose of the programme, lists the principles upon which the programme is founded, and sets out the intended outcomes of the programme Details are given of the way in which the programme is delivered and summarizes the key findings from the 16 centres reviewed to date Finally the paper highlights the feedback that has been received from those who have been reviewed and those who have acted as reviewers and discusses ways in which the programme can be further developed in the future.

A description of clinician reported diagnosis of type 2 diabetes and other non-type 1 diabetes included in a large international multicentered pediatric diabetes registry (SWEET).

BACKGROUND: Although type 1 diabetes (T1D) remains the most frequent form of diabetes in individuals aged less than 20 years at onset, other forms of diabetes are being increasingly recognized. OBJECTIVES: To describe the population of children with other forms of diabetes (non-type 1) included in the multinational SWEET (Better control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference) database for children with diabetes. METHODS: Cases entered in the SWEET database are identified by their physician as T1D, type 2 diabetes (T2D) and other types of diabetes according to the ISPAD classification. Etiologic subgroups are provided for other types of diabetes. Descriptive analyses were tabulated for age at onset, gender, daily insulin doses, and hemoglobin A1c (A1C) for each type and subtype of diabetes and when possible, values were compared. RESULTS: Of the 27 104 patients included in this report, 95.5% have T1D, 1.3% T2D, and 3.2% other forms of diabetes. The two most frequent etiologies for other forms of diabetes were maturity onset diabetes of the young (MODY) (n = 351) and cystic fibrosis-related diabetes (CFRD) (n = 193). The cause was unknown or unreported in 10% of other forms of diabetes. Compared with T1D, children with T2D and CFRD were diagnosed at an older age, took less insulin and had lower A1C (all P < .0001). CONCLUSION: In centers included in SWEET, forms of diabetes other than type 1 remain rare and at times difficult to characterize. Sharing clinical information and outcome between SWEET centers on those rare forms of diabetes has the potential to improve management and outcome.

Incretins, amylin and other gut-brain axis hormones in children with coeliac disease.

BACKGROUND: Previous research indicated that coeliac disease (CD) is associated with type 1 diabetes mellitus (T1DM). However, the gut-brain axis peptide hormones secretion has not been evaluated so far in patients with CD prior to treatment initiation or under treatment, irrespective of patients having concomitant T1DM or not. The aim of the study was therefore to evaluate these gut hormones at the preprandial levels of patients with CD before and under treatment. METHODS: Of forty-seven CD children, 12 untreated (UCD), 22 treated with gluten-free diet (TCD) and 13 treated CD with coexisting T1DM (DCD), and 18 healthy controls (HC) were enrolled. Preprandial glucagon-like-peptide-1 (GLP-1), glucose-dependent-insulinotropic-polypeptide (GIP), active amylin, acylated ghrelin (AG), leptin, pancreatic polypeptide (PP) and peptide-tyrosine-tyrosine (PYY) were determined with hormone-map-array technology. RESULTS: We found in patients with CD compared with HC that the concentration of (i) GLP-1 was reduced remarkably in all patients with CD (P = 0.008), (ii) GIP was lower in patients with UCD (P = 0.008), (iii) amylin was remarkably reduced (P < 0.01) in all patients with CD, (iv) AG was significantly decreased in patients with DCD (P < 0.01), while (v) leptin, PP and PYY were not significantly different. GIP, GLP-1 and amylin levels correlated positively with insulin concentrations (P < 0.001, P = 0.004 and P < 0.01, respectively) in all patients. Amylin and GIP levels were strongly associated with triglycerides concentrations (P < 0.001, for both peptides) in children with CD. CONCLUSIONS: Our study revealed a different secretion pattern of gut-brain axis hormones in children with CD compared with HC. The alterations in the axis were more pronounced in children with both CD and T1DM.

Primary Thyroid Diffuse Large B-cell Lymphoma in a Child with Hashimoto's Thyroiditis: A Case Report

Primary thyroid lymphoma (PTL) is a rare thyroid gland cancer, with diffuse large B-cell lymphomas (DLBCL) being extremely rare in children and adolescents. Thus, optimal therapy is debatable. We describe a rare case of thyroid DLBCL in an adolescent girl with a history of Hashimoto thyroiditis (HT), the difficulty in diagnosis and the outcome of treatment. A 12-year-old girl with a nine-year history of HT was admitted with a right-sided painless progressive swelling of the neck. Physical examination and imaging including ultrasound (US), computed tomography (CT) and positron emission tomography/CT revealed an enlarged thyroid gland with right side lymphadenopathy and no metastasis. Two fine needle aspirations were done showing suspected lymphoblastic lesions for non-Hodgkin lymphoma without precise diagnosis. US guided core needle biopsy was finally performed confirming the diagnosis of DLBCL. She was treated according to LMB 96-group B protocol with no surgical removal of thyroid. The patient responded very well to treatment and 14 months later there is no evidence of relapse or metastases. PTL is an extremely rare cause of thyroid malignancy in children. However, it should be considered in the differential diagnosis of a thyroid mass in adolescents presenting with a rapidly enlarging neck mass and a history of HT. It is a treatable condition with a good prognosis, even in aggressive histological subtypes, with no need for thyroidectomy.

Relationship between Short- and Mid-Term Glucose Variability and Blood Pressure Profile Parameters: A Scoping Review.

Background. Increased variability of glucose (GV) and blood pressure (BPV) is linked to a higher risk of macro- and microvascular complications and other hard endpoints. This scoping review aims to summarize the existing evidence regarding the association between the parameters of the blood pressure (BP) profile, especially BPV, with indices of short- and mid-term GV. Methods. A literature search was conducted in the MEDLINE/PubMed, Cochrane, Embase, Web of Science, and Wiley Online Library databases. Results. The main findings of this review are as follows: (i) 13 studies were included, mainly with small sample sizes; (ii) there was a considerable degree of heterogeneity in the characteristics of the study participants (age range, individuals with normoglycemia, type 1 or 2 diabetes, normal BP, or hypertension), as well as in the methodologies (mainly in terms of the duration of the data collection period) and variability indices examined (mean amplitude of glycemic excursions and coefficient of glucose variation most frequently reported); and (iii) the results were heterogeneous regarding the association between GV and the parameters of the BP profile. Conclusions. There is a significant lack of evidence on the association between GV and BPV. Future research implementing a standardized methodology should focus on the determinants, association, and clinical relevance of GV and BPV.

Heterogeneity in the systems of pediatric diabetes care across the European Union.

BACKGROUND: It is known that the systems of pediatric diabetes care differ across the member states of the European Union (EU). The aim of this project was to characterize some of the main differences among the national systems. METHODS: Data were collected using two questionnaires. The first one was distributed among leading centers of pediatric diabetes (one per country) with the aim of establishing an overview of the systems, national policies, quality control (QC) and financing of pediatric diabetes care. Responses were received from all 27 EU countries. The second questionnaire was widely disseminated among all 354 International Society for Pediatric and Adolescent Diabetes members with a domicile in an EU country; it included questions related to individual pediatric diabetes centers. A total of 108 datasets were collected and processed from healthcare professionals who were treating more than 29 000 children and adolescents with diabetes. Data on the reimbursement policies were verified by representatives of the pharmaceutical and medical device companies. RESULTS: The collected data reflect the situation in 2009. There was a notable heterogeneity among the systems for provision of pediatric diabetes care across the EU. Only 20/27 EU countries had a pediatric diabetes register. Nineteen countries had officially recognized centers for pediatric diabetes, but only nine of them had defined criteria for becoming such a center. A system for QC of pediatric diabetes at the national level was reported in 7/26 countries. Reimbursement for treatment varied significantly across the EU, potentially causing inequalities in access to modern technologies. CONCLUSIONS: The collected data help develop strategies toward improving equity and access to modern pediatric diabetes care across Europe.

Laser treatment for lipoatrophy in children with diabetes type 1.

Introduction: Lipoatrophy (LA) is one of the complications of insulin treatment. It has become rare thanks to insulin analogues but it can still be observed in patients with diabetes type 1(T1DM). No effective treatment exists. Herein, we report for the first time two children with T1DM and LA successfully treated with laser treatment. Clinical cases: A 6-year-old child with T1DM presented with LA 4 months post-diagnosis. He was on continuous subcutaneous insulin infusion (CSII). LA presented on body sites where insulin catheter was never inserted. He underwent different treatment options with no positive effect. Laser treatment was tried with impressive improvement. The second 9-year-old child presented with LA 5 years postdiagnosis. He changed the insulin type, the site of insulin injection, and tried topical use of sodium chromoglycate cream with partial improvement. Laser treatment was finally used with remarkable outcome. Conclusion: Insulin-induced LA is now a rare skin complication with no effective treatment up to now. Laser treatment seems to be an effective treatment option.

Lipoatrophy, a rare complication of diabetes: a single-center experience.

BACKGROUND: Lipoatrophy (LA), a rare skin complication in patients with type 1 diabetes (T1D), has decreased dramatically over the past decades due to the use of human purified insulin preparations. METHODS: We collected data from the records of T1D patients with LA. Types of insulin and insulin regimen, presence of eosinophilia, anti-insulin (IAA), anti-GAD, anti-IA2 autoantibodies, other autoimmune disorders, site of atrophy and its relationship to catheter, HbA1c at LA onset and after resolution, and different treatment modalities (i.e., change of insulin type or site, sodium cromoglycate (SCG) cream, cortisone cream or percutaneous injections, and laser treatment) were recorded. RESULTS: Thirteen out of 1200 T1D subjects (1%) presented with LA. The majority were on insulin pump using rapid-acting analogs. Twelve out of 13 patients had changed the type of insulin, and most of them had switched injection sites. Ten out of 13 patients used SCG cream and 7/10 showed complete/partial improvement. One patient used dexamethasone injection with improvement. Five patients showed self-improvement. In 3/7 patients who were receiving SCG, treatment was combined with change of insulin type (glulisine); however, in 1/3, the result should be attributed to concomitant laser treatment. In 4/7 patients, there was a clear, beneficial effect of SCG. In 1/4 with partial resolution of LA, laser treatment was used after SCG, which further improved the result. CONCLUSIONS: LA is a rare skin complication seen even today with the use of insulin analogs. SCG alone or combined with change of insulin type seems to be the most effective treatment. Laser treatment is a promising new therapy.

The Importance of Office Blood Pressure Measurement Frequency and Methodology in Evaluating the Prevalence of Hypertension in Children and Adolescents With Type 1 Diabetes: The SWEET International Database.

OBJECTIVE: The prevalence of hypertension is higher in children and adolescents with type 1 diabetes (T1D) compared with those without. This retrospective analysis of a large cohort of children and adolescents with T1D from the SWEET (Better control in Pediatric and Adolescent diabeteS: Working to crEate CEnTers of Reference) international consortium of pediatric diabetes centers aimed to 1) estimate the prevalence of elevated office blood pressure (BP) and hypertension and 2) investigate the influence of BP measurement methodology on the prevalence of hypertension. RESEARCH DESIGN AND METHODS: A total of 27,120 individuals with T1D, aged 5-18 years, were analyzed. Participants were grouped into those with BP measurements at three or more visits (n = 10,440) and fewer than 3 visits (n = 16,680) per year and stratified by age and sex. A subgroup analysis was performed on 15,742 individuals from centers providing a score indicating BP measurement accuracy. RESULTS: Among participants with BP measurement at three or more visits, the prevalence of hypertension was lower compared with those with fewer than three visits (10.8% vs. 17.5% P < 0.001), whereas elevated BP and normotension were higher (17.5% and 71.7% vs. 15.3% and 67.1%, respectively; both P < 0.001). The prevalence of hypertension and elevated BP was higher in individuals aged ≥13 years than in younger ones (P < 0.001) and in male than female participants (P < 0.001). In linear regression models, systolic and diastolic BP was independently determined by the BP measurement methodology. CONCLUSIONS: The estimated prevalence of elevated BP and hypertension in children and adolescents with T1D is ∼30% and depends on the BP measurement methodology. Less frequent BP evaluation may overestimate the prevalence of hypertension.

Adjustment of Insulin Pump Settings in Type 1 Diabetes Management: Advisor Pro Device Compared to Physicians' Recommendations.

AIMS: To compare insulin dose adjustments made by physicians to those made by an artificial intelligence-based decision support system, the Advisor Pro, in people with type 1 diabetes (T1D) using an insulin pump and self-monitoring blood glucose (SMBG). METHODS: This was a multinational, non-interventional study surveying 17 physicians from 11 countries. Each physician was asked to provide insulin dose adjustments for the settings of the pump including basal rate, carbohydrate-to-insulin ratios (CRs), and correction factors (CFs) for 15 data sets of pumps and SMBG of people with T1D (mean age 18.4 ± 4.8 years; eight females; mean glycated hemoglobin 8.2% ± 1.4% [66 ± 11mmol/mol]). The recommendations were compared among the physicians and between the physicians and the Advisor Pro. The study endpoint was the percentage of comparison points for which there was an agreement on the direction of insulin dose adjustments. RESULTS: The percentage (mean ± SD) of agreement among the physicians on the direction of insulin pump dose adjustments was 51.8% ± 9.2%, 54.2% ± 6.4%, and 49.8% ± 11.6% for the basal, CR, and CF, respectively. The automated recommendations of the Advisor Pro on the direction of insulin dose adjustments were comparable )49.5% ± 6.4%, 55.3% ± 8.7%, and 47.6% ± 14.4% for the basal rate, CR, and CF, respectively( and noninferior to those provided by physicians. The mean absolute difference in magnitude of change between physicians was 17.1% ± 13.1%, 14.6% ± 8.4%, and 23.9% ± 18.6% for the basal, CR, and CF, respectively, and comparable to the Advisor Pro 11.7% ± 9.7%, 10.1% ± 4.5%, and 25.5% ± 19.5%, respectively, significant for basal and CR. CONCLUSIONS: Considerable differences in the recommendations for changes in insulin dosing were observed among physicians. Since automated recommendations by the Advisor Pro were similar to those given by physicians, it could be considered a useful tool to manage T1D.

Comparison of Insulin Dose Adjustments Made by Artificial Intelligence-Based Decision Support Systems and by Physicians in People with Type 1 Diabetes Using Multiple Daily Injections Therapy.

Objective: Artificial intelligence-based decision support systems (DSS) need to provide decisions that are not inferior to those given by experts in the field. Recommended insulin dose adjustments on the same individual data set were compared among multinational physicians, and with recommendations made by automated Endo.Digital DSS (ED-DSS). Research Design and Methods: This was a noninterventional study surveying 20 physicians from multinational academic centers. The survey included 17 data cases of individuals with type 1 diabetes who are treated with multiple daily insulin injections. Participating physicians were asked to recommend insulin dose adjustments based on glucose and insulin data. Insulin dose adjustments recommendations were compared among physicians and with the automated ED-DSS. The primary endpoints were the percentage of comparison points for which there was agreement on the trend of insulin dose adjustments. Results: The proportion of agreement and disagreement in the direction of insulin dose adjustment among physicians was statistically noninferior to the proportion of agreement and disagreement observed between ED-DSS and physicians for basal rate, carbohydrate-to insulin ratio, and correction factor (P < 0.001 and P ≤ 0.004 for all three parameters for agreement and disagreement, respectively). The ED-DSS magnitude of insulin dose change was consistently lower than that proposed by the physicians. Conclusions: Recommendations for insulin dose adjustments made by automatization did not differ significantly from recommendations given by expert physicians regarding the direction of change. These results highlight the potential utilization of ED-DSS as a useful clinical tool to manage insulin titration and dose adjustments.

Reproducibility of Office and Out-of-Office Blood Pressure Measurements in Children: Implications for Clinical Practice and Research.

This study aimed to evaluate the reproducibility of office (OBP), ambulatory (ABP), and home blood pressure (HBP) measurements in children and adolescents, and their implications in diagnosing hypertension in clinical practice and in pediatric hypertension research. Apparently healthy children and adolescents referred for suspected hypertension were included. Measurements of 2-visit OBP, 7-day HBP, and 24-hour ABP were performed twice, 1 to 6 months apart. Reproducibility was quantified using the SD of differences between repeated measurements. The sample size of clinical trials comparing the efficacy of antihypertensive drugs using each method was calculated. Fifty-eight individuals were analyzed (mean age, 13.0±2.9 years, 60.3% boys). The reproducibility of 24-hour ABP (SD of differences 5.7/4.5 systolic/diastolic) and HBP (5.9/5.0 mm Hg) were comparable and superior to that of visit-2 OBP (9.2/7.8) and awake (6.7/5.5) or asleep ABP (7.6/6.1). As a consequence, a parallel-group comparative trial aiming to detect a difference in the effect of 2 drugs of 10 mm Hg systolic BP, would require 36 participants when using OBP measurements, 14 using 24-hour ABP, and 15 using HBP (102/34/42 respectively for detecting a 5 mm Hg difference in diastolic BP). For a crossover design trial, the corresponding sample sizes are 9/3/4 for systolic BP and 26/9/11 for diastolic, respectively. These data suggest that in children and adolescents 24-hour ABP and 7-day HBP have similar reproducibility, superior to OBP and daytime or asleep ABP. These findings have major implications in diagnosing hypertension in children in clinical practice and in designing clinical research trials in pediatric hypertension.