The Glycemia Risk Index (GRI) quantifies the risk of glycemic events by considering both hypoglycemic and hyperglycemic episodes, offering a comprehensive evaluation of glycemia. While associations between GRI and various glycometric indicators have been established in clinical trials using continuous glucose monitoring (CGM), real-world assessments, particularly with intermittent scanning CGM (isCGM), are underexplored. This study examines these associations and their clinical implications in individuals with Type 1 Diabetes (T1D).

We conducted a retrospective study involving individuals with T1D undergoing intensive insulin therapy. All participants had used isCGM for at least three months. We collected clinical, metabolic, and glycemic data and calculated the GRI, with its components for hypoglycemia (CHypo) and hyperglycemia (CHyper). We then assessed the correlation between the GRI and traditional glycemic metrics in relation to the coefficient of variation (CV).

The study included 194 patients (105 males, 89 females) with a median age of 21.5 years for adults and 16 years for adolescents. Of these, 62.4% were on multiple daily injections, and 37.6% used insulin pumps. GRI showed a significant negative correlation with Time in Range (%TIR70 - 180) (p  < 0.001) and a positive association with various glycemic measures such as glycemic variability (r = 0.33, p < 0.001). Individuals with lower glycemic variability (CV< 36%) had significantly higher %TIR70 - 180 (63% vs. 39%, p < 0.01) and lower GRI (40 vs. 45.8, p < 0.01), CHyper (20 vs. 24, p = 0.01), and CHypo (2.6 vs. 3.4, p < 0.01).

GRI correlates with key glycemic metrics, indicating its potential utility in comprehensive glycemia assessment. These findings highlight the importance of individualized treatment approaches and suggest GRI's clinical relevance in optimizing glycemic management strategies for individuals with T1D.

The online version contains supplementary material available at 10.1007/s40200-025-01569-w.

Aim: To use electronic health record (EHR) data to develop a scalable and transferrable model to predict 6-month risk for diabetic ketoacidosis (DKA)-related hospitalization or emergency care in youth with type 1 diabetes (T1D). Method: To achieve a sharable predictive model, we engineered features using EHR data mapped to the T1D Exchange Quality Improvement Collaborative's (T1DX-QI) data schema used by 60+ U.S. diabetes centers and chose a compact set of 15 features (e.g., demographics, factors related to diabetes management, etc.) to yield "explainable AI" predictions for DKA risk on a 6-month horizon. We used an ensemble of gradient-boosted, tree-based models trained on data collected from September 1, 2017 to November 1, 2022 (3097 unique patients; 24,638 clinical encounters) from a tertiary care pediatric diabetes clinic network in the Midwest USA. Results: We rank-ordered the top 10, 25, 50, and 100 highest-risk youth in an out-of-sample testing set, which yielded an average precision of 0.96, 0.81, 0.75, and 0.70, respectively. The lift of the model (relative to random selection) for the top 100 individuals is 19. The model identified average time between DKA episodes, time since the last DKA episode, and T1D duration as the top three features for predicting DKA risk. Conclusions: Our DKA risk model effectively predicts youths' relative risk of experiencing hospitalization for DKA and is readily deployable to other diabetes centers that map diabetes data to the T1DX-QI schema. This model may facilitate the development of targeted interventions for youths at the highest risk for DKA. Future work will add novel features such as device data, social determinants of health, and diabetes self-management behaviors.

Background: Type 1 diabetes (T1D) is a chronic autoimmune disorder characterized by the destruction of pancreatic β-cells, leading to absolute insulin deficiency. Despite advancements in insulin therapy and glucose monitoring, achieving optimal glycemic control remains a challenge. Emerging technologies and novel therapeutic strategies are transforming the landscape of T1D management, offering new opportunities for improved outcomes. Methods: This review synthesizes recent advancements in T1D treatment, focusing on innovations in continuous glucose monitoring (CGM), automated insulin delivery systems, smart insulin formulations, telemedicine, and artificial intelligence (AI). Additionally, we explore biomedical approaches such as stem cell therapy, gene editing, immunotherapy, gut microbiota modulation, nanomedicine-based interventions, and trace element-based therapies. Results: Advances in digital health, including CGM integration with hybrid closed-loop insulin pumps and AI-driven predictive analytics, have significantly improved real-time glucose management. AI and telemedicine have enhanced personalized diabetes care and patient engagement. Furthermore, regenerative medicine strategies, including β-cell replacement, CRISPR-based gene editing, and immunomodulatory therapies, hold potential for disease modification. Probiotics and microbiome-targeted therapies have demonstrated promising effects in maintaining metabolic homeostasis, while nanomedicine-based trace elements provide additional strategies to regulate insulin sensitivity and oxidative stress. Conclusions: The future of T1D management is shifting toward precision medicine and integrated technological solutions. While these advancements present promising therapeutic avenues, challenges such as long-term efficacy, safety, accessibility, and clinical validation must be addressed. A multidisciplinary approach, combining biomedical research, artificial intelligence, and nanotechnology, will be essential to translate these innovations into clinical practice, ultimately improving the quality of life for individuals with T1D.

The incidence of Type 1 Diabetes (T1D) in children and adolescents is increasing by 3-4% per year. Children and adolescents with T1D (CwD) should receive person-centered, specialized treatment from a multidisciplinary team to ensure appropriate care. Italy is the first to implement a countrywide T1D screening program, which will raise the need for funding for specialized pediatric care. The study aims to update the organization of the Italian Centers for pediatric diabetes care.

In 2022, members of the 59 Italian Centers following CwD were invited to complete an email survey regarding the Centers' organization, characteristics, and activities. The questionnaire included information on responders, department organization, team composition, activities, and the organizational structures: department, ambulatory care services (AC), simple operational units (UOS), simple departmental operational units (UOSd), and complex operational units (UOC).

The data collected referred to the year 2022. According to the results, 21,318 people with diabetes were treated. Of these, 19,643 subjects (92.1%) have T1D (16,672 were CwD), 387 (1,8%) have Type 2 Diabetes, and 1,288 (6,1%) have other forms of diabetes. Compared to the 2012 survey, a 13% decrease (from 68 to 59 Centers) in the number of pediatric Centers caring for CwD was observed with a parallel increase of total (+ 6.6%) and average (+ 22%) number of CwD per Center. The estimated prevalence of T1D has increased (1.4 vs. 1.7 per 1,000 CwD-2012 vs. 2022). A reduction in numbers for AC (-22%) and UOS (-35%) was observed, whereas UOSd/UOC increased by 50%. Almost 35% of the dietitians and 40% of the psychologists were not permanent members of the multidisciplinary diabetes team.

The observed decrease in the overall number of pediatric diabetes Centers, the reduction in specialized and dedicated HCPs, and the concurrent increase in the number of treated CwD in the last ten years indicate an alarming situation for pediatric diabetes treatment in Italy. Furthermore, the projected rise in CwD due to the National T1D screening program emphasizes the need for increased resources for specialized pediatric care of CwD at all stages.

Background: Skin reactions and discomfort associated with insulin infusion pumps limit user adherence. A recent histopathological study by Kalus et al. (DERMIS study) reported increased eosinophilic infiltration and imputed an inflammatory response to an allergen delivered at the catheter tip. This finding might explain the pruritus reported by pump users. As eosinophils migrate to inflammatory foci, primarily due to IL-5 and CCL11, we aimed to evaluate insulin phenolic preservative (IPP) as a potential allergen in vitro and assess tissue eosinophilic infiltration in vivo. Methods: Histopathological evaluations for eosinophil recruitment were performed over 1 week following IPP infusions in swine tissue. Additional histopathological investigations of eosinophilic infiltration were conducted using three commercial glucose sensors implanted in swine for up to 3 weeks. Results: Eosinophilic infiltration in the dermis and subcutaneous tissue was observed following saline and IPP infusion and at glucose sensor implantation at all time points examined. In vitro studies revealed IPP eosinophil cytotoxicity. However, neither CCL11 nor IL-5 was detected in any of the tested tissue cells after IPP treatment. Conclusion: These findings suggest that IPP is not the only triggering allergen, as IPP did not induce eosinophils in vitro, while glucose sensors also indicated increased eosinophilic infiltration. Therefore, factors other than IPP trigger eosinophil recruitment to insulin infusion pump sets.

Time in tight range (TITR) is a novel glycemic metric assessing normoglycemia in individuals with diabetes.

To assess the attainability of the TITR (70-140 mg/dL) target in youth with diabetes using different treatment strategies during Ramadan fasting.

This prospective study included 276 non-insulin-treated type 2 diabetes mellitus (T2DM) and 426 patients with type 1 diabetes mellitus (T1DM) who were categorized into: multiple daily injections [MDI] + intermittently scanned CGM (isCGM), sensor augmented pump (SAP) and advanced hybrid closed loop (AHCL).

At the end of Ramadan, the mean TITR was 42.3 ± 6.6 % for all T1DM patients and 63.5 ± 4.0 % in T2DM (p < 0.001). The highest TITR was in T2DM group together with T1DM on AHCL (62.3 ± 11.6 %), followed by SAP group (37.7 ± 5.7 %) and MDI + isCGM group (23.6 ± 5.9 %, p < 0.001). Hypoglycemic episodes as shown by time below range (TBR) < 70 mg/dL and TBR < 54 mg/dL were minimal during Ramadan in AHCL group in comparison to before Ramadan (2.6 ± 0.7 versus 2.9 ± 0.9 %; p = 0.061 and 0.4 ± 0.1 vs 0.5 ± 0.1 %, p = 0.561, respectively) with a lower coefficient of variation (CoV) (p < 0.001) than other T1DM participants.

At the end of Ramadan, TITR was decreased in patients with T1DM except those using AHCL who had similar levels to non-insulin-treated T2DM patients. Advanced technology has the potential for achieving tight glycemic targets, along with a reduction in CoV, without increasing hypoglycemic risk compared with other insulin treatment modalities.

Objectives: Type 1 diabetes (T1D) with its worldwide increasing incidence is one of the most serious chronic conditions of adolescence. This study aimed to assess the Palestinian adolescent diabetic patients' health-related quality of life (HRQOL) and to identify specific factors that could predict poor quality of life. We also aimed to compare adolescents' reported HRQOL to proxy reports by their parents. Methods: A cross-sectional study was carried out between November 2022 and October 2023 in the six governorates of northern West Bank/Palestine: Jenin, Nablus, Qalqilya, Salfit, Tubas, and Tulkarm. Patients who were diagnosed with T1D for over 6 months from their recruitment, aged between 10 and 18 years, were recruited from diabetes clinics of the Ministry of Health (MOH) and the Palestine Diabetes Institute (PDI). One hundred seventy adolescents and 170 parents (or guardians) completed the Pediatric Quality of Life Inventory (Peds QL) 3.2 Diabetes Module for adolescents and parents, respectively. Results: An acceptable mean of 70.6 for the total score was reported for the Peds QL 3.2 Diabetes Module. Better scores were reported for the diabetes management summary score compared to the diabetes symptom summary score. Worry and communication were the lowest and highest reported subscores, respectively. Parents reported significantly lower results than adolescents. Income, gender, and hemoglobin A1c (HbA1c) were the main predictors of HRQOL among adolescents with T1D in Palestine. Conclusions: Future national health strategies should consider income differences and try to overcome health gaps among adolescents with T1D coming from low-income families. Future research is needed to explore the political and cultural aspects and their effects on HRQOL among diabetic adolescents in Palestine.

The International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines represent a rich repository that serves as the only comprehensive set of clinical recommendations for children, adolescents, and young adults living with diabetes worldwide. This chapter builds on the 2022 ISPAD guidelines, and summarizes recent advances in the technology behind glucose monitoring, and its role in glucose-responsive integrated technology that is feasible with the use of automated insulin delivery (AID) systems in children and adolescents. The International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines represent a rich repository that serves as the only comprehensive set of clinical recommendations for children, adolescents, and young adults living with diabetes worldwide. This chapter builds on the 2022 ISPAD guidelines, and summarizes recent advances in the technology behind glucose monitoring, and its role in glucose-responsive integrated technology that is feasible with the use of automated insulin delivery (AID) systems in children and adolescents.

Immunotherapies aimed at preserving residual beta cell function in type 1 diabetes have been successful, although the effect has been limited, or raised safety concerns. Transient effects often observed may necessitate redosing to prolong the effect, although this is not always feasible or safe. Treatment with intralymphatic GAD-alum has been shown to be tolerable and safe in persons with type 1 diabetes and has shown significant efficacy to preserve C-peptide with associated clinical benefit in individuals with the human leukocyte antigen DR3DQ2 haplotype. To further explore the feasibility and advantages of redosing with intralymphatic GAD-alum, six participants who had previously received active treatment with intralymphatic GAD-alum and carried HLA DR3-DQ2 received one additional intralymphatic dose of 4 μg GAD-alum in the pilot trial DIAGNODE-B. The participants also received 2000 U/day vitamin D (Calciferol) supplementation for two months, starting one month prior to the GAD-alum injection. During the 12-month follow-up, residual beta cell function was estimated with Mixed-Meal Tolerance Tests, and clinical and immune responses were observed. C-peptide decreased minimally, and most patients showed stable HbA1c and IDAA1c. The mean % TIR increased while the mean daily insulin dose decreased at month 12 compared to the baseline. Redosing with GAD-alum seems to be safe and tolerable, and may prolong the disease modification elicited by the original GAD-alum treatment.

At present, the majority of patients with type 1 diabetes mellitus do not achieve the recommended glycemic control goals to reduce the risk of acute and chronic complications. Hybrid closed-loop systems or automated insulin infusion systems emerged as an opportunity to improve metabolic control, quality of life and reduce the psychosocial impact of type 1 diabetes. This article analyzes the evidence regarding their effectiveness and safety, the challenges they pose and best practices to optimize results when implemented in clinical practice.

This scoping review aimed to identify implementation science (IS) research in pediatric diabetes, report integration of IS theory and terminology, and offer guidance for future research.

Of 23 papers identified, 19 were published since 2017 and 21 focused on type 1 diabetes. Most involved medical evidence-based practices (EBPs; n = 15), whereas fewer focused on psychosocial (n = 7) and diabetes education (n = 2). The majority either identified barriers and facilitators of implementing an EBP (n = 11) or were implementation trials (n = 11). Fewer studies documented gaps in EBP implementation in standard care (n = 7) or development of implementation strategies (n = 1). Five papers employed IS theories and two aimed to improve equity. There is a paucity of IS research in pediatric diabetes care literature. Few papers employed IS theory, used consistent IS terminology, or described IS strategies or outcomes. Guidance for future research to improve IS research in pediatric diabetes is offered.

Children and adolescents with type 1 diabetes require frequent outpatient evaluation to assess glucose trends, modify insulin doses, and screen for comorbidities. Continuous glucose monitoring (CGM) provides a detailed glycemic control assessment. Telemedicine has been increasingly used since the COVID-19 pandemic.

To investigate CGM profile parameter improvement immediately following pediatric outpatient diabetes visits and determine if visit modality impacted these metrics, completion of screening laboratory tests, or diabetic emergency occurrence.

A dual-center retrospective review of medical records assessed the CGM metrics time in range and glucose management indicator for pediatric outpatient diabetes visits during 2021. Baseline values were compared with those at 2 and 4 weeks post visit. Rates of completion of screening laboratory tests and diabetic emergencies following visits were determined.

A total of 269 outpatient visits (41.2% telemedicine) were included. Mean time in range increased by 1.63% and 1.35% at 2 and 4 weeks post visit (P=.003 and .01, respectively). Mean glucose management indicator decreased by 0.07% and 0.06% at 2 and 4 weeks post visit (P=.003 and .02, respectively). These improvements in time in range and glucose management indicator were seen across both telemedicine visits and in-person visits without a significant difference. However, patients seen in person were 2.69 times more likely to complete screening laboratory tests (P=.03). Diabetic emergencies occurred too infrequently to analyze.

Our findings demonstrate an immediate improvement in CGM metrics following outpatient visits, regardless of modality. While statistically significant, the magnitude of these changes was small; hence, multiple visits over time would be required to achieve clinically relevant improvement. However, completion of screening laboratory tests was found to be more likely after visits occurring in person. Therefore, we suggest a hybrid approach that allows patient convenience with telemedicine but also incorporates periodic in-person assessment.

Children with type 1 diabetes and their caregivers face numerous challenges navigating the unpredictability of this complex disease. Although the burden of managing diabetes remains significant, new technology has eased some of the load and allowed children with type 1 diabetes to achieve tighter glycaemic management without fear of excess hypoglycaemia. Continuous glucose monitor use alone improves outcomes and is considered standard of care for paediatric type 1 diabetes management. Similarly, automated insulin delivery (AID) systems have proven to be safe and effective for children as young as 2 years of age. AID use improves not only blood glucose levels but also quality of life for children with type 1 diabetes and their caregivers and should be strongly considered for all youth with type 1 diabetes if available and affordable. Here, we review key data on the use of diabetes technology in the paediatric population and discuss management issues unique to children and adolescents.

Professional medical care in the case of diabetes is of utmost importance to ensure patient health, compliance, and comfort. In the past decades, the emergence of healthcare medical devices has also brought important advancements in diabetology. However, this also raised new provocations for patients and healthcare professionals as well, regarding the acceptance, use, and contentment of sensors and pumps in the everyday lives of diabetic patients. The present study aimed to bring more evidence into the possibilities and pitfalls of these medical devices by interrogating 185 diabetic patients through online questionnaires from Romania. The results revealed that the medical devices can complement traditional medical care, and pre-, post-prandial, and nighttime glycemia can be more precisely achieved. Patients have also reported that the sensors and pumps can augment their daily decision-making about glycemic control and ease their daily routine. Contrariwise, the use of these medical devices is related to comfortlessness during sleeping and physical activity. Researchers acknowledge that patients' information, education, and diabetes management, through the opinion of the patients, can augment patient-focused decision-making in the daycare of diabetic patients.

Continuous glucose monitoring (CGM) systems, including real-time CGM and intermittently scanned CGM, have revolutionized diabetes management, particularly in children and adolescents with type 1 diabetes (T1D). These systems provide detailed insights into glucose variability and detect asymptomatic and nocturnal hypoglycemia, addressing limitations of traditional self-monitoring blood glucose methods. CGM devices measure interstitial glucose concentrations constantly, enabling proactive therapeutic decisions and optimization of glycemic control through stored data analysis. CGM metrics such as time in range, time below range, and coefficient of variation are crucial for managing T1D, with emerging metrics like time in tight range and glycemia risk index showing potential for enhanced glycemic assessment. Recent advancements suggest the utility of CGM systems in monitoring the early stages of T1D and individuals with obesity complicated by pre-diabetes, highlighting its therapeutic versatility. This review discusses the current CGM systems for T1D during the pediatric age, established and emerging metrics, and future applications, emphasizing the critical role of CGM devices in improving glycemic control and clinical outcomes in children and adolescents with diabetes.

The glycemic control of children with type 1 diabetes (T1D) may be influenced by the economic status of their parents.

To investigate the association between parental economic status and blood glucose levels of children with T1D using a mobile health application.

Data from children with T1D in China's largest T1D online community, Tang-TangQuan®. Blood glucose levels were uploaded every three months and parental economic status was evaluated based on annual household income. Children were divided into three groups: Low-income (< 30000 Yuan), middle-income (30000-100000 Yuan), and high-income (> 100000 yuan) (1 Yuan = 0.145 United States Dollar approximately). Blood glucose levels were compared among the groups and associations were explored using Spearman's correlation analysis and multivariable logistic regression.

From September 2015 to August 2022, 1406 eligible children with T1D were included (779 female, 55.4%). Median age was 8.1 years (Q1-Q3: 4.6-11.6) and duration of T1D was 0.06 years (0.02-0.44). Participants were divided into three groups: Low-income (n = 320), middle-income (n = 724), and high-income (n = 362). Baseline hemoglobin A1c (HbA1c) levels were comparable among the three groups (P = 0.072). However, at month 36, the low-income group had the highest HbA1c levels (P = 0.036). Within three years after registration, glucose levels increased significantly in the low-income group but not in the middle-income and high-income groups. Parental economic status was negatively correlated with pre-dinner glucose (r = -0.272, P = 0.012). After adjustment for confounders, parental economic status remained a significant factor related to pre-dinner glucose levels (odds ratio = 13.02, 95%CI: 1.99 to 126.05, P = 0.002).

The blood glucose levels of children with T1D were negatively associated with parental economic status. It is suggested that parental economic status should be taken into consideration in the management of T1D for children.

To conduct systematic evaluation of the risk predictors of glycaemic control in children and adolescents with type 1 diabetes mellitus.

Cohort studies on risk predictors of glycaemic control in children and adolescents with type 1 diabetes were retrieved from CNKI, PubMed, Web of Science, Embase databases, etc. from the construction of the repository to 3 February 2023. Literature screening was conducted according to inclusion and exclusion criteria, then data extraction of region, sample size, age, follow-up time, risk predictors, outcome indicators, etc., and quality evaluation of The Newcastle-Ottawa Scale were conducted by two researchers while the third researcher makes decisions if there are disagreements. Finally, Revman5.4 and StataMP17 were used for meta-analysis.

A total of 29 studies were included, and the results showed that insulin pump [Weighed mean difference (WMD) = -.48, 95% CI (-.73, -.24), p < .01], high-frequency sensor monitoring, early use of insulin pumps, prospective follow-up male, white race, large body mass index-standardised scoring, conscientiousness, agreeableness of mothers, eicosapentaenoic acid, leucine and protein (p < .05) were beneficial for reducing HbA1c levels in children and adolescents with diabetes. Ketoacidosis [WMD = .39, 95% CI (.28, .50), p < .01], selective admission, higher HbA1c level at one time (p < .01), higher glutamate decarboxylase antibody at 1 month after diagnosis, lower socio-economic status, non-living with biological parents, non-two-parent family, family disorder, family history of diabetes and high carbohydrate intake (p < .05) increased HbA1c levels in children and adolescents with diabetes.

For children and adolescents with type 1 diabetes mellitus, the use of insulin pump, high-frequency sensor monitoring, prospective follow-up, good family support and reasonable diet are conducive to blood glucose control, while selective admission and DKA are not. Disease characteristics and demographic characteristics of children are closely related to subsequent blood glucose control, and the relationship between diagnosis age and blood glucose control needs to be further explored.

To evaluate, from 2013 to 2022, how HbA1c, the incidence of acute complications, and use of diabetes technology changed at the national level in Norway and how glycemic control was associated with use of diabetes technology, carbohydrate counting, or participation in a quality improvement project.

This longitudinal observational study was based on 27,214 annual registrations of 6,775 children from the Norwegian Childhood Diabetes Registry from 2013 to 2022. Individuals aged >18 years, those with diabetes other than type 1, and those without HbA1c measurements were excluded. The outcome measure was HbA1c. The predictor variables in the adjusted linear mixed-effects model were 1) the use of diabetes technology, 2) the use of carbohydrate counting for meal bolusing, and 3) whether the patient's diabetes team participated in a quality improvement project.

Mean HbA1c decreased from 8.2% (2013) to 7.2% (2021), and the proportion of youth reaching an HbA1c <7.0% increased from 13% (2013) to 43% (2022). Insulin pump use increased from 65% (2013) to 91% (2022). Continuous glucose monitoring (CGM) use increased from 34% (first recorded in 2016) to 97% (2022). Insulin pump, CGM, and carbohydrate counting were associated with lower HbA1c and higher achievement of glycemic targets. Girls had a higher mean HbA1c than boys. Mean HbA1c levels were lower in clinics that participated in a quality improvement project for the following 4 years after the project.

Diabetes technology, carbohydrate counting, and systematic quality improvement in pediatric departments led to improved glycemic control.

Diabetic retinopathy (DR) is the primary microvascular complication associated with diabetes. Evidence on DR prevalence among children in New Zealand is scarce. We examined DR rates and associated risk factors in youth with type 1 diabetes (T1D) aged <16 years receiving care from a regional diabetes service in January 2006-December 2020.

DR diagnosis followed the International Society for Pediatric and Adolescent Diabetes guidelines. The study included 646 participants; mean age (±SD) at T1D diagnosis was 7.4 ± 3.6 years, 47% were female, and 69% identified as NZ Europeans.

The initial DR screening occurred at a mean age of 12.6 ± 2.4 years and 5.2 ± 2.2 years after T1D diagnosis. At the first DR screen, 23.5% of participants (152/646) were diagnosed with DR: 69.1% (105/152) with minimal, 30.3% (46/152) with mild, and one moderate case (0.7%). Older age at diagnosis (p=0.029) and longer diabetes duration (p=0.015) were predictors of DR at first screen. Patients with at least one positive DR screen had a higher average HbA1c at their first screen (+2.6 mmol/mol; p=0.042). Overall, 55.6% (359/646) of patients had a positive DR screen, whose worst grade was mostly either minimal (58.2%) or mild (40.7%) DR, with only three moderate cases (0.8%) and one severe (0.3%). Children diagnosed with T1D before age 10 were 72% more likely to have DR than older children (p < 0.0001), and DR risk was 32% and 41% higher among Pacific children than NZ European (p=0.008) and Māori (p=0.014) children. Lastly, the only predictor of DR at discharge from paediatric services was HbA1c at the first screen (p < 0.0001).

In this regional cohort of children with T1D, there was a high rate of low-grade DR overall and at first retinal screen, with an increasing rate until transfer to adult services. Our findings underscore the importance of ongoing DR screening, reducing glycaemic levels, and supporting vulnerable high-risk groups.

Automated insulin delivery (AID) systems show great promise for improving glycemic outcomes and reducing disease burden for youth with type 1 diabetes (T1D). The current study examined youth and parent perspectives after using the insulin-only iLet Bionic Pancreas (BP) during the 13-week pivotal trial.

Parents and youth participated in focus group interviews, with questions assessing participants' experiences in a variety of settings and were grounded in the Unified Theory of Acceptance and Use of Technology. Qualitative analysis was completed by 3 authors using a hybrid thematic analysis approach.

Qualitative analysis of focus groups revealed a total of 19 sub-themes falling into 5 major themes (Diabetes Burden, Freedom and Flexibility, Daily Routine, Managing Glucose Levels, and User Experience). Participants' overall experience was positive, with decreased burden and improved freedom and flexibility. Some participants reported challenges in learning to trust the system, adjusting to the user interface, and the system learning their body.

This study adds to the growing literature on patient perspectives on using AID systems and was among the first to assess caregiver and youth experiences with the BP system over an extended period (13 weeks). Patient feedback on physical experiences with the device and experiences trusting the device to manage glucose should inform future development of technologies as well as approaches to education for patients and their families.

To assess the prevalence of cardiovascular risk factors (CVRFs) in children and adolescents with type 1 diabetes (T1D) in the International SWEET registry and the possible role of clinical variables in modifying the risk of having single or multiple CVRFs.

The study is a cross-sectional study. Cut-off points for CVRFs were fixed according to International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines and WHO parameters: LDL cholesterol (LDL-C) > 100 mg/dL; Systolic Blood Pressure (BP-SDS) > 90th percentile for sex, age, and height; BMI-SDS > 2SD for sex and age. Logistic regression models were applied to evaluate variables associated with at least 1 or 2 CVRFs among registry children and adolescents.

29,649 individuals with T1D (6-18 years, T1D ≥ 2 years) participating in the SWEET prospective multicenter diabetes registry were included. In the cohort, 41 % had one or more CVRFs, and 10 % had two or more CVRFs. Thirty-five percent of enrolled individuals had LDL-C > 100 mg/dL, 26 % had BMI-SDS > 2SD, and 17 % had Systolic BP-SDS > 90th percentile. Females had higher frequency than males of having 1 or 2 CVRFs (45.1 % vs 37.4 %, 11.8 % vs 7.8 %; p < 0.001). Multivariable logistic regression models showed that sex (female), HbA1c category (>7.0 %), and age (>10 years) were associated with a higher chance of having at least 1 or 2 CVRFs (p < 0.001).

In children and adolescents with T1D, female sex, in addition to HbA1c above 7 %, and older age (>10 years) was associated with a higher risk of having at least a CVRF (LDL-C, BMI-SDS, BP) according to internationally defined cut-offs.

Changes in physical growth, neurocognitive development, and pubertal maturation are some of the challenges to achieving blood glucose targets in children with type 1 diabetes mellitus. To optimize glycemic outcomes, a comprehensive approach is crucial to address psychosocial needs, expand the use of diabetes technology, and diminish health inequities.

Introduction: To evaluate time in tight range (TITR) 70-140 mg/dL (3.9-7.8 mmol/L), its correlation with standard continuous glucose monitoring (CGM) metrics and the clinical variables that possibly have a substantial impact on its value, in a large cohort of pediatric subjects using different treatment strategies. Materials and Methods: A total of 854 children and adolescents with type 1 diabetes were consecutively recruited in this real world, dual center, cross-sectional study. Participants were categorized into four treatment groups (multiple daily injections [MDI] + real-time CGM, MDI + intermittently scanned CGM, sensor augmented pump, and hybrid closed loop [HCL]). Demographical and clinical data, including CGM data, were collected and analyzed. Results: The overall study population exhibited an average TITR of 36.4% ± 12.8%. HCL users showed higher TITR levels compared to the other treatment groups (P < 0.001). A time in range (TIR) cut-off value of 71.9% identified subjects achieving a TITR ≥50% (area under curve [AUC] 0.98; 95% confidence interval 0.97-0.99, P < 0.001), and a strong positive correlation between these two metrics was observed (r = 0.95, P < 0.001). An increase in TIR of 1% was associated with 1.84 (R2 Nagelkerke = 0.35, P < 0.001) increased likelihood of achieving TITR ≥50%. Use of HCL systems (B = 7.78; P < 0.001), disease duration (B = -0.26, P = 0.006), coefficient of variation (B = -0.30, P = 0.004), and glycated hemoglobin (B = -8.82; P < 0.001) emerged as significant predictors of TITR levels. Conclusions: Our study highlights that most children and adolescents with type 1 diabetes present TITR levels below 50%, except those using HCL. Tailored interventions and strategies should be implemented to increase TITR.

Teplizumab, a humanized monoclonal antibody to CD3 on T cells, is approved by the Food and Drug Administration to delay the onset of clinical type 1 diabetes (stage 3) in patients 8 years of age or older with preclinical (stage 2) disease. Whether treatment with intravenous teplizumab in patients with newly diagnosed type 1 diabetes can prevent disease progression is unknown.

In this phase 3, randomized, placebo-controlled trial, we assessed β-cell preservation, clinical end points, and safety in children and adolescents who were assigned to receive teplizumab or placebo for two 12-day courses. The primary end point was the change from baseline in β-cell function, as measured by stimulated C-peptide levels at week 78. The key secondary end points were the insulin doses that were required to meet glycemic goals, glycated hemoglobin levels, time in the target glucose range, and clinically important hypoglycemic events.

Patients treated with teplizumab (217 patients) had significantly higher stimulated C-peptide levels than patients receiving placebo (111 patients) at week 78 (least-squares mean difference, 0.13 pmol per milliliter; 95% confidence interval [CI], 0.09 to 0.17; P<0.001), and 94.9% (95% CI, 89.5 to 97.6) of patients treated with teplizumab maintained a clinically meaningful peak C-peptide level of 0.2 pmol per milliliter or greater, as compared with 79.2% (95% CI, 67.7 to 87.4) of those receiving placebo. The groups did not differ significantly with regard to the key secondary end points. Adverse events occurred primarily in association with administration of teplizumab or placebo and included headache, gastrointestinal symptoms, rash, lymphopenia, and mild cytokine release syndrome.

Two 12-day courses of teplizumab in children and adolescents with newly diagnosed type 1 diabetes showed benefit with respect to the primary end point of preservation of β-cell function, but no significant differences between the groups were observed with respect to the secondary end points. (Funded by Provention Bio and Sanofi; PROTECT ClinicalTrials.gov number, NCT03875729.).

Insulin lispro 100 units/mL Jr KwikPen is the first prefilled, disposable, half-unit insulin pen that delivers 0.5-30 units in increments of 0.5 units for the treatment of patients with diabetes. This study describes the profile of patients in Spain who initiated insulin therapy with Jr KwikPen in a real-world setting.

This retrospective, observational study based on IQVIA's electronic medical records database included patients with Type 1 (T1D) or Type 2 (T2D) diabetes who initiated therapy with Jr KwikPen between May 2018 and December 2020. Sociodemographic, clinical, and treatment characteristics at treatment initiation were analysed descriptively.

A total of 416 patients were included. The main characteristics of the T1D/T2D groups (N = 326/90), respectively were as follows: female sex, 61.7%/65.6%; mean age (standard deviation [SD]), 32.5 (20.7)/55.5 (16.6) years; body mass index, 20.9 (4.2)/25.2 (4.6) kg/m2 (N = 239/77); HbA1c, 7.8 (1.7)%/8.0 (1.5)% (N = 141/64); and presence of diabetes-associated comorbidities, 27.9%/64.4%. Only 32.8% of patients with T1D were < 18 years old. Among Jr KwikPen users, 12.3% (T1D/T2D, 7.7%/28.9%) were ≥ 65 years old, 17.1% patients were newly diagnosed, and 3.8% were pregnant women. The mean (SD) total insulin dose pre-index for T1D/T2D was 43.1 (23.6) and 40.7 (21.6) UI/day, respectively. The mean (SD) insulin dose at the start of Jr KwikPen use was 26.63 (16.56) and 22.58 (13.59) UI/day for T1D/T2D, respectively. Jr KwikPen was first prescribed mainly by endocrinologists (58.7%) or paediatricians (22.6%).

The profile of patients who initiated therapy with Jr KwikPen in routine practice was broad with many patients being adults. Most of these patients had T1D, inadequate glycemic control, and multiple associated comorbidities. These results suggest that Jr KwikPen is prescribed in patients who may benefit from finer insulin dose adjustments, namely children, adolescents, adults, older individuals, or pregnant women with T1D or T2D.

The American Diabetes Association's Standards of Care in Diabetes recommends the use of diabetes technology such as continuous glucose monitoring systems and insulin pumps for people living with type 1 diabetes. Unfortunately, there are multiple barriers to uptake of these devices, including local diabetes center practices. This study aimed to examine overall change and center-to-center variation in uptake of diabetes technology across 21 pediatric centers in the T1D Exchange Quality Improvement Collaborative. It found an overall increase in diabetes technology use for most centers from 2021 to 2022 with significant variation.

The greatest change in the treatment of people living with type 1 diabetes in the last decade has been the explosion of technology assisting in all aspects of diabetes therapy, from glucose monitoring to insulin delivery and decision making. As such, the aim of our systematic review was to assess the utility of these technologies as well as identify any precision medicine-directed findings to personalize care.

Screening of 835 peer-reviewed articles was followed by systematic review of 70 of them (focusing on randomized trials and extension studies with ≥50 participants from the past 10 years).

We find that novel technologies, ranging from continuous glucose monitoring systems, insulin pumps and decision support tools to the most advanced hybrid closed loop systems, improve important measures like HbA1c, time in range, and glycemic variability, while reducing hypoglycemia risk. Several studies included person-reported outcomes, allowing assessment of the burden or benefit of the technology in the lives of those with type 1 diabetes, demonstrating positive results or, at a minimum, no increase in self-care burden compared with standard care. Important limitations of the trials to date are their small size, the scarcity of pre-planned or powered analyses in sub-populations such as children, racial/ethnic minorities, people with advanced complications, and variations in baseline glycemic levels. In addition, confounders including education with device initiation, concomitant behavioral modifications, and frequent contact with the healthcare team are rarely described in enough detail to assess their impact.

Our review highlights the potential of technology in the treatment of people living with type 1 diabetes and provides suggestions for optimization of outcomes and areas of further study for precision medicine-directed technology use in type 1 diabetes.

Evaluation of the degree of adherence to self-care among Spanish type 1 diabetes (T1DM) pediatric population lacks of a validated tool.

To cross-culturally adapt and determine the psychometric properties of the Spanish version of the Diabetes Management Questionnaire to assess the degree of adherence to self-care among children with T1DM.

Translation, back-translation, and patient suggestions, were considered to obtain the Spanish version (DMQ-Sp). A cross-sectional study was conducted with 323 children (aged 8-18 years) with T1DM and their parents to determine internal reliability, structural validity, and external validity. Responsiveness to change was analyzed through a prospective longitudinal study involving 102 newly diagnosed T1DM patients. Psychometrics were evaluated for the entire sample and stratified by age (8-12 and 13-18 years).

A total of 323 children with T1DM [49.8% female; age 13.3 ± 2.8 years; 155 aged 8-12; glycated hemoglobin (HbA1c) value 7.7 ± 1.0%] answered the Spanish final version. The internal consistency Cronbach's alpha was 0.76 and intraclass correlation coefficient 0.84. Test-retest reliability was r = 0.84 (p < 0.001). Fit index of structural validity was >0.7. External validity correlated inversely with HbA1c (r = -0.39; p < 0.001). The DMQ-Sp score increased significantly after 6 months of receiving the full therapeutic education program (TEP) (baseline 57.07 ± 10.81 vs. 6 months 78.80 ± 10.31; p < 0.001).

The DMQ-Sp is reliable, valid, and sensitive to change in a large sample of children (aged 8-18 years) with T1DM and their parents.

DMQ-Sp can be a useful tool for diabetes teams to identify adherence to different tasks and to evaluate TEPs.

Technology use, including continuous glucose monitoring (CGM) and insulin pump therapy, is associated with improved outcomes in youth with type 1 diabetes (T1D). In 2017 CGM was universally funded for youth with T1D in Australia. In contrast, pump access is primarily accessed through private health insurance, self-funding or philanthropy. The study aim was to investigate the use of diabetes technology across different socioeconomic groups in Australian youth with T1D, in the setting of two contrasting funding models.

A cross-sectional evaluation of 4957 youth with T1D aged <18 years in the national registry was performed to determine technology use. The Index of Relative Socio-Economic Disadvantage (IRSD) derived from Australian census data is an area-based measure of socioeconomic status (SES). Lower quintiles represent greater disadvantage. IRSD based on most recent postcode of residence was used as a marker of SES. A multivariable generalised linear model adjusting for age, diabetes duration, sex, remoteness classification, and location within Australia was used to determine the association between SES and device use.

CGM use was lower in IRSD quintile 1 in comparison to quintiles 2 to 5 (p<0.001) where uptake across the quintiles was similar. A higher percentage of pump use was observed in the least disadvantaged IRSD quintiles. Compared to the most disadvantaged quintile 1, pump use progressively increased by 16% (95% CI: 4% to 31%) in quintile 2, 19% (6% to 33%) in quintile 3, 35% (21% to 50%) in quintile 4 and 51% (36% to 67%) in the least disadvantaged quintile 5.

In this large national dataset, use of diabetes technologies was found to differ across socioeconomic groups. For nationally subsidised CGM, use was similar across socioeconomic groups with the exception of the most disadvantaged quintile, an important finding requiring further investigation into barriers to CGM use within a nationally subsidised model. User pays funding models for pump therapy result in lower use with socioeconomic disadvantage, highlighting inequities in this funding approach. For the full benefits of diabetes technology to be realised, equitable access to pump therapy needs to be a health policy priority.

The optimal basal and bolus insulin distribution in type 1 diabetes (T1D) is still controversial. Herein, we aimed to determine the variability of basal to total daily insulin dose according to treatment modality and diabetes technologies from the Better Control in Pediatric and Adolescent Diabetes: Working to Create Centers of Reference (SWEET) registry. Methods. The study cohort was generated by using the SWEET database. Patients with T1D for at least 2 years, aged between 2.5 and 18 years, with at least one clinic visit between June 2010 and June 2021, were included in the study. Four groups were composed according to treatment modality as follows: multiple daily injections (MDI) without continuous glucose monitoring (CGM); MDI with CGM; subcutaneous insulin infusion (CSII) without CGM; and CSII with CGM. Data of the participants were analyzed and compared for each treatment modality separately.

A total of 38,956 children and adolescents were included in the study. Of the study sample, 48.6% were female, the median (range) age was 15.2 (11.9-17.2) years, and the median diabetes duration was 6.0 (3.8-9.0) years. The distribution of treatment modality was as follows: MDI without CGM, 32.9%; MDI with CGM, 18.0%; CSII without CGM, 11.7%; and CSII with CGM, 37.3%. In unadjusted data, regardless of treatment modality, all the analyses revealed a significant association between basal dose to total daily insulin dose (BD/TDD) with male gender, younger age group, and lower HbA1c, which were all related to a decreased ratio of BD/TDD (all p < 0.05). There was no association between BD/TDD and different diabetes technologies after the age, gender, and diabetes duration were adjusted.

Herein, we showed that there was an association between lower proportions of basal to total insulin and lower hemoglobin A1c in a large cross-sectional cohort of children who had T1D. There was also an association between lower BD/TDD and younger age. There was no significant difference between BD/TDD ratios under different diabetes technologies (CGM and/or CSII).

This study aims to evaluate the determinants and clinical markers of patients at risk for severe hypoglycemia (SH) in children and adolescents with type 1 diabetes. In the EPI-GLUREDIA study, clinical parameters and continuous glucose monitoring metrics from children and adolescents with type 1 diabetes were retrospectively analyzed between July 2017 and June 2022. Their clinical parameters were collected during traditional and quarterly medical consultations according to whether they experienced severe hypoglycemia or not. Then, continuous glucose monitoring metrics were analyzed on days surrounding SH during specific periods. According to the glycemic parameters, glycemic hemoglobin and glycemic mean were significantly lower in the three months preceding a SH compared with during three normal months (p < 0.05). Moreover, the time spent in hypoglycemia(time below the range, TBR_<3.3) and its strong correlation (R = 0.9, p < 0.001) with the frequency of SH represent a sensitive and specific clinical parameter to predict SH (cut-off: 9%, sensitivity: 71%, specificity: 63%). The second finding of the GLUREDIA study is that SH is not an isolated event in the glycemic follow-up of our T1DM patients. Indeed, most of the glycemic parameters (i.e., glycemic mean, glycemic variability, frequency of hypoglycemia, and glycemic targets) vary considerably in the month preceding an SH (all p < 0.05), whereas most of these studied glycemic parameters remain stable in the absence of a severe acute complication (all p > 0.05). Furthermore, the use of ROC curves allowed us to determine for each glycemic parameter a sensitive or specific threshold capable of more accurately predicting SH. For example, a 10% increase in the frequency of hypoglycemia predicts a risk of near SH with good combination of sensitivity and specificity (sensitivity: 80%, specificity: 60%). The GLUREDIA study aimed to target clinical and glycemic parameters to predict patients at risk for SH. First, we identified TBR_<3.3 < 9% as a sensitive and specific tool to reduce the frequency of SH. In addition, SH was not an isolated event but rather it was accompanied by glycemic disturbances in the 30 days before SH.

This study aimed to provide a global insight into initiatives in type 1 diabetes care driven by the COVID-19 pandemic and associations with glycemic outcomes.

An online questionnaire regarding diabetes care before and during the pandemic was sent to all centers (n=97, 66,985 youth with type 1 diabetes) active in the SWEET registry. Eighty-two responded, and 70 (42,798 youth with type 1 diabetes) had available data (from individuals with type 1 diabetes duration >3 months, aged ≤21 years) for all 4 years from 2018 to 2021. Statistical models were adjusted, among others, for technology use.

Sixty-five centers provided telemedicine during COVID-19. Among those centers naive to telemedicine before the pandemic (n=22), four continued only face-to-face visits. Centers that transitioned partially to telemedicine (n=32) showed a steady increase in HbA1c between 2018 and 2021 (p<0.001). Those that transitioned mainly to telemedicine (n=33%) improved HbA1c in 2021 compared to 2018 (p<0.001).

Changes to models of care delivery driven by the pandemic showed significant associations with HbA1c shortly after the pandemic outbreak and 2 years of follow-up. The association appeared independent of the concomitant increase in technology use among youth with type 1 diabetes.

While continuous glucose monitors (CGMs), insulin pumps, and hybrid closed-loop (HCL) systems each improve glycemic control in type 1 diabetes, it is unclear how the use of these technologies impacts real-world pediatric care.

We found 1,455 patients aged <22 years, with type 1 diabetes duration >3 months, and who had data from a single center in between both 2016-2017 (n = 2,827) and 2020-2021 (n = 2,731). Patients were grouped by multiple daily injections or insulin pump, with or without an HCL system, and using a blood glucose monitor or CGM. Glycemic control was compared using linear mixed-effects models adjusting for age, diabetes duration, and race/ethnicity.

CGM use increased from 32.9 to 75.3%, and HCL use increased from 0.3 to 27.9%. Overall A1C decreased from 8.9 to 8.6% (P < 0.0001).

Adoption of CGM and HCL was associated with decreased A1C, suggesting promotion of these technologies may yield glycemic benefits.

Compared with high-income countries, healthcare disparities and inequities are more evident in low, lower-middle, and upper-middle-income countries with poorer housing and nutrition conditions. At least 20% of Latin America and the Caribbean are low and lower-middle-income countries. Despite the majority of the other countries being upper-middle income, the United Nations Children's Fund had classified all the regions as "less developed," with limited access to health care for the most vulnerable, the children. Latin America and the Caribbean regions represent an extensive territory with communication limitations and an unstable socio-political and economic environment. After considering the vast population affected by poverty worldwide and the long-term impact of kidney disease starting in childhood, it is crucial to better understand and analyze the multifactorial limiting conditions in accessing specialized care such as pediatric nephrology in disadvantaged areas.

Constraints in accessing basic healthcare in rural areas make it impossible to receive specialized pediatric nephrology care including dialysis and transplantation. Disturbingly, incidence and prevalence figures of acute kidney injury, chronic and end-stage kidney disease in some Latin American and the Caribbean countries are unknown, and these conditions still represent a death sentence for underprivileged populations. However, the monumental efforts of the dedicated healthcare providers and stakeholders that pioneered the actions in the past 50 years have shown remarkable progress in developing pediatric nephology services across the continent.

In this review, we compile some of the latest evidence about the care of children and adolescents with kidney conditions in Latin America and the Caribbean, along with the experiences from the field in the care of these patients facing adverse conditions. We also highlight recommendations to address inequities and disparities.

To evaluate whether a second insulin bolus, calculated with a new approach, could improve postprandial glucose (PPG) after the intake of real-life high-fat (HF) and high-protein (HP) mixed meals.

Fifteen adolescents with T1D treated with non-automated insulin pumps and CGM were enrolled. Patients received standard, HF and HP mixed meals treated with one pre-meal insulin bolus; based on differences in PPG between standard, HF and HP meals, correction boluses were calculated (30% and 60% of pre-meal bolus for HF and HP meals, respectively). Then patients received the same HF or HP meal treated with pre-meal bolus plus second insulin bolus after 3 h. Differences between postprandial variables after HF and HP meals treated with one or two insulin boluses were assessed by paired Student's t-test.

Treating HF and HP meals with two insulin boluses significantly reduced the postprandial BG-AUC (21% and 26% respectively, p < 0.05), increased %TIR (from 52.5 to 78.3% for HF meal; from 32.7 to 57.1% for HP meal; p < 0.01), and reduced mean BG and %TAR (p < 0.01), with no differences in %TBR.

The new way to calculate and administer correction boluses 3 h after HF and HP meals is effective and safe in reducing PPG and the hypoglycemia risk.

Blood glucose level prediction is a critical aspect of diabetes management. It enables individuals to make informed decisions about their insulin dosing, diet, and physical activity. This, in turn, improves their quality of life and reduces the risk of chronic and acute complications. One conundrum in developing time-series forecasting models for blood glucose level prediction is to determine an appropriate length for look-back windows. On the one hand, studying short histories foists the risk of information incompletion. On the other hand, analysing long histories might induce information redundancy due to the data shift phenomenon. Additionally, optimal lag lengths are inconsistent across individuals because of the domain shift occurrence. Therefore, in bespoke analysis, either optimal lag values should be found for each individual separately or a globally suboptimal lag value should be used for all. The former approach degenerates the analysis's congruency and imposes extra perplexity. With the latter, the fine-tunned lag is not necessarily the optimum option for all individuals. To cope with this challenge, this work suggests an interconnected lag fusion framework based on nested meta-learning analysis that improves the accuracy and precision of predictions for personalised blood glucose level forecasting. The proposed framework is leveraged to generate blood glucose prediction models for patients with type 1 diabetes by scrutinising two well-established publicly available Ohio type 1 diabetes datasets. The models developed undergo vigorous evaluation and statistical analysis from mathematical and clinical perspectives. The results achieved underpin the efficacy of the proposed method in blood glucose level time-series prediction analysis.

Objective: To explore the clinical consequences and potential root causes of insulin pump-associated adverse events (AEs) reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. Research Design and Methods: Qualitative template analysis of narrative data in a 20% stratified random sample (n = 2429) of reported AEs that occurred during the first 6 months of 2020 involving five insulin pump models marketed at that time: (1) MiniMed™ 670G, (2) MiniMed™ 630G, (3) Omnipod^®, (4) Omnipod DASH^®, and (5) t:slim X2™. Results: Of the 2429 AEs, 92% included a clinical consequence in the narrative description, with critical hyperglycemia (i.e., blood glucose [BG] >400 mg/dL; 47%) and critical hypoglycemia (i.e., BG <54 mg/dL; 24%) being the most common consequence cited. Only 50% of the AE narratives included information to support the identification of a root cause. The most cited root cause informing remarks were issues with the pump or pod reservoir/cartridge (9%), the occurrence of an obstruction of flow alarm (8%), and problems with the infusion set or site (8%). Some clinical consequences and root cause informing remarks were cited more frequently in AE narratives involving specific insulin pump models, but manufacturer variability in the amount and type of information reported may have affected these findings. Conclusions: Our findings show general themes found in insulin pump-associated AE that providers can use to raise patient awareness of potential risks associated with insulin pump use and develop strategies to prevent future AEs. Improvements in AE investigation and reporting processes are still necessary.

Hypoglycemia in people with diabetes is common, especially in those taking medications such as insulin and sulfonylureas (SU) that place them at higher risk. Hypoglycemia is associated with distress in those with diabetes and their families, medication nonadherence, and disruption of life and work, and it leads to costly emergency department visits and hospitalizations, morbidity, and mortality.

To review and update the diabetes-specific parts of the 2009 Evaluation and Management of Adult Hypoglycemic Disorders: Endocrine Society Clinical Practice Guideline and to address developing issues surrounding hypoglycemia in both adults and children living with diabetes. The overriding objectives are to reduce and prevent hypoglycemia.

A multidisciplinary panel of clinician experts, together with a patient representative, and methodologists with expertise in evidence synthesis and guideline development, identified and prioritized 10 clinical questions related to hypoglycemia in people living with diabetes. Systematic reviews were conducted to address all the questions. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology was used to assess the certainty of evidence and make recommendations.

The panel agreed on 10 questions specific to hypoglycemia risk and prevention in people with diabetes for which 10 recommendations were made. The guideline includes conditional recommendations for use of real-time continuous glucose monitoring (CGM) and algorithm-driven insulin pumps in people with type 1 diabetes (T1D), use of CGM for outpatients with type 2 diabetes at high risk for hypoglycemia, use of long-acting and rapid-acting insulin analogs, and initiation of and continuation of CGM for select inpatient populations at high risk for hypoglycemia. Strong recommendations were made for structured diabetes education programs for those at high risk for hypoglycemia, use of glucagon preparations that do not require reconstitution vs those that do for managing severe outpatient hypoglycemia for adults and children, use of real-time CGM for individuals with T1D receiving multiple daily injections, and the use of inpatient glycemic management programs leveraging electronic health record data to reduce the risk of hypoglycemia.

The recommendations are based on the consideration of critical outcomes as well as implementation factors such as feasibility and values and preferences of people with diabetes. These recommendations can be used to inform clinical practice and health care system improvement for this important complication for people living with diabetes.