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Background Hybrid Closed Loop (HCL) systems aid individuals with type 1 diabetes in improving glycemic control, however, sustained use over time has not been consistent for all users. This study developed and validated prognostic models for successful 12-month use of the first commercial HCL system based on baseline and 1-month or 3-month data. Methods and materials Data from participants at the Barbara Davis Center (N=85) who began use of the MiniMed 670G HCL were used to develop prognostic models using logistic regression and Lasso model selection. Candidate factors included sex, age, duration of diabetes, baseline HbA1c, race, ethnicity, insurance status, history of insulin pump and continuous glucose monitor use, 1-month or 3-month Auto Mode use, boluses per day, and time in range (70-180 mg/dL; TIR), and scores on behavioral questionnaires. Successful use of HCL was predefined as Auto Mode use ≥60%. The 3-month model was then externally validated against a sample from Stanford University (N=55). Results Factors in the final model included baseline HbA1c, sex, ethnicity, 1-month or 3-month Auto Mode use, Boluses per Day, and TIR. The 1-month and 3-month prognostic models had very good predictive ability with area under the curve values of 0.894 and 0.900, respectively. External validity was acceptable with an area under the curve of 0.717. Conclusions Our prognostic models use clinically accessible baseline and early device-use factors to identify risk for failure to succeed with 670G HCL technology. These models may be useful to develop targeted interventions to promote success with new technologies.

ContextEarly initiation of continuous glucose monitoring (CGM) is advocated for youth with type 1 diabetes (T1D). Data to guide CGM use on time-in-range (TIR), hypoglycemia, and the role of partial clinical remission (PCR) are limited.ObjectiveOur aims were to assess whether 1) an association between increased TIR and hypoglycemia exists, and 2) how time in hypoglycemia varies by PCR status.MethodsWe analyzed 80 youth who were started on CGM shortly after T1D diagnosis and were followed for up to 1-year post diagnosis. TIR and hypoglycemia rates were determined by CGM data and retrospectively analyzed. PCR was defined as (visit glycated hemoglobin A1c) + (4*units/kg/day) less than 9.ResultsYouth were started on CGM 8.0 (interquartile range, 6.0-13.0) days post diagnosis. Time spent at less than 70 mg/dL remained low despite changes in TIR (highest TIR 74.6 ± 16.7%, 2.4 ± 2.4% hypoglycemia at 1 month post diagnosis; lowest TIR 61.3 ± 20.3%, 2.1 ± 2.7% hypoglycemia at 12 months post diagnosis). No events of severe hypoglycemia occurred. Hypoglycemia was rare and there was minimal difference for PCR vs non-PCR youth (54-70 mg/dL: 1.8% vs 1.2%, P = .04; ConclusionAs TIR gradually decreased over 12 months post diagnosis, hypoglycemia was limited with no episodes of severe hypoglycemia. Hypoglycemia rates did not vary in a clinically meaningful manner by PCR status. With CGM being started earlier, consideration needs to be given to modifying CGM hypoglycemia education, including alarm settings. These data support a trial in the year post diagnosis to determine alarm thresholds for youth who wear CGM.

OBJECTIVE Disparities in type 1 diabetes related to use of technologies like continuous glucose monitors (CGMs) and utilization of diabetes care are pronounced based on socioeconomic status (SES), race, and ethnicity. However, systematic reports of perspectives from patients in vulnerable communities regarding barriers are limited. RESEARCH DESIGN AND METHODS To better understand barriers, focus groups were conducted in Florida and California with adults ≥18 years old with type 1 diabetes with selection criteria including hospitalization for diabetic ketoacidosis, HbA1c >9%, and/or receiving care at a Federally Qualified Health Center. Sixteen focus groups were conducted in English or Spanish with 86 adults (mean age 42 ± 16.2 years). Transcript themes and pre–focus group demographic survey data were analyzed. In order of frequency, barriers to diabetes technology and endocrinology care included 1) provider level (negative provider encounters), 2) system level (financial coverage), and 3) individual level (preferences). RESULTS Over 50% of participants had not seen an endocrinologist in the past year or were only seen once including during hospital visits. In Florida, there was less technology use overall (38% used CGMs in FL and 63% in CA; 43% used pumps in FL and 69% in CA) and significant differences in pump use by SES (P = 0.02 in FL; P = 0.08 in CA) and race/ethnicity (P = 0.01 in FL; P = 0.80 in CA). In California, there were significant differences in CGM use by race/ethnicity (P = 0.05 in CA; P = 0.56 in FL) and education level (P = 0.02 in CA; P = 0.90 in FL). CONCLUSIONS These findings provide novel insights into the experiences of vulnerable communities and demonstrate the need for multilevel interventions aimed at offsetting disparities in diabetes.

Background: Diabetes technology use is associated with favorable type 1 diabetes (T1D) outcomes. American youth with public insurance, a proxy for low socioeconomic status, use less diabetes technology than those with private insurance. We aimed to evaluate the role of insurance-mediated provider implicit bias, defined as the systematic discrimination of youth with public insurance, on diabetes technology recommendations for youth with T1D in the United States. Methods: Multi-disciplinary pediatric diabetes providers completed a bias assessment comprised of a clinical vignette and ranking exercises ( n = 39). Provider bias was defined as providers: (1) recommending more technology for those on private insurance versus public insurance or (2) ranking insurance in the top 2 of 7 reasons to offer technology. Bias and provider characteristics were analyzed with descriptive statistics, group comparisons, and multivariate logistic regression. Results: The majority of providers [44.1 ± 10.0 years old, 83% female, 79% non-Hispanic white, 49% physician, 12.2 ± 10.0 practice-years] demonstrated bias ( n = 33/39, 84.6%). Compared to the group without bias, the group with bias had practiced longer (13.4±10.4 years vs 5.7 ± 3.6 years, P = .003) but otherwise had similar characteristics including age (44.4 ± 10.2 vs 42.6 ± 10.1, p = 0.701). In the logistic regression, practice-years remained significant (OR = 1.47, 95% CI [1.02,2.13]; P = .007) when age, sex, race/ethnicity, provider role, percent public insurance served, and workplace location were included. Conclusions: Provider bias to recommend technology based on insurance was common in our cohort and increased with years in practice. There are likely many reasons for this finding, including healthcare system drivers, yet as gatekeepers to diabetes technology, providers may be contributing to inequities in pediatric T1D in the United States.

The American Diabetes Association 2020 Standards of Medical Care in Diabetes (Standards of Care) recommends a hemoglobin A1c (A1C) of

Guidelines for safe exercise strategies exist for both pediatric and adult patients living with type 1 diabetes. The management of type 1 diabetes during exercise is complex, but making insulin dosing adjustments in advance of activity can yield positive outcomes and reduce the likelihood of hypoglycemia. Closed loop (also known as automated insulin delivery) systems are able to partially automate insulin delivery and can assist in exercise and overall management of type 1 diabetes. Current exercise guidelines, however, focus primarily on management strategies for patients using multiple daily injections or open loop insulin pump therapy. Closed loop systems require strategic approaches to type 1 diabetes management, including appropriate timing and duration of exercise targets and carbohydrates around exercise that have yet to be standardized. This review aims to showcase how closed loop technology has evolved over the last decade and summarizes a number of closed loop and exercise studies both in free-living conditions and clinical trials. This review also highlights strategies and approaches for exercise and type 1 diabetes management using closed loop systems. Some differences in closed loop strategies for exercise include the importance of pump suspension if disconnecting during exercise, fewer grams of uncovered carbohydrates before exercise and these should be taken close to exercise onset to avoid a rise in automated insulin delivery. A primary goal for future closed loop systems is to detect exercise without user input, so that patients are not required to preset exercise targets well in advance of activity, as are the current recommendations.

PURPOSE OF REVIEW: This review highlights challenges associated with weight management in children and adolescents with type 1 diabetes (T1D). Our purpose is to propose potential solutions to improve weight outcomes in youth with T1D. RECENT FINDINGS: A common barrier to weight management in T1D is reluctance to engage in exercise for fear of hypoglycemia. Healthcare practitioners generally provide limited guidance for insulin dosing and carbohydrate modifications to maintain stable glycemia during exercise. Adherence to dietary guidelines is associated with improved glycemia; however, youth struggle to meet recommendations. When psychosocial factors are addressed in combination with glucose trends, this often leads to successful T1D management. Newer medications also hold promise to potentially aid in glycemia and weight management, but further research is necessary. SUMMARY: Properly addressing physical activity, nutrition, pharmacotherapy, and psychosocial factors while emphasizing weight management may reduce the likelihood of obesity development and its perpetuation in this population.

The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) worldwide pandemic has been devastating particularly for older adults and those from vulnerable groups, including racial and ethnic minority populations. Additionally, people with certain underlying medical conditions, including diabetes, are also at increased risk of severe illness from coronavirus disease 2019 (COVID-19) (1,2). Some children experience significant disease (3), and pediatric deaths have been reported (4). Because “diabetes” (generally grouping together type 1 diabetes and type 2 diabetes) and chronically elevated hyperglycemia have been associated with worse outcomes in adults with COVID-19 (5), the pediatric community has voiced great concerns about risk and outcomes for children with diabetes. A foundation of pediatrics is caution about the extrapolation of adult practice to children. Many publications report poor outcomes from COVID-19 and diabetes without emphasizing that data reported are from adults, frequently older adults with additional comorbidities. Moreover, there have been warnings related to COVID-19 and immunosuppression leading to confusion, predominately outside the medical community, about the difference between immunocompromised and autoimmune. In sum, these worries have led to increases in frequency and severity of diabetic ketoacidosis (DKA), due in part to families being reluctant to enter health care settings, especially in areas where COVID-19 cases cluster (6,7). Data scarcity regarding many aspects of how COVID-19 is affecting children with both new-onset and established diabetes has magnified these concerns. In this issue of Diabetes Care , Rabbone et al. (8) describe cross-sectional data from Italy, an early pandemic epicenter. This team examined diabetes diagnoses as well as reports of DKA and SARS-CoV-2 infection in children with new-onset and established type 1 diabetes from 20 February to 14 April 2020. They compare data on new presentations and DKA rates to data from the same period in 2019. They report …

Lack of access to subspecialty care and persistent suboptimal outcomes for insulin-requiring patients with diabetes mandates development of innovative health care delivery models. The workforce shortage of endocrinologists in the United States results in primary care providers taking on the role of diabetes specialists despite lack of confidence and knowledge in complex diabetes management. The telementoring model Project ECHO amplifies and democratizes specialty knowledge to reduce disparities in care and improve health outcomes. Project ECHO can be applied to type 1 diabetes and other complex medical conditions to address health disparities and urgent needs of complex patients throughout the lifespan.

BACKGROUND: Higher serum urate levels are associated with an increased risk of diabetic kidney disease. Lowering of the serum urate level with allopurinol may slow the decrease in the glomerular filtration rate (GFR) in persons with type 1 diabetes and early-to-moderate diabetic kidney disease. METHODS: In a double-blind trial, we randomly assigned participants with type 1 diabetes, a serum urate level of at least 4.5 mg per deciliter, an estimated GFR of 40.0 to 99.9 ml per minute per 1.73 m(2) of body-surface area, and evidence of diabetic kidney disease to receive allopurinol or placebo. The primary outcome was the baseline-adjusted GFR, as measured with iohexol, after 3 years plus a 2-month washout period. Secondary outcomes included the decrease in the iohexol-based GFR per year and the urinary albumin excretion rate after washout. Safety was also assessed. RESULTS: A total of 267 patients were assigned to receive allopurinol and 263 to receive placebo. The mean age was 51.1 years, the mean duration of diabetes 34.6 years, and the mean glycated hemoglobin level 8.2%. The mean baseline iohexol-based GFR was 68.7 ml per minute per 1.73 m(2) in the allopurinol group and 67.3 ml per minute per 1.73 m(2) in the placebo group. During the intervention period, the mean serum urate level decreased from 6.1 to 3.9 mg per deciliter with allopurinol and remained at 6.1 mg per deciliter with placebo. After washout, the between-group difference in the mean iohexol-based GFR was 0.001 ml per minute per 1.73 m(2) (95% confidence interval [CI], −1.9 to 1.9; P= 0.99). The mean decrease in the iohexol-based GFR was −3.0 ml per minute per 1.73 m(2) per year with allopurinol and −2.5 ml per minute per 1.73 m(2) per year with placebo (between-group difference, −0.6 ml per minute per 1.73 m(2) per year; 95% CI, −1.5 to 0.4). The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo. The frequency of serious adverse events was similar in the two groups. CONCLUSIONS: We found no evidence of clinically meaningful benefits of serum urate reduction with allopurinol on kidney outcomes among patients with type 1 diabetes and early-to-moderate diabetic kidney disease. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; PERL ClinicalTrials.gov number, NCT02017171.)

AIM To examine the control of cardiovascular risk factors in type 1 diabetes (T1D) registries from the United States and Germany/Austria. MATERIALS AND METHODS Data on individuals aged ≥12 years with T1D for ≥1 year, from the T1D Exchange Clinic Network (T1DX, United States) and the Prospective Diabetes Follow-up Registry (DPV, Germany/Austria) from 1 January 2016 to 31 March 2018 were analysed. Linear and logistic regression models adjusted for age groups, sex, duration of diabetes and minority status were used to compare clinical characteristics and achievement of diabetes management targets between registries. RESULTS The cohort consisted of 47 936 patients (T1DX, n = 19 442; DPV, n = 28 494). Achievement of HbA1c goals (

Treatment of patients with diabetes with insulin and pramlintide (an amylin analogue) is more effective than treatment with insulin only. However, because mixtures of insulin and pramlintide are unstable and have to be injected separately, amylin analogues are only used by 1.5% of people with diabetes needing rapid-acting insulin. Here, we show that the supramolecular modification of insulin and pramlintide with cucurbit[7]uril-conjugated polyethylene glycol improves the pharmacokinetics of the dual-hormone therapy and enhances postprandial glucagon suppression in diabetic pigs. The co-formulation is stable for over 100 h at 37 °C under continuous agitation, whereas commercial formulations of insulin analogues aggregate after 10 h under similar conditions. In diabetic rats, the administration of the stabilized co-formulation increased the area-of-overlap ratio of the pharmacokinetic curves of pramlintide and insulin from 0.4 ± 0.2 to 0.7 ± 0.1 (mean ± s.d.) for the separate administration of the hormones. The co-administration of supramolecularly stabilized insulin and pramlintide better mimics the endogenous kinetics of co-secreted insulin and amylin, and holds promise as a dual-hormone replacement therapy. The co-administration of insulin and pramlintide stabilized with cucurbit[7]uril-conjugated polyethylene glycol in diabetic pigs improves the mealtime suppression of glucagon over the separate administration of the two hormones.

Context Youth with type 1 diabetes (T1D) do not meet glycated hemoglobin A1c (HbA1c) targets. Objective This work aimed to assess HbA1c outcomes in children with new-onset T1D enrolled in the Teamwork, Targets, Technology and Tight Control (4T) Study. Methods HbA1c levels were compared between the 4T and historical cohorts. HbA1c differences between cohorts were estimated using locally estimated scatter plot smoothing (LOESS). The change from nadir HbA1c (month 4) to 12 months post diagnosis was estimated by cohort using a piecewise mixed-effects regression model accounting for age at diagnosis, sex, ethnicity, and insurance type. We recruited 135 youth with newly diagnosed T1D at Stanford Children’s Health. Starting July 2018, all youth within the first month of T1D diagnosis were offered continuous glucose monitoring (CGM) initiation and remote CGM data review was added in March 2019. The main outcomes measure was HbA1c. Results HbA1c at 6, 9, and 12 months post diagnosis was lower in the 4T cohort than in the historic cohort (–0.54% to –0.52%, and –0.58%, respectively). Within the 4T cohort, HbA1c at 6, 9, and 12 months post diagnosis was lower in those patients with remote monitoring than those without (–0.14%, –0.18% to –0.14%, respectively). Multivariable regression analysis showed that the 4T cohort experienced a significantly lower increase in HbA1c between months 4 and 12 (P Conclusion A technology-enabled, team-based approach to intensified new-onset education involving target setting, CGM initiation, and remote data review statistically significantly decreased HbA1c in youth with T1D 12 months post diagnosis.

Aims: This study assessed hemoglobin A1c (HbA1c) across the lifespan in people with type 1 diabetes (T1D) in Germany/Austria, Sweden, and the United States between 2011 and 2017 to ascertain tempor...

AIM To compare HbA1c levels across the lifespan in people with type 1 diabetes in the USA with those in Germany/Austria, and to examine potential differences in HbA1c levels between sexes, insulin delivery methods and minority status. METHODS Data were extracted from the US T1D Exchange Registry (n=18 381 participants from 73 sites) and from the German/Austrian Prospective Diabetes Follow-up Registry, the DPV (n=32 643 participants from 362 sites). Mean HbA1c was calculated for each year of age for individuals aged ≤25 years, and at 2-year age intervals for individuals aged >25 years. Curves for mean HbA1c by age were estimated using locally weighted scatterplot smoothing. HbA1c differences between registries, sexes, insulin delivery methods, and minority status were assessed by age group using multiple linear regression. RESULTS In both registries, mean HbA1c increased by ~11 mmol/mol (1.0%) between the ages of 9 and 18 years, although at quite different absolute levels: from 66 mmol/mol (8.2%) to 77 mmol/mol (9.2%) in the T1D Exchange Registry, and from 56 mmol/mol (7.3%) to 66 mmol/mol (8.2%) in the DPV. Sex differences were observed in the DPV only. In the T1D Exchange Registry, injection users had higher mean HbA1c than pump users across the lifespan, whereas in the DPV higher HbA1c levels in injection users were observed in the age groups 6 to

OBJECTIVE In September 2016, the U.S. Food and Drug Administration approved the Medtronic 670G “hybrid” closed-loop system. In Auto Mode, this system automatically controls basal insulin delivery based on continuous glucose monitoring data but requires users to enter carbohydrates and blood glucose for boluses. To track real-world experience with this first commercial closed-loop device, we prospectively followed pediatric and adult patients starting the 670G system. RESEARCH DESIGN AND METHODS This was a 1-year prospective observational study of patients with type 1 diabetes starting the 670G system between May 2017 and May 2018 in clinic. RESULTS Of the total of 84 patients who received 670G and consented, 5 never returned for follow-up, with 79 (aged 9–61 years) providing data at 1 week and 3, 6, 9, and/or 12 months after Auto Mode initiation. For the 86% (68 out of 79) with 1-week data, 99% (67 out of 68) successfully started. By 3 months, at least 28% (22 out of 79) had stopped using Auto Mode; at 6 months, 34% (27 out of 79); at 9 months, 35% (28 out of 79); and by 12 months, 33% (26 out of 79). The primary reason for continuing Auto Mode was desire for increased time in range. Reasons for discontinuation included sensor issues in 62% (16 out of 26), problems obtaining supplies in 12% (3 out of 26), hypoglycemia fear in 12% (3 out of 26), multiple daily injection preference in 8% (2 out of 26), and sports in 8% (2 out of 26). At all visits, there was a significant correlation between hemoglobin A1c (HbA1c) and Auto Mode utilization. CONCLUSIONS While Auto Mode utilization correlates with improved glycemic control, a focus on usability and human factors is necessary to ensure use of Auto Mode. Alarms and sensor calibration are a major patient concern, which future technology should alleviate.

OBJECTIVE We sought to evaluate copeptin concentrations in adolescents with and without type 1 diabetes (T1D) and examine the associations between copeptin and measures of arterial stiffness and kidney dysfunction. RESEARCH DESIGN AND METHODS This analysis included 169 adolescents with T1D (12-19 years of age, 59% girls, mean HbA1c 9.0 ± 1.5% and diabetes duration of 8.6 ± 2.9 years), in addition to 61 controls without T1D. Arterial stiffness including carotid-femoral pulse wave velocity (CF-PWV), carotid-radial PWV (CR-PWV), augmentation index normalized to heart rate of 75 bpm (AIx@HR75), and brachial artery distensibility (BAD). Serum copeptin, urinary albumin-to-creatinine ratio (UACR), and estimated glomerular filtration rate (eGFR) by serum creatinine and cystatin C were also assessed. RESULTS Compared to controls, adolescents with T1D had higher median (Q1-Q3) copeptin (7.5 [5.2-11.3] vs 6.4 [4.8-8.3] pmol/L, P = .01), mean ± SD eGFR (121 ± 23 vs 112 ± 16 mL/min/1.73m2 , P = .002) and lower BAD (7.1 ± 1.3 vs 7.2 ± 1.2%, P = .02). Adolescents with T1D in the in high tertile copeptin group (>9.1 pmol/L) had higher AIx@HR75 (10.7 ± 1.2 vs 5 ± 1.2, P = .001), CR-PWV (5.30 ± 1.0 vs 5.18 ± 1.0 m/s, P = .04), and UACR (12 ± 1 vs 8 ± 1 mg/g, P = .025) compared to those in low tertile (

Objectives Only a fraction of youth meet established targets for glycemic control; many experience deteriorating control over time. We compared trajectories of hemoglobin A1c (HbA1c) among youth from three trans-continental type 1 diabetes (T1D) registries and identified clinical variables associated with the odds of following increasing vs stable trajectories. Research design and methods Analyses included longitudinal data from 15 897 individuals age 8 to 18 with T1D for at least 2 years and HbA1c measurements in at least 5 years during the observation period. Cohorts were selected from Australasian Diabetes Data Network (ADDN; Australia), German/Austrian/Luxembourgian Diabetes-Patienten-Verlaufsdokumentation initiative (DPV; Germany/Austria/Luxembourga), and the T1D Exchange Clinic Network (T1DX; US) clinic registries. Group-based trajectory modeling and multivariable logistic regression identified unique HbA1c trajectories and their predictors. Results Five heterogeneous trajectories of glycemic control in each registry were identified: low, intermediate, high stable; intermediate and high increasing. The overall HbA1c level for each trajectory group tended to be lowest in the DPV, higher in the ADDN, and highest in the T1DX. The absolute level of HbA1c and the proportion of individuals within each trajectory varied across registries: 17% to 22% of individuals followed an increasing trajectory. Compared with maintaining a stable trajectory, following an increasing trajectory was significantly associated with ethnic minority status, lower height z-score, higher BMI z-score, insulin injection therapy, and the occurrence of severe hypoglycemia; however, these factors were not consistent across the three registries. Conclusions We report the first multinational registry-based comparison of glycemic control trajectories among youth with T1D from three continents and identify possible targets for intervention in those at risk of an increasing HbA1c trajectory.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the American Diabetes Association (ADA) Co-Sponsored the workshop, Using Patient Reported Outcomes in Diabetes Research and Practice. The goal of the workshop was to identify PRO research priorities for those living with type 1 or type 2 diabetes, discuss considerations for use of disease specific versus generic measures, as well as outline research priorities to meet key end-user needs for assessing PROs for diabetes researchers, clinicians/hospital systems, patients/caregivers, and regulators. Here, we summarize the conclusions and recommendations from the workshop.

OBJECTIVE Higher serum uric acid (SUA) is associated with diabetic kidney disease (DKD). Preventing Early Renal Loss in Diabetes (PERL) evaluates whether lowering SUA with allopurinol slows glomerular filtration rate (GFR) loss in people with type 1 diabetes (T1D) and mild to moderate DKD. We present the PERL rationale, design, and baseline characteristics. RESEARCH DESIGN AND METHODS This double-blind, placebo-controlled, multicenter trial randomized 530 participants with T1D, estimated GFR (eGFR) of 40–99.9 mL/min/1.73 m2, SUA ≥4.5 m/dL, and micro- to macroalbuminuric DKD or normoalbuminuria with declining kidney function (NDKF) (defined as historical eGFR decline ≥3 mL/min/1.73 m2/year) to allopurinol or placebo. The primary outcome is baseline-adjusted iohexol GFR (iGFR) after 3 years of treatment plus a 2-month washout period. RESULTS Participants are 66% male and 84% white. At baseline, median age was 52 years and diabetes duration was 35 years, 93% of participants had hypertension, and 90% were treated with renin-angiotensin system inhibitors (median blood pressure 127/71 mmHg). Median HbA1c was 8%, SUA 5.9 mg/dL, iGFR 68 mL/min/1.73 m2, and historical eGFR slope −3.5 mL/min/1.73 m2/year. Compared with participants with albuminuria (n = 419), those with NDKF (n = 94) were significantly older (56 vs. 52 years), had lower HbA1c (7.7 vs. 8.1%) and SUA (5.4 vs. 6.0 mg/dL), and had higher eGFR (82 vs. 74 mL/min/1.73 m2) and historical eGFR loss (−4.7 vs. −2.5 mL/min/1.73 m2/year). These differences persisted when comparing groups with similar rates of historical eGFR loss. CONCLUSIONS PERL will determine the effect of allopurinol on mild to moderate DKD in T1D, with or without albuminuria. Participants with normoalbuminuria and rapid GFR loss manifested many DKD risk factors of those with albuminuria, but with less severity.

Objective: Hybrid closed-loop (HCL) artificial pancreas (AP) systems are now moving from research settings to widespread clinical use. In this study, the inControl algorithm developed by TypeZero Technologies was embedded to a commercial Tandem t:slim X2 insulin pump, now called Control-IQ, paired with a Dexcom G6 continuous glucose monitor and tested for superiority against sensor augmented pump (SAP) therapy. Both groups were physician-monitored throughout the clinical trial. Research Design and Methods: In a randomized controlled trial, 24 school-aged children (6–12 years) with type 1 diabetes (T1D) participated in a 3-day home-use trial at two sites: Stanford University and the Barbara Davis Center (50% girls, 9.6 ± 1.9 years of age, 4.5 ± 1.9 years of T1D, baseline hemoglobin A1c 7.35% ± 0.68%). Study subjects were randomized 1:1 at each site to either HCL AP therapy with the Control-IQ system or SAP therapy with remote monitoring. Results: The primary outcome, time in target range 70–180 mg/dL, using Control-IQ significantly improved (71.0% ± 6.6% vs. 52.8% ± 13.5%; P = 0.001) and mean sensor glucose (153.6 ± 13.5 vs. 180.2 ± 23.1 mg/dL; P = 0.003) without increasing hypoglycemia time

Background: Continuous glucose monitoring (CGM) can improve glycemic control for adults with type 1 diabetes (T1D) but certain barriers interfere with consistent use including cost, data overload, alarm fatigue, physical discomfort, and unwanted social attention. This pilot study aimed to examine feasibility and acceptability of a behavioral intervention, ONBOARD (Overcoming Barriers and Obstacles to Adopting Diabetes Devices) to support adults with T1D in optimizing CGM use. Methods: Adults (18–50 years) with T1D in their first year of CGM use were invited to participate in a tailored, multicomponent telehealth-based intervention delivered over four 60-min sessions every 2–3 weeks. Participants completed surveys (demographics; diabetes distress, Diabetes Distress Scale for adults with type 1 diabetes; satisfaction with program) and provided CGM data at baseline and postintervention (3 months). Data were analyzed using paired t-tests and Wilcoxon signed-rank tests. Results: Twenty-two participants (age = 30.95 ± 8.32 years; 59% women; 91% non-Hispanic; 86% White, 5% Black, 9% other; 73% pump users) completed the study. ONBOARD demonstrated acceptability and a high rate of retention. Moderate effect sizes were found for reductions in diabetes distress (P = 0.01, r = −0.37) and increases in daytime spent in target range (70–180 mg/dL: P = 0.03, r = −0.35). There were no significant increases in hypoglycemia. Conclusions: Findings show preliminary evidence of feasibility, acceptability, and efficacy of ONBOARD for supporting adults with T1D in optimizing CGM use while alleviating diabetes distress. Further research is needed to examine ONBOARD in a larger sample over a longer period.

Dual‐hormone replacement therapy with insulin and amylin in patients with type 1 diabetes has the potential to improve glucose management. Unfortunately, currently available formulations require burdensome separate injections at mealtimes and have disparate pharmacokinetics that do not mimic endogenous co‐secretion. Here, amphiphilic acrylamide copolymers are used to create a stable co‐formulation of monomeric insulin and amylin analogues (lispro and pramlintide) with synchronous pharmacokinetics and ultra‐rapid action. The co‐formulation is stable for over 16 h under stressed aging conditions, whereas commercial insulin lispro (Humalog) aggregates in 8 h. The faster pharmacokinetics of monomeric insulin in this co‐formulation result in increased insulin–pramlintide overlap of 75 ± 6% compared to only 47 ± 7% for separate injections. The co‐formulation results in similar delay in gastric emptying compared to pramlintide delivered separately. In a glucose challenge, in rats, the co‐formulation reduces deviation from baseline glucose compared to insulin only, or separate insulin and pramlintide administrations. Further, comparison of interspecies pharmacokinetics of monomeric pramlintide suggests that pharmacokinetics observed for the co‐formulation will be well preserved in future translation to humans. Together these results suggest that the co‐formulation has the potential to improve mealtime glucose management and reduce patient burden in the treatment of diabetes., Currently available dual‐hormone treatment with insulin and amylin requires burdensome separate injections at mealtimes and has disparate pharmacokinetics that do not mimic endogenous co‐secretion. Here, a stable co‐formulation of monomeric insulin and amylin analogues (lispro and pramlintide) exhibiting synchronous pharmacokinetics and ultra‐rapid action is created by leveraging amphiphilic acrylamide copolymers as excipients.

There are 150 million people with diabetes worldwide who require insulin replacement therapy, and the prevalence of diabetes is rising the fastest in middle- and low-income countries. The current formulations require costly refrigerated transport and storage to prevent loss of insulin integrity. This study shows the development of simple "drop-in" amphiphilic copolymer excipients to maintain formulation integrity, bioactivity, pharmacokinetics, and pharmacodynamics for over 6 months when subjected to severe stressed aging conditions that cause current commercial formulation to fail in under 2 weeks. Further, when these copolymers are added to Humulin R (Eli Lilly) in original commercial packaging, they prevent insulin aggregation for up to 4 days at 50 °C compared to less than 1 day for Humulin R alone. These copolymers demonstrate promise as simple formulation additives to increase the cold chain resilience of commercial insulin formulations, thereby expanding global access to these critical drugs for treatment of diabetes.

Continuous glucose monitoring (CGM) use is associated with improved A1C outcomes and quality of life in adolescents and young adults with diabetes; however, CGM uptake is low. This article reports on a quality improvement (QI) initiative of the T1D Exchange Quality Improvement Collaborative to increase CGM use among patients in this age-group. Ten centers participated in developing a key driver diagram and center-specific interventions that resulted in an increase in CGM use from 34 to 55% in adolescents and young adults over 19–22 months. Sites that performed QI tests of change and documented their interventions had the highest increases in CGM uptake, demonstrating that QI methodology and sharing of learnings can increase CGM uptake.

To slow the spread of COVID-19, a shelter in place (SIP) order was imposed in California between 03/16/2020 - 05/31/2020. We assessed the impact of SIP on glycemic control in a pediatric population with T1D using a continuous glucose monitor (CGM). We hypothesized that glucose control would improve due to increased supervision at home. The retrospective study included 96 patients between the ages of 3-22 years who were diagnosed with T1D at least one year earlier. We analyzed CGM data during three time periods: baseline, SIP, and post SIP (06/01/2020 - 07/30/2020) and compared standard CGM metrics controlling for gender (56% male), race (55% White), ethnicity (70% non-Hispanic), age (mean 11 yrs ± 3.9), and insurance type (8.4% public). The mean time in range (70-180 mg/dL: TIR) increased across the three time periods: from 59.9% ± 15.1 at baseline to 62.8% ± 15.9 during SIP (p

This pilot and feasibility study aimed to identify dietary strategies to optimize glycemic control and weight management in overweight or obese young adults with T1D. In a sequential multiple assignment randomized trial, participants were randomized to a hypocaloric low-carbohydrate (CHO; 20-25% CHO), hypocaloric moderately low fat (30% energy fat), or Mediterranean (not calorie restricted) diet, with advice to maintain usual physical activity (PA). PA data were collected in a convenience sample of participants from 06/20 to 02/21. Young adults with T1D (n=27, age 25±3 years, 78% female, A1c 7.3±1.2%, BMI 30.7±3.4) wore PA trackers for 2-week periods during diet assignments. Median (IQR) daily steps were 4,931 (3,443-7,363), 5,562 (4,191-9,931), 6,457 (4,394-9,655) for Low CHO, Look AHEAD, and Mediterranean diets, respectively and daily moderate-to-vigorous PA (MVPA) mins were 16 (4-31), 18 (5-31), and 22 (6-32), respectively. Daily steps, active time, or MVPA did not differ by diet (p>0.05). We demonstrate that in a pilot study emphasizing diet and weight loss in young adults with T1D, PA was often below the recommended target of 30 mins MVPA/day (or 150 mins/week). Thus, a larger, adaptive weight management intervention will need to incorporate diet as well as safe and effective PA strategies for overweight and obese young adults with T1D. Disclosure D. P. Zaharieva: None. D. M. Maahs: Advisory Panel; Self; Abbott Diabetes, Dompe, Eli Lilly and Company, Medtronic, Novo Nordisk, Consultant; Self; aditxt. For the act1on study: n/a. F. R. Muntis: None. N. Arrizon- ruiz: None. J. Thomas: None. E. J. Mayer-davis: None. A. Addala: None. M. A. Clements: Consultant; Self; Eli Lilly and Company, Employee; Self; Glooko, Inc., Research Support; Self; Abbott Diabetes, Dexcom, Inc. A. Kollu: None. M. Riddell: Advisory Panel; Self; Zealand Pharma A/S, Consultant; Self; Lilly Diabetes, Research Support; Self; Dexcom, Inc., Insulet Corporation, Speaker’s Bureau; Self; Novo Nordisk Inc., Sanofi, Stock/Shareholder; Self; Zucara Therapeutics Inc. Funding National Institute of Diabetes and Digestive and Kidney Diseases (1DP3DK113358)

The utility of CGM to improve glycemic control and QoL is well established; however, real-world use of CGM varies among people with T1D. The objectives of this study were to analyze the rates of CGM use and association to glycemic control (A1c) in the U.S. T1DX-QI Collaborative and the German-Austrian DPV Initiative. EMR data were analyzed for 15,113 T1DX-QI patients and 41,640 DPV patients with clinic visits in 2019. Mean age for T1DX-QI patients was 19.6 13.2 yrs, 48.7% were female, and A1c was 8.6 2.0%. Among DPV patients, mean age was 21.9 18.0 yrs, 46.9% were female, and A1c was 7.7 1.4%. Overall CGM use in T1DX-QI was 53.3% with highest rates in adults (age distribution 65 yrs: 55.7%). For DPV, overall CGM use was 56.3% with highest rates in pediatrics (age 65 yrs: 18.0%). A1c was lower in CGM users compared to non-users across all age groups in both T1DX-QI and DPV patients (Figure). In this transatlantic comparison, CGM use in patients with T1D was associated with lower A1c in both registries, but rates of CGM use varied across age groups. Quality improvement initiatives and advocacy efforts to improve health policy are needed to promote more widespread uptake of CGM worldwide. Disclosure D. Desalvo: Consultant; Self; Insulet Corporation, Research Support; Self; Insulet Corporation, Speaker9s Bureau; Self; Dexcom, Inc. R. W. Holl: None. S. Lanzinger: None. N. Noor: Research Support; Self; Dexcom, Inc. C. Steigleder-schweiger: None. O. Ebekozien: None. S. Von sengbusch: Other Relationship; Self; Abbott, Berlin-Chemie AG, Dexcom, Inc., Hexal, Infectopharm, Lilly Diabetes, Medtronic, Novo Nordisk, Sanofi-Aventis Deutschland GmbH. N. Jones: Consultant; Self; Companion Medical, Medtronic. K. Laubner: None. D. M. Maahs: Advisory Panel; Self; Abbott Diabetes, Dompe, Eli Lilly and Company, Medtronic, Novo Nordisk, Consultant; Self; aditxt. Funding The Leona M. and Harry B. Helmsley Charitable Trust

Context COVID-19 morbidity and mortality are increased in type 1 diabetes (T1D), but few data focus on age-based outcomes. Objective This work aimed to quantify the risk for COVID-19–related hospitalization and adverse outcomes by age in people with T1D. Methods For this observational, multisite, cross-sectional study of patients with T1D and laboratory-confirmed COVID-19 from 56 clinical sites in the United States, data were collected from April 2020 to March 2021. The distribution of patient factors and outcomes across age groups (0-18, 19-40, and > 40 years) was examined. Descriptive statistics were used to describe the study population, and multivariate logistic regression models were used to analyze the relationship between age, adverse outcomes, and hospitalization. The main outcome measure was hospitalization for COVID-19. Results A total of 767 patients were analyzed. Fifty-four percent (n = 415) were aged 0 to 18 years, 32% (n = 247) were aged 19 to 40 years, and 14% (n = 105) were older than 40 years. A total of 170 patients were hospitalized, and 5 patients died. Compared to the 0- to 18-years age group, those older than 40 years had an adjusted odds ratio of 4.2 (95% CI, 2.28-7.83) for hospitalization after adjustment for sex, glycated hemoglobin A1c, race, insurance type, and comorbidities. Conclusion Age older than 40 years is a risk factor for patients with T1D and COVID-19, with children and younger adults experiencing milder disease and better prognosis. This indicates a need for age-tailored treatments, immunization, and clinical management of individuals affected by T1D.

Objective To develop and scale algorithm-enabled patient prioritization to improve population-level management of type 1 diabetes (T1D) in a pediatric clinic with fixed resources, using telemedicine and remote monitoring of patients via continuous glucose monitor (CGM) data review. Research design and methods We adapted consensus glucose targets for T1D patients using CGM to identify interpretable clinical criteria to prioritize patients for weekly provider review. The criteria were constructed to manage the number of patients reviewed weekly and identify patients who most needed provider contact. We developed an interactive dashboard to display CGM data relevant for the patients prioritized for review. Results The introduction of the new criteria and interactive dashboard was associated with a 60% reduction in the mean time spent by diabetes team members who remotely and asynchronously reviewed patient data and contacted patients, from 3.2 ± 0.20 to 1.3 ± 0.24 minutes per patient per week. Given fixed resources for review, this corresponded to an estimated 147% increase in weekly clinic capacity. Patients who qualified for and received remote review (n = 58) have associated 8.8 percentage points (pp) (95% CI = 0.6-16.9 pp) greater time-in-range (70-180 mg/dL) glucoses compared to 25 control patients who did not qualify at twelve months after T1D onset. Conclusions An algorithm-enabled prioritization of T1D patients with CGM for asynchronous remote review reduced provider time spent per patient and was associated with improved time-in-range. This article is protected by copyright. All rights reserved.

ObjectiveTo develop and scale algorithm-enabled patient prioritization to improve population-level management of type 1 diabetes (T1D) in a pediatric clinic with fixed resources, using telemedicine and remote monitoring of patients via continuous glucose monitor (CGM) data review.Research Design and MethodsWe adapted consensus glucose targets for T1D patients using CGM to identify interpretable clinical criteria to prioritize patients for weekly provider review. The criteria were constructed to manage the number of patients reviewed weekly and identify patients who most needed provider contact. We developed an interactive dashboard to display CGM data relevant for the patients prioritized for review.ResultsThe introduction of the new criteria and interactive dashboard was associated with a 60% reduction in the mean time spent by diabetes team members who remotely and asynchronously reviewed patient data and contacted patients, from 3.2±0.20 to 1.3±0.24 minutes per patient per week. Given fixed resources for review, this corresponded to an estimated 147% increase in weekly clinic capacity. Patients who qualified for and received remote review (n=58) have associated 8.8 percentage points (pp) (95% CI = 0.6–16.9pp) greater time-in-range (70-180 mg/dL) glucoses compared to 25 control patients who did not qualify at twelve months after T1D onset.ConclusionsAn algorithm-enabled prioritization of T1D patients with CGM for asynchronous remote review reduced provider time spent per patient and was associated with improved time-in-range.

OBJECTIVES Distinct hemoglobin A1c (HbA1c) trajectories during puberty are identified in youth with established type 1 diabetes (T1D). We used data from 3 international registries to evaluate whether distinct HbA1c trajectories occur from T1D onset. METHODS Participants were RESULTS Five distinct trajectories occurred in all 3 registries, with similar patterns of proportions by group. More than 50% had stable HbA1c categorized as being either low stable or intermediate stable. Conversely, ∼15% in each registry were characterized by stable HbA1c >8.0% (high stable), and ∼11% had values that began at or near the target but then increased (target increase). Only ∼5% of youth were above the target from diagnosis, with an increasing HbA1c trajectory over time (high increase). This group differed from others, with higher rates of minority status and an older age at diagnosis across all 3 registries (P ≤ .001). CONCLUSIONS Similar postdiagnostic HbA1c patterns were observed across 3 international registries. Identifying the youth at the greatest risk for deterioration in HbA1c over time may allow clinicians to intervene early, and more aggressively, to avert increasing HbA1c.

Aim This study aimed to capture the experience of parents of youth with recent onset Type 1 diabetes who initiated use of continuous glucose monitoring (CGM) technology soon after diagnosis, which is a new practice. Methods Focus groups and individual interviews were conducted with parents of youth with Type 1 diabetes who had early initiation of CGM as part of a new clinical protocol. Interviewers used a semi-structured interview guide to elicit feedback and experiences with starting CGM within 30 days of diagnosis, and the benefits and barriers they experienced when adjusting to this technology. Groups and interviews were audio recorded, transcribed and analysed using content analysis. Results Participants were 16 parents (age 44.13 ± 8.43 years; 75% female; 56.25% non-Hispanic White) of youth (age 12.38 ± 4.15 years; 50% female; 50% non-Hispanic White; diabetes duration 10.35 ± 3.89 months) who initiated CGM 11.31 ± 7.33 days after diabetes diagnosis. Overall, parents reported high levels of satisfaction with starting CGM within a month of diagnosis and described a high level of reliance on the technology to help manage their child's diabetes. All participants recommended early CGM initiation for future families and were committed to continue using the technology for the foreseeable future, provided that insurance covered it. Conclusion Parents experienced CGM initiation shortly after their child's Type 1 diabetes diagnosis as a highly beneficial and essential part of adjusting to living with diabetes.

There are 150 million people with diabetes worldwide who require insulin replacement therapy and the prevalence of diabetes is rising fastest in middle and low-income countries. Current formulations require costly refrigerated transport and storage to prevent loss of insulin integrity. This study shows the development of simple “drop-in” amphiphilic copolymer excipients to maintain formulation integrity, bioactivity, pharmacokinetics and pharmacodynamics for over 6 months when subjected to severe stressed aging conditions that cause current commercial formulation to fail in under 2 weeks. Further, when these copolymers are added to Humulin R (Eli Lilly) in original commercial packaging they prevent insulin aggregation for up to 4 days at 50 °C compared to less than 1 day for Humulin R alone. These copolymers demonstrate promise as simple formulation additives to increase the cold chain resilience of commercial insulin formulations, thereby expanding global access to these critical drugs for treatment of diabetes.

Dual-hormone replacement therapy with insulin and amylin in patients with type 1 diabetes has the potential to improve glucose management. Unfortunately, currently available formulations require burdensome separate injections at mealtimes and have disparate pharmacokinetics that do not mimic endogenous co-secretion. Here, we use amphiphilic acrylamide copolymers to create a stable co-formulation of monomeric insulin and amylin analogues (lispro and pramlintide) with synchronous pharmacokinetics and ultra-rapid action. The co-formulation is stable for over 16 hours under stressed aging conditions that cause a commercial "fast-acting" insulin formulation, Humalog, to aggregate in only 8 hours. The faster insulin pharmacokinetics achieved by delivery of monomeric insulin alongside pramlintide in this new co-formulation resulted in an increased overlap of 75 (s.e. = 6)% compared to only 47 (s.e. = 7)% for separate injections. Pramlintide delivered in the co-formulation resulted in similar delay in gastric emptying compared to pramlintide delivered separately, indicating pramlintide efficacy is maintained in the co-formulation. In a glucose challenge, rats receiving the co-formulation had reduced deviation from baseline glucose compared to treatment with either Humalog alone or separate injections of Humalog and pramlintide. Together these results suggest that a stable co-formulation of monomeric insulin and pramlintide has the potential to improve mealtime glucose management and reduce patient burden in the treatment of diabetes.

Understanding how automated insulin delivery (AID) algorithm features impact glucose control under full closed loop delivery represents a critical step toward reducing patient burden by eliminating the need for carbohydrate entries at mealtimes. Here, we use a pig model of diabetes to compare AndroidAPS and Loop open‐source AID systems without meal announcements. Overall time‐in‐range (70–180 mg/dl) for AndroidAPS was 58% ± 5%, while time‐in‐range for Loop was 35% ± 5%. The effect of the algorithms on time‐in‐range differed between meals and overnight. During the overnight monitoring period, pigs had an average time‐in‐range of 90% ± 7% when on AndroidAPS compared to 22% ± 8% on Loop. Time‐in‐hypoglycemia also differed significantly during the lunch meal, whereby pigs running AndroidAPS spent an average of 1.4% (+0.4/−0.8)% in hypoglycemia compared to 10% (+3/−6)% for those using Loop. As algorithm design for closed loop systems continues to develop, the strategies employed in the OpenAPS algorithm (known as oref1) as implemented in AndroidAPS for unannounced meals may result in a better overall control for full closed loop systems., SHORT ABSTRACT: Understanding how algorithm features impact glucose control after unannounced meals is a critical step toward full closed loop insulin delivery and reduced patient burden. For unannounced meals in a full closed loop system, and with faster insulin pharmacokinetics inherent to pigs, time‐in‐range was greater with open‐source algorithm AndroidAPS than Loop in pigs with diabetes.

Objective We examined whether diabetic ketoacidosis (DKA), a serious complication of type 1 diabetes (T1D) was more prevalent among Non-Hispanic (NH) Black and Hispanic patients with T1D and laboratory-confirmed coronavirus disease 2019 (COVID-19) compared with NH Whites. Method This is a cross-sectional study of patients with T1D and laboratory-confirmed COVID-19 from 52 clinical sites in the United States, data were collected from April to August 2020. We examined the distribution of patient factors and DKA events across NH White, NH Black, and Hispanic race/ethnicity groups. Multivariable logistic regression analysis was performed to examine the odds of DKA among NH Black and Hispanic patients with T1D as compared with NH White patients, adjusting for potential confounders, such as age, sex, insurance, and last glycated hemoglobin A1c (HbA1c) level. Results We included 180 patients with T1D and laboratory-confirmed COVID-19 in the analysis. Forty-four percent (n = 79) were NH White, 31% (n = 55) NH Black, 26% (n = 46) Hispanic. NH Blacks and Hispanics had higher median HbA1c than Whites (%-points [IQR]: 11.7 [4.7], P

Introduction: Renal complications are both a marker of previous suboptimal glycaemic control and a major risk factor for cardiovascular disease in persons with type 1 diabetes (T1D). The aim of the study was to evaluate the prevalence of renal complications in persons with T1D in four geographical regions. Methods: Nationwide registry data from Austria/Germany, Sweden and the US were used to estimate the prevalence of renal complications from January 2016 until September 2018. Chronic kidney disease (CKD) and albuminuria in the study population and each registry were analysed by diabetes duration. Risk factors for renal complications were described by registry. Results: In the total cohort of 78.926 adults with T1D, mean age was 44.4 ± 18.43 years and mean diabetes duration was 21.6 ± 22 years. Mean estimated glomerular filtration rate (eGFR) was 94.0 ± 31.45 ml/min, 13.0% had microalbuminuria and 3.9% had macroalbuminuria. Mean age, diabetes duration, use of insulin pumps and continuous glucose monitoring, as well as presence of albuminuria, varied between registries. Albuminuria was present in approximately 10% of persons with diabetes duration < 20 years and impaired renal function (eGFR < 60 ml/min) was present in 17%. In persons with diabetes duration > 40 years, approximately one-third had albuminuria and 25% had impaired renal function. Conclusions: This analysis used three nationwide registries of persons with T1D. Despite recent use of more effective diabetes therapies, a substantial proportion of persons with T1D have renal complications at < 20 years after diagnosis. Efficient glucose-lowering and renal-protective strategies are needed in persons with T1D. CA extern

The severe acute respiratory syndrome coronavirus 2 (SARS-Cov-2), responsible for the coronavirus disease COVID-19, was first identified in Wuhan, China in December 2019. Diabetes, as well as other cardiovascular comorbidities, has been recognized as a major risk factor for outcomes and mortality in adults with COVID19, particularly in the elderly with type 2 diabetes. Based on these conclusions, COVID-19 data on adults have been generalizedto youth with diabetes. Nevertheless, experience from Pediatric Diabetes practices in China (Wuhan), Italy, Spain (Catalonia) and the US (San Francisco Bay Area) consistently report only a single severe case of COVID-19 in a 20-year-old female youth with type 1 diabetes (T1D) that was hospitalized for bilateral pneumonia and was subsequently discharged without complications. In Italy, information on COVID-19 in all children with diabetes is collected on a weekly basis andthose with positive swab test or infection-related symptoms reported to a dedicated national registry. Of a total of 15,500 children tested,11subjects with T1D (age 8-17y) tested positive for COVID-19; 6/11 were asymptomatic and the rest presented with mild symptoms. In the rest of locations, youth with T1D diagnosed with COVID-19 were based on clinical suspicion and a confirmatory PCR test(Wuhan:0; Catalonia-HSJD:3; California-Stanford:2) and all of them were asymptomatic or had a mild course.We suggest that COVID-19 data from adults should not be generalizedto children, adolescents and youth with diabetes as their outcomes and prognosis seem to be similar to their non-diabetic-peers and consistently milder than adults with diabetes. This article is protected by copyright. All rights reserved.

OBJECTIVE: To address a common perception that hypoglycemia is associated with increased dietary intake, we examined calorie and carbohydrate consumption on days with and without hypoglycemia among adolescents with type 1 diabetes (T1D). METHODS: Days (N=274) with 24-hour dietary recalls and continuous glucose monitoring were available for 122 adolescents with T1D in the Flexible Lifestyle Empowering Change trial (age 13–16 years, diabetes duration >1 year, hemoglobin A1c 8–13%). Days with no hypoglycemia, clinical hypoglycemia (54–69 mg/dL) or clinically serious hypoglycemia (

OBJECTIVE As diabetes technology use in youth increases worldwide, inequalities in access may exacerbate disparities in hemoglobin A1c (HbA1c). We hypothesized that an increasing gap in diabetes technology use by socioeconomic status (SES) would be associated with increased HbA1c disparities. RESEARCH DESIGN AND METHODS Participants aged RESULTS HbA1c was higher in participants with lower SES (in 2010–2012 and 2016–2018, respectively: 8.0% and 7.8% in Q1 and 7.6% and 7.5% in Q5 for DPV; 9.0% and 9.3% in Q1 and 7.8% and 8.0% in Q5 for T1DX). For DPV, the association between SES and HbA1c did not change between the two time periods, whereas for T1DX, disparities in HbA1c by SES increased significantly (P < 0.001). After adjusting for technology use, results for DPV did not change, whereas the increase in T1DX was no longer significant. CONCLUSIONS Although causal conclusions cannot be drawn, diabetes technology use is lowest and HbA1c is highest in those of the lowest SES quintile in the T1DX, and this difference for HbA1c broadened in the past decade. Associations of SES with technology use and HbA1c were weaker in the DPV registry.

Background Changes in cholesterol absorption and cholesterol synthesis may promote dyslipidemia and cardiovascular disease in individuals with type 2 diabetes mellitus (T2DM). Objective To assess cholesterol synthesis and absorption in lean individuals, obese individuals, and individuals with T2DM. Methods We measured lathosterol and lanosterol (markers of cholesterol synthesis) as well as campesterol and β-sitosterol (markers of cholesterol absorption) in the serum of 15-26 years old individuals with T2DM (n = 95), as well as their lean (n = 98) and obese (n = 92) controls. Results Individuals with T2DM showed a 51% increase in lathosterol and a 65% increase in lanosterol compared to lean controls. Similarly, obese individuals showed a 31% increase in lathosterol compared to lean controls. Lathosterol and lanosterol were positively correlated with body mass index, fasting insulin and glucose, serum triglycerides, and C-reactive protein, and negatively correlated with HDL-cholesterol. In contrast, campesterol and β-sitosterol were not altered in individuals with T2DM. Moreover, campesterol and β-sitosterol were negatively correlated with body mass index, fasting insulin, and C-reactive protein and were positively correlated with HDL-cholesterol. Conclusions Adolescents and young adults with T2DM show evidence of increased cholesterol synthesis compared to non-diabetic lean controls. These findings suggest that T2DM may promote cardiovascular disease by increasing cholesterol synthesis, and provide additional rationale for the use of cholesterol synthesis inhibitors in this group. This article is protected by copyright. All rights reserved.

Objective: The T1D Exchange Clinic Registry figure of HbA1c levels according to age has become a classic picture of how average HbA1c varies from childhood to elderly. To further assess the course of HbA1c across the life span in T1D, we created similar figures stratified by device use and socioeconomic status (SES). Methods: Mean HbA1c was plotted versus age for 21,253 T1D Exchange Clinic Registry participants with an HbA1c measurement between January 1, 2016 and March 31, 2018 according to device use, race/ethnicity, and measures of SES. Results: Across the age range from childhood to elderly, continuous glucose monitoring (CGM) use without an insulin pump had better average HbA1c than pump without CGM; and among CGM users, pump and injection users had similar HbA1c levels. Any device use (pump or CGM) was associated with better HbA1c levels than no device use across the age range. Lower SES and African American race were associated with higher HbA1c across the age range. Across all device use, SES, and race/ethnicity factors, average HbA1c levels were highest in adolescents and young adults. Conclusion: Although the plot of average HbA1c from early childhood to elderly shifts according to device use and SES factors, the shape of the plots remains reasonably constant with highest HbA1c levels in adolescents and young adults. These findings emphasize the importance of targeting adolescence and early adulthood as the ages with the greatest need for improving diabetes management irrespective of device use and SES.

Introduction Youth with type 1 diabetes (T1D) commonly do not meet HbA1c targets. Youth-directed goal setting as a strategy to improve HbA1c has not been well characterized and associations between specific goal focus areas and glycemic control remain unexplored. Objective To inform future trials, this analysis characterized intended focus areas of youth self-directed goals and examined associations with change in HbA1c over a 18 months. Methods We inductively coded counseling session data from youth in the Flexible Lifestyle Empowering Change Intervention (n = 122, 13-16 years, T1D duration >1 year, HbA1c 8-13%) to categorize intended goal focus areas and examine associations between frequency of goal focus areas selected by youth and change in HbA1c between first and last study visit. Results We identified 13 focus areas that categorized youth goal intentions. Each session where youth goal setting concurrently incorporated blood glucose monitoring (BGM), continuous glucose monitoring (CGM), and insulin dosing was associated with a 0.4% (95% CI: -0.77, -0.01; P = .03) lower HbA1c at the end of intervention participation. No association was observed between HbA1c and frequency of sessions where goal intentions focused on BG only (without addressing insulin or CGM) (β: 0.07; 95% CI: -0.07, 0.21; P = .33) nor insulin dosing only (without addressing BGM or CGM) (β: 0.00; 95% CI: -0.11, 0.10; P = .95). Conclusions Findings exemplify how guiding youth goal development and combining multiple behaviors proximally related to glycemic control into goal setting may benefit HbA1c among youth with T1D. More research characterizing optimal goal setting practices in youth with T1D is needed.

Objective Continuous glucose monitor (CGM) use is associated with improved glucose control. We describe the effect of continued and interrupted CGM use on hemoglobin A1c (HbA1c) in youth with public insurance. Methods We reviewed 956 visits from 264 youth with type 1 diabetes (T1D) and public insurance. Demographic data, HbA1c and two-week CGM data were collected. Youth were classified as never user, consistent user, insurance discontinuer, and self-discontinuer. Visits were categorized as never-user visit, visit before CGM start, visit after CGM start, visit with continued CGM use, visit with initial loss of CGM, visit with continued loss of CGM, and visit where CGM is regained after loss. Multivariate regression adjusting for age, sex, race, diabetes duration, initial HbA1c, and BMI were used to calculate adjusted mean and delta HbA1c. Results Adjusted mean HbA1c was lowest for the consistent user group (HbA1c 8.6%;[95%CI 7.9,9.3]). Delta HbA1c (calculated from visit before CGM start) was lower for visit after CGM start (-0.39%;[95%CI -0.78,-0.02]) and visit with continued CGM use (-0.29%;[95%CI -0.61,0.02]) whereas it was higher for visit with initial loss of CGM (0.40%;[95%CI -0.06,0.86]), visit with continued loss of CGM (0.46%;[95%CI 0.06,0.85]), and visit where CGM is regained after loss (0.57%;[95%CI 0.06,1.10]). Conclusions Youth with public insurance using CGM have improved HbA1c, but only when CGM use is uninterrupted. Interruptions in use, primarily due to gaps in insurance coverage of CGM, were associated with increased HbA1c. These data support both initial and ongoing coverage of CGM for youth with T1D and public insurance. This article is protected by copyright. All rights reserved.

Many youth with type 1 diabetes (T1D) do not achieve hemoglobin A1c (HbA1c) targets. The mean HbA1c of youth in the USA is higher than much of the developed world. Mean HbA1c in other nations has been successfully modified following benchmarking and quality improvement methods. In this review, we describe the novel 4T approach—teamwork, targets, technology, and tight control—to diabetes management in youth with new-onset T1D. In this program, the diabetes care team (physicians, nurse practitioners, certified diabetes educators, dieticians, social workers, psychologists, and exercise physiologists) work closely to deliver diabetes education from diagnosis. Part of the education curriculum involves early integration of technology, specifically continuous glucose monitoring (CGM), and developing a curriculum around using the CGM to maintain tight control and optimize quality of life.

Islet autoantibodies are predominantly measured by radioassay to facilitate risk assessment and diagnosis of type 1 diabetes. However, the reliance on radioactive components, large sample volumes and limited throughput renders radioassay testing costly and challenging. We developed a multiplex analysis platform based on antibody detection by agglutination-PCR (ADAP) for the sample-sparing measurement of GAD, IA-2 and insulin autoantibodies/antibodies in 1 μL serum. The assay was developed and validated in 7 distinct cohorts (n = 858) with the majority of the cohorts blinded prior to analysis. Measurements from the ADAP assay were compared to radioassay to determine correlation, concordance, agreement, clinical sensitivity and specificity. The average overall agreement between ADAP and radioassay was above 91%. The average clinical sensitivity and specificity were 96% and 97%. In the IASP 2018 workshop, ADAP achieved the highest sensitivity of all assays tested at 95% specificity (AS95) rating for GAD and IA-2 autoantibodies and top-tier performance for insulin autoantibodies. Furthermore, ADAP correctly identified 95% high-risk individuals with two or more autoantibodies by radioassay amongst 39 relatives of T1D patients tested. In conclusion, the new ADAP assay can reliably detect the three cardinal islet autoantibodies/antibodies in 1μL serum with high sensitivity. This novel assay may improve pediatric testing compliance and facilitate easier community-wide screening for islet autoantibodies.