New-onset Type Research Articles

Early weight gain after diagnosis may have an impact on remission status in children with new-onset type 1 diabetes mellitus.

Residual beta-cell function and improvement in insulin sensitivity by reversal of glucose toxicity are two phenomena thought to be related to partial remission (PR). Body fat mass is the major determinant of insulin sensitivity. The aim of this study is to investigate the relationship between the rate of body weight gain after diagnosis of type 1 diabetes mellitus (T1DM) and other clinical factors for the development and duration of PR. Children (2-16 years) with new-onset T1DM (n = 99) were grouped into remitters and non-remitters by using insulin dose-adjusted glycosylated hemoglobin (HbA1c) values. Laboratory and clinical data as well as daily insulin requirement per kilogram of body weight at diagnosis and each visit were recorded, and the duration of PR was determined. Changes in body mass index standard deviation score (BMI-SDS) were calculated by the auxological data collected every 6 months. There were 47 remitters (47.5%) and 52 (52.5%) non-remitters. The mean increase in BMI-SDS at the first 6 months of diagnosis was higher in the non-remitters than in the remitters (p = 0.04). Duration of PR was negatively correlated with the change in BMI-SDS between 6 and 12 months after diagnosis. Male sex, younger age, prepubertal status, and lower HbA1c were predictors of remission, among which male sex had the highest chance by multivariate regression. Early rapid weight gain after diagnosis of T1DM may play a role in the lack of remission and shorter duration of PR. Interventions to prevent early rapid weight gain can maintain the development and prolongation of remission.

Risk of New-onset Type 1 Diabetes in Danish Children and Adolescents After SARS-CoV-2 Infection: A Nationwide, Matched Cohort Study.

We investigated the association between SARS-CoV-2 infection and new-onset type 1 diabetes (T1D) in children and adolescents in a nationwide, matched cohort study. The hazard ratio of new-onset T1D within 6 months after SARS-CoV-2 infection was 1.22 (0.58-2.58). The risk of new-onset T1D in children and adolescents was not significantly increased after SARS-CoV-2 infection.

Rash in a Patient With New-Onset Type 1 Diabetes Mellitus

Rash in a Patient With New-Onset Type 1 Diabetes Mellitus

Statin-induced miR-33a and miR-27b up-regulation contributes to the development of new-onset type 2 diabetes

Statin-induced miR-33a and miR-27b up-regulation contributes to the development of new-onset type 2 diabetes

A Plasma miR-193b-365 Signature Combined With Age and Glycemic Status Predicts Response to Lactococcus lactis-Based Antigen-Specific Immunotherapy in New-Onset Type 1 Diabetes.

Low-dose anti-CD3 combined with oral gavage of genetically modified Lactococcus lactis bacteria secreting human proinsulin and IL-10 holds great promise to arrest autoimmune type 1 diabetes, but the absence of biomarkers predicting therapeutic success hampers clinical translation. A set of cell-free circulation miRNAs together with age and glycemia at baseline predicts a poor response after L. lactis-based immunotherapy in nonobese mice with new-onset diabetes. Pancreas-infiltrating neutrophils and basophils are identified as potential cellular sources of discovered miRNAs. The prognostic signature could guide targeted recruitment of patients with newly diagnosed type 1 diabetes in clinical trials with the L. lactis-based immunotherapy.

Pediatric COVID-19 and Diabetes: An Investigation into the Intersection of Two Pandemics.

Coronavirus disease 2019 (COVID-19) is a complex infectious disease caused by the SARS-CoV-2 virus, and it currently represents a worldwide public health emergency. The pediatric population is less prone to develop severe COVID-19 infection, but children presenting underlying medical conditions, such as diabetes mellitus, are thought to be at increased risk of developing more severe forms of COVID-19. Diabetic children face new challenges when infected with SARS-CoV-2. On one hand, the glycemic values become substantially more difficult to manage as COVID-19 is a predisposing factor for hyperglycemia. On the other hand, alongside other risk factors, high glycemic values are incriminated in modulating immune and inflammatory responses, leading to potentially severe COVID-19 cases in the pediatric population. Also, there are hypotheses of SARS-CoV-2 being diabetogenic itself, but this information is still to be confirmed. Furthermore, it is reported that there was a noticeable increase in the number of cases of new-onset type 2 diabetes among the pediatric population, and the complications in these patients with COVID-19 include the risk of developing autoimmune diseases under the influence of stress. Additionally, children with diabetes mellitus are confronted with lifestyle changes dictated by the pandemic, which can potentially lead to the onset or exacerbation of a potential underlying anxiety disorder or depression. Since the literature contains a series of unknowns related to the impact of COVID-19 in both types of diabetes in children, the purpose of our work is to bring together the data obtained so far and to identify potential knowledge gaps and areas for future investigation regarding COVID-19 and the onset of diabetes type 1 or type 2 among the pediatric population.

Diabetic Ketoacidosis and Long-term Insulin Requirements in Youths with Newly Diagnosed Type 2 Diabetes During the SARS-CoV-2 Pandemic

ObjectiveSARS-CoV-2 infection increases the risk of diabetes and diabetic ketoacidosis (DKA) in both adults and children. We investigated the clinical course of new-onset type 2 diabetes in youth presenting with DKA during the COVID-19 pandemic. MethodsThis single-center retrospective cohort study included 148 subjects with obesity aged 10 to 21 years, admitted with DKA from January 2018 to January 2022. Groups were defined by the presence of DKA precipitant: any infection (n = 38, 26%), which included the SARS-CoV-2 (n = 10, 7%) and other infection (n = 28, 19%) groups, and no infection (n = 110, 74%). The primary outcome was insulin discontinuation within a 12-month follow-up. ResultsThe mean age was 14.9 years (IQR, 13.8-16.5), and age-adjusted body mass index (%) was 99.1 (IQR, 98.0-99.5) with 85.8% identifying as Black or Hispanic. There were no differences in DKA severity among groups. The incidence of DKA was higher during the pandemic (March 2020-January 2022, n = 117) than in the prepandemic period (January 2018-February 2020, n = 31). Within the first year after the acute DKA episode, 46 patients discontinued all insulin within 9 months (IQR, 4-14). Sixteen subjects restarted insulin 10 months (IQR, 6.5-11.0) after insulin discontinuation. Infection with SARS-CoV-2 at diagnosis was not associated with the likelihood (P =.57) or timing (P =.27) of discontinuing all insulin within 1 year, nor was having any infection. ConclusionThe incidence of DKA at the onset of type 2 diabetes was higher during the SARS-CoV-2 pandemic than in the prepandemic period. SARS-CoV-2 infection was not associated with DKA severity or insulin discontinuation within the first year of diagnosis in youth with new-onset type 2 diabetes and DKA.

Both LDL and HDL particle concentrations associate positively with an increased risk of developing microvascular complications in patients with type 2 diabetes: lost protection by HDL (Zodiac-63)

BackgroundTriglyceride-rich lipoproteins (TRL) and low-density lipoproteins (LDL) are associated positively whereas high-density lipoproteins (HDL) are associated inversely with the development of new-onset type 2 diabetes (T2D). Here we studied potential associations between these lipoprotein particle concentrations and the risk of developing microvascular complications in patients with established T2D.MethodsLipoprotein particle concentrations (TRLP, LDLP, and HDLP) were determined in 278 patients with T2D participating in a primary care-based longitudinal cohort study (Zwolle Outpatient Diabetes project Integrating Available Care [ZODIAC] study) leveraging the Vantera nuclear magnetic resonance (NMR) platform using the LP4 algorithm. Associations between lipoprotein particles and incident microvascular complications (nephropathy, neuropathy, and retinopathy) were assessed using Cox proportional hazards regression models.ResultsIn total, 136 patients had microvascular complications at baseline. During a median follow-up of 3.2 years, 49 (34.5%) of 142 patients without microvascular complications at baseline developed new-onset microvascular complications. In multivariable Cox proportional hazards regression analyses, both total LDLP and HDLP concentrations, but not total TRLP concentrations, were positively associated with an increased risk of developing any microvascular complications after adjustment for potential confounding factors, including age, sex, disease duration, HbA1c levels, history of macrovascular complications, and statin use (adjusted hazard ratio [HR] per 1 SD increment: 1.70 [95% CI 1.24–2.34], P < 0.001 and 1.63 [95% CI 1.19–2.23], P = 0.002, respectively). When analyzing each microvascular complication individually, total LDLP concentrations were positively associated with retinopathy (adjusted HR 3.35, 95% CI 1.35–8.30, P = 0.009) and nephropathy (adjusted HR 2.13, 95% CI 1.27–3.35, P = 0.004), and total HDLP concentrations with neuropathy (adjusted HR 1.77, 95% CI 1.15–2.70, P = 0.009). No significant associations were observed for lipoprotein particle subfractions.ConclusionsTotal lipoprotein particle concentrations of both LDL and HDL associate positively with an increased risk of developing microvascular complications in T2D. We propose that the protective role of HDL on the development of microvascular complications may be lost in established T2D.

Prolonged clinical remission of type 1 diabetes sustained by calcifediol and low-dose basal insulin: a case report.

Herein, we describe an unusually prolonged duration (31months) of the clinical remission phase in a 22-year-old Italian man with new-onset type 1 diabetes. Shortly after the disease diagnosis, the patient was treated with calcifediol (also known as 25-hydroxyvitamin D3 or calcidiol), coupled with low-dose basal insulin, to correct hypovitaminosis D and to exploit the anti-inflammatory and immunomodulatory properties of vitamin D. During the follow-up period, the patient retained a substantial residual β-cell function and remained within the clinical remission phase, as evidenced by an insulin dose-adjusted glycated hemoglobin value <9. At 24 months, we detected a peculiar immunoregulatory profile of peripheral blood cells, which may explain the prolonged duration of the clinical remission sustained by calcifediol as add-on treatment to insulin.

Possible sarcopenia and risk of new-onset type 2 diabetes mellitus in older adults in China: a 7-year longitudinal cohort study

BackgroundPrevious studies have shown that type 2 diabetes mellitus (T2DM) can cause sarcopenia; however, these conditions may have a bidirectional association. This study aimed to explore the longitudinal association between possible sarcopenia and new-onset T2DM.MethodsWe conducted a population-based cohort study using nationally representative data from the China Health and Retirement Longitudinal Study (CHARLS). This study included participants aged ≥ 60 years who were free of diabetes during the baseline survey of CHARLS (2011 to 2012) and were followed up until 2018. Possible sarcopenia status was defined according to the Asian Working Group for Sarcopenia 2019 criteria. Cox proportional hazards regression models were used to evaluate the effect of possible sarcopenia on new-onset T2DM.ResultsIn total, 3,707 individuals were enrolled in this study, with a median age of 66 years; the prevalence of possible sarcopenia was 45.1%. During the 7-year follow-up, 575 cases (15.5%) of incident diabetes were identified. Participants with possible sarcopenia were more likely to have new-onset T2DM than those without possible sarcopenia (hazard ratio: 1.27, 95% confidence interval: 1.07–1.50; p = 0.006). In subgroup analysis, we found a significant association between possible sarcopenia and T2DM in individuals aged < 75 years or with a BMI < 24 kg/m². However, this association was not significant in individuals aged ≥ 75 years or with a BMI ≥ 24 kg/m².ConclusionsPossible sarcopenia is associated with an increased risk of new-onset T2DM in older adults, especially in individuals who are not overweight and aged 75 years or younger.

Presentation of new onset type 1 diabetes with diabetic ketoacidosis and hyperosmolar hyperglycaemia after a single dose of nivolumab and ipilimumab.

A Caucasian man in his 60s with recent diagnosis of metastatic renal cell carcinoma presented to the emergency department with a 5-day history of severe polyuria, polydipsia and fatigue and 1-day history of confusion, abdominal pain, nausea and vomiting. Investigations revealed an overlap of diabetic ketoacidosis (DKA) and hyperosmolar hyperglycaemic state (HHS). He had received the first dose of immunotherapy with nivolumab and ipilimumab 3 weeks prior to this attendance. New-onset type 1 diabetes (T1DM) was confirmed based on the clinical features at presentation, seropositivity for glutamic acid decarboxylase antibodies and significant insulin deficiency. He is currently on a multiple daily injections of insulin and uses intermittent-scanned glucose monitoring. Given the irreversible impact on beta-cell function and clinical response with insulin resulting in improved diabetes control, immunotherapy was resumed for his metastatic cancer with good radiological response. Although rare, new-onset T1DM can present with DKA and HSS overlap after a single dose of nivolumab/ipilimumab in individuals without pre-existing history of diabetes. Although rare, new onset of T1DM after immunotherapy can present with DKA and HSS overlap after a single dose of nivolumab/ipilimumab in individuals without pre-existing history of diabetes and normal glycaemic parameters. Due to the irreversible destruction of beta-cells, treatment with steroids is not indicated in contrast to other settings such as immunotherapy-induced hypophysitis. Presence of low c-peptide levels post-acute presentation is indicative of an irreversible impact on beta-cell function and supports resuming immunotherapy given the significant benefits on cancer prognosis. Clinicians must maintain a high index of suspicion in regards to diagnosis and management of new-onset type 1 diabetes and advice patients on reporting symptoms suggestive of diabetes and/or diabetes-related hyperglycaemic emergencies.

Clonal hematopoiesis as a novel risk factor for type 2 diabetes mellitus in patients with hypercholesterolemia.

Clonal hematopoiesis of indeterminate potential (CHIP) is associated with atherosclerosis and cardiovascular disease. It has been suggested that CHIP may be related to diabetes, so we investigated the association between CHIP and new-onset type 2 diabetes. This study included 4,047 subjects aged >=40 years without diabetes. To detect CHIP, targeted gene sequencing of genomic DNA from peripheral blood cells was performed. The incidence of new-onset type 2 diabetes during the follow-up period was evaluated. Of the total subjects, 635 (15.7%) had CHIP. During the median follow-up of 5.1 years, the incidence of new-onset diabetes was significantly higher in CHIP carriers than in subjects without CHIP (11.8% vs. 9.1%, p = 0.039). In a univariate analysis, CHIP significantly increased the risk of new-onset diabetes (HR 1.32, 95% CI 1.02-1.70, p = 0.034), but in a multivariate analysis, it was not significant. The CHIP-related risk of new onset diabetes differed according to LDL cholesterol level. In the hyper-LDL cholesterolemia group, CHIP significantly increased the risk of diabetes (HR 1.64, 95% CI 1.09-2.47, p = 0.018), but it did not increase the risk in the non-hyper-LDL cholesterolemia group. The subjects with CHIP and hyper-LDL-cholesterolemia had approximately twice the risk of diabetes than subjects without CHIP and with low LDL cholesterol (HR 2.05, 95% CI 1.40-3.00, p < 0.001). The presence of CHIP was a significant risk factor for new-onset type 2 diabetes, especially in subjects with high LDL cholesterol. These results show the synergism between CHIP and high LDL cholesterol as a high-risk factor for diabetes.

Diabetes-Related Quality of Life Assessment in Children following Total Pancreatectomy with Islet Autotransplantation

Total pancreatectomy with islet autotransplantation (TPIAT) can improve pain and reduce functional impairment associated with acute recurrent or chronic pancreatitis. However, long-term glucose monitoring and insulin therapy are often required, which can adversely affect the quality of life. We sought to evaluate diabetes-related quality of life (DR-QOL) in youth who underwent TPIAT and compare it to the youth with new-onset type 1 diabetes (T1D). The Pediatric Quality of Life Inventory™ 3.2 Diabetes Module (PedsQL™ DM) was used to assess DR-QOL in 46 youth (&lt;20 years old) who underwent TPIAT. The PedsQL™ DM scores were analyzed for statistically significant changes and minimally important clinical differences (MCID) over time post-TPIAT. Scores at 12 months (n = 29) and 24 months (n = 16) were then compared to PedsQL™ DM scores from a historical cohort of demographically similar (age and sex) youth with a 12 months (n = 52) and 24 months (n = 58) after diagnosis of T1D. The diabetes symptoms summary score (mean 65 to 57 and p = 0.03 ) and the total score (mean 74 to 68 and p &lt; 0.05 ) decreased (worsened) during the first 24 months post-TPIAT and met the MCID threshold, suggesting the decrease in these scores was clinically significant. Post-TPIAT PedsQL™ DM scores were not significantly different than youth new diagnosis of T1D after 24 months (all p &gt; 0.2 ). In youth who underwent TPIAT, DR-QOL worsened over the first two years, mostly attributable to the diabetes symptoms score. Compared to children with T1D, post-TPIAT DR-QOL was similar two years after diabetes onset.

Satisfaction With Participation in the First STEPS Behavioral Intervention: Experiences of Parents of Young Children With Newly Diagnosed Type 1 Diabetes.

Parents of young children with new-onset type 1 diabetes (T1D) often experience significant distress and struggle with T1D management during a challenging developmental stage. The First STEPS (Study of Type 1 in Early childhood and Parenting Support) trial evaluated a stepped-care behavioral intervention comprising increasingly intensive intervention steps (peer parent coach, cognitive-behavioral counseling, consultations with diabetes educator and psychologist) based on need. The intervention improved parental depressive symptoms compared to usual care. Subsequently, we examined parent satisfaction with the intervention to guide potential implementation and refinement for future trials. Participants were 157 parents of young children newly diagnosed with T1D. At 9 months post randomization, n = 153 completed satisfaction questionnaires and n = 17 completed qualitative interviews. Satisfaction ratings about trial procedures and each intervention step were summarized. We used thematic analysis with the interview transcripts to generate themes related to participants' experiences in the trial overall and intervention specifically. We explored differences in themes between participants who did versus did not respond to the intervention and among those who experienced different intervention steps. Most participants in both arms rated study participation and methods positively (>95%), and those completing interviews described high satisfaction with study procedures overall, retention incentives, and contact with study staff. Intervention participants' satisfaction ratings were high across steps. Two qualitative themes reflected satisfaction with the intervention enhancing self-efficacy and social support. High satisfaction suggests implementing a stepped-care behavioral intervention as part of routine clinical care following T1D diagnosis would be well received.

1442-P: Composite Scores Using Fasting and Stimulated C-Peptide Are Equivalent and Can Track Beta-Cell Function in New-Onset Type 1 Diabetes

Composite scores using fasting samples have been developed to routinely monitor beta cell mass after islet transplantation in type 1 diabetes (T1D). They may also have utility in new onset or T1D prevention trials as an alternative to mixed meal tolerance tests measuring AUC C-peptide. We examined if a composite score using stimulated C-peptide was equivalent to fasting C-peptide in estimating beta cell mass in new onset T1D and reflected changes in AUC C-peptide over time. BETA-2 (fasting C-peptide, glucose, insulin dose, HbA1c) and BETA-2stim (using C-peptide AUC) were calculated in 1312 individuals from the TOMI dataset (median (IQR) age 16y (12, 24); 42% F). The dataset comprises 3200 participants within 100 days of diagnosis across 22 studies. Studies meeting their primary end point were deemed positive. BETA-2 and BETA-2stim were strongly correlated (R2=0.96, p&amp;lt;0.0001) and showed good agreement using Bland-Altman plots. Both BETA-2 and BETA-2stim showed changes over time which mirrored those for AUC C-peptide, but both composite scores showed differences between active and control participants in positive studies by 3 months while differences in AUC C-peptide were not seen until 6 months (Fig1). Composite scores using fasting C-peptide may provide a simple, sensitive and practical tool to monitor beta cell mass without complex stimulation tests in new onset diabetes. Disclosure A.Carr: None. K.S.Collins: None. S.Karpen: None. E.Atabakhsh: None. A.Lam: None. P.Taylor: None. C.Dayan: Advisory Panel; AstraZeneca, Consultant; Provention Bio, Sanofi, Avotres Inc., Other Relationship; Dompé, Merck &amp; Co., Inc. P.A.Senior: Advisory Panel; Novo Nordisk Canada Inc., Consultant; Novo Nordisk Canada Inc., Bayer Inc., Viatris Inc., Vertex Pharmaceuticals Incorporated, ViaCyte, Inc., Insulet Corporation.

1393-P: Remission Incidence and Associated Clinical Factors in New-Onset Type 2 Diabetes under Standard Medical Care—A Population-Based Study

The natural history of type 2 diabetes (T2D) is mostly progressive and patients often die from diabetes-related complications. However, T2D can sometimes improve enough to discontinue medications, and this phenomenon remains poorly understood. Using health examination data from the Korean National Health Insurance Service (KNHIS) for a new-onset T2D cohort, we investigated the incidence of diabetes remission and associated clinical factors. Remission was defined as normal fasting blood glucose levels &amp;lt; 126 mg/dL, an alternative criterion for remission based on expert consensus; patients who reached normal fasting blood glucose levels measured at 2-year intervals after discontinuation of treatment were defined as achieving remission. New-onset T2D patients (N=114,874) from 2009 to 2012 were followed until 2017, and 2,429 patients (2.1%) experienced remission during the study period. No significant difference in age was reported between the remission and non-remission groups. Compared to the non-remission group, the remission group had lower baseline body mass index (25.4 kg/m2 vs. 25.7 kg/m2), lower baseline fasting glucose levels (157.7 mg/dL vs. 177.1mg/dL), and a lower prevalence of hypertension (47.7% vs. 52.2%) and hyperlipidemia (44.4% vs. 48.2%). When investigating treatment methods, the remission rate was lower in patients who used more than three oral hypoglycemic agents including sulfonylurea (5.43% vs. 14.4%), while the rate of insulin users was higher in the remission group (10.5% vs. 8.0%). When weight change within 2 years before and after remission was reviewed through health examination results, the group that succeeded in weight loss of 5% or more had a significantly higher rate of remission. In summary, remission was observed at rates as low as 2.1% in patients in standard medical care settings. Weight loss and insulin therapy in early T2D patients are thought to lead a favorable prognosis in terms of remission. Disclosure K. Song: None. J. Kim: None. K. Han: None. H. Kwon: None. Funding National Research Foundation of Korea (2021R1A2C2013890)

155-LB: Econsults—An Innovative Model for Diabetes Specialty Care Delivery

Background: More than 10% of the US population has diabetes. However, a national shortage of endocrinologists limits access to diabetes specialty care, creating a delay of several weeks to months for a new patient appointment in endocrine clinic. Econsults, which are asynchronous provider-to-provider communications embedded in the electronic medical record, are a relatively new pathway to seek consultation from specialists. The most common reason for endocrine econsult is uncontrolled diabetes. However, there is little evidence on effectiveness of econsults in improving diabetes control. Methods: We completed a retrospective chart review of all endocrine econsults that were completed for adults with diabetes within a large integrated health system in 2022. We compared HbA1c values before and 3, 6, 12 months after econsult to assess glycemic change. We also analyzed how many econsults were followed by an endocrinology office visit. Results: Of 212 diabetes econsults completed in 2022, 8% (16/212) were for type 1 DM, and 92% (196/212) were for type 2 DM management. Follow-up HbA1c values were available in 189 patients. Eighty-eight percent (166/189) of patients had improvement in HbA1c 12 months following econsult. Only 15% (32/212) of all econsults were followed by a video or in-person visit with an endocrinologist, while 85% (180/212) did not require a follow-up endocrine appointment. Of the patients who only received econsult, mean HbA1c improved from 9.9% at baseline to 7.4% at 12 months (p&amp;lt;0.05). Of the 31 patients with type 2 DM who required a follow-up appointment with endocrinologist, mean HbA1c improved from 10.4% at baseline to 7.1% post-visit (p&amp;lt;0.05). Of note, 6 patients were diagnosed with new-onset type 1 DM during econsult process and were triaged to an immediate video visit to start appropriate insulin treatment and prevent DKA. Conclusion: Econsult is an efficient and effective model which can expand access to diabetes specialty care for patients with uncontrolled diabetes. Disclosure E. Karslioglu-French: Research Support; Abbott. M. Zupa: None. J. Quaytman: None. Funding Pittsburgh Foundation Grant (MR2022-128717)

1116-P: Increase in the Incidence of Type 2 Diabetes in Children &amp;lt;11 Years during the COVID-19 Pandemic

Objectives: To analyze the incidence and characteristics of new-onset type 2 diabetes (T2D) in youth &amp;lt; 11years prior to and during the COVID-19 pandemic, and to compare the metabolic parameters at presentation in younger (&amp;lt; 11 years) versus older youth (11-21 years). Study methods: We performed a retrospective chart review of newly diagnosed T2D among youth &amp;lt; 21 years at Hasbro Children's Hospital between 1/1/2017 and 12/31/2021. We analyzed the incidence of cases presenting at &amp;lt; 11 years pre (1/1/2017 to 2/29/20) and during (3/1/20-12/31/21) the COVID-19 pandemic. We compared metabolic parameters of those presenting &amp;lt; 11years to ≥ 11 years during the pandemic. Results:Eight youth &amp;lt; 11 years (8/145, (5.5 %)) presented with new-onset T2D during the study period (Table1), and all presented during the pandemic (8/89, 9%). Compared to older youth, those &amp;lt; 11years had higher BMI percentile (166% of the 95th%tile ± 38.4 vs. 139.4% ± 42.6, p=0.03), and were more likely to have diastolic hypertension (62.5% vs. 23.8%, p=0.03). Conclusions: We report an abrupt rise in the incidence of new-onset T2D in children &amp;lt; 11 years during the COVID-19 pandemic. Compared to older youth, younger children were more obese, and were more likely to have diastolic hypertension. Further study is needed to elucidate contributing factors to this concerning finding, and to further aid in pediatric T2D prevention. Disclosure S.Sasidharan pillai: None. P.Has: None. L.S.Topor: None. M.E.Fredette: None.

1289-P: Predictors of New-Onset Type 2 Diabetes after Infection with COVID-19 in the COVID-OUT Randomized Trial

Background: There are mixed data on whether COVID-19 infection is associated with increased incidence of type 2 diabetes (T2DM). The majority of data have been derived from retrospective datasets. We sought to identify predictors of new onset T2DM in a prospective cohort enrolled in the multi-site phase 3 randomized quadruple-blinded placebo-controlled COVID-OUT clinical trial. Methods: Adults with overweight or obesity aged 30-85 were enrolled within 3 days of a positive SARS-CoV-2 test and &amp;lt;7 days of symptoms. Participants were randomized to 1 or 2 of 3 oral medications (immediate-release metformin increasing over 6 days to 1500 mg daily for a total of 14 days; ivermectin 430mcg/kg/day for 3 days; fluvoxamine 50mg day 1 then 50mg twice daily through 14 days) or placebo using a two by three parallel treatment factorial design. Starting 60 days after randomization we sent automated email surveys every 30 days through 300 days about new diabetes diagnoses, as well as changes in weight and sleep. We conducted univariable analyses to determine predictors of T2DM diagnosis. Results: Among 1093 subjects, 25 reported a new diagnosis of diabetes within 300 days of COVID-19 infection. There were no significant differences in incidence by treatment arm or vaccination in univariate analysis. Participants with new onset T2DM had a higher baseline BMI (OR 1.08, 95% CI 1.03 to 1.13), and were more likely to report weight gain between the start of the pandemic and their first infection and more likely to report difficulty sleeping, OR 1.04 (95% CI 1.01 to 1.07) and OR 2.86 (95% CI 1.16 to 7.06), respectively. Multivariate analysis is pending. Conclusions: Patients with higher BMIs at baseline, those who gained weight between the onset of the pandemic and their first COVID-19 infection, or had difficulty sleeping were more likely to develop T2DM. Covid treatment with metformin, ivermectin, and fluvoxamine and vaccination status were not significant predictors of new T2DM. Disclosure J.M.Nicklas: None. E.J.Lemus wirtz: None. T.A.Murray: None. D.Liebovitz: None. S.Fenno: None. B.Anderson: None. N.Avula: None. N.Reddy: None. C.Bramante: None. Funding Rainwater Foundation; Parsemus Foundation; United Health Foundation; National Center for Advancing Translational Sciences (KL2TR002492, UL1TR002494); National Institute of Diabetes and Digestive and Kidney Diseases (K23DK124654-01-A1); National Heart, Lung, and Blood Institute (K23HL133604)

212-LB: Implementation of the Avantect Pancreatic Cancer Test in Newly Diagnosed Type 2 Diabetes Patients in a Clinical Setting

Pancreatic Cancer (PaC) is the 3rd leading cause of cancer mortality and is predicted to be the 2nd-leading cause by 2030. PaC and lacks effective early detection tools. Studies have identified patients with new-onset type II diabetes (diagnosis made ≤36 months; NOD) as a high-risk patient population that could benefit from early detection of PaC. ClearNote Health has validated a non-invasive, blood-based, epigenomic early-detection pancreatic test called Avantect. The test has been validated in a large case-control study, including patients with NOD. A pilot program to deploy the test in a clinical setting of NOD was conducted to assess the feasibility and integration of the test into a clinical workflow. Fifty patients received the Avantect test from ClearNote Health. Test results were delivered to the clinical site for post-test follow-up. Feedback on the clinical impact of the testing and logistics were reviewed at the conclusion of testing. The cohort consisted of 30 males (60%) and 20 females (40%). The average patient age was 68 years (range 38-87), and patients had an average time from diabetes diagnosis to testing of 22.9 months (range 1-36). A family history of PaC was observed in 29/50 patients (58%). Of the 50 total test orders, the required test blood volume of 10 mL was obtained in 45 patients (90%). These results included 43 patients with no abnormal signal detected (95.6%), and two patients with an abnormal signal detected (4.4%). The two abnormal signal-detected results are awaiting further clinical evaluation. These results demonstrate early success in the delivery of the Avantect test to the clinical practice of diabetic patients. The test is tailored to facilitate clinical implementation because of its non-invasive nature and its high-performance characteristics (sensitivity - 66.7%; sensitivity- 96.9%). Disclosure S. Chowdhury: Employee; ClearNote Health. D. Haan: Employee; ClearNote Health. W. Volkmuth: Employee; ClearNote Health. S. Levy: Employee; ClearNote Health. A. Vilalta: Consultant; ClearNote Health. M. Collins: Employee; ClearNote Health. M. Riviere: Employee; ClearNote Health. V. Lopez: Employee; ClearNote Health. A. Leighton: Employee; ClearNote Health. M. Antony: Employee; ClearNote Health. E. Nilson: Employee; ClearNote Health. A. Bergamaschi: Employee; ClearNote Health.