A1c Levels Research Articles

Short-term cost-effectiveness of oral semaglutide versus empagliflozin, sitagliptin, and liraglutide in the treatment of Type 2 diabetes in Greece

Diabetes is a significant global health concern, affecting more than 540 million people worldwide and imposing a substantial financial burden on health systems and societies. This study evaluates the cost per patient of achieving treatment targets with oral semaglutide compared to empagliflozin, sitagliptin, and liraglutide in patients with Type 2 diabetes in Greece. The analysis focuses on seven outcomes, including hemoglobin A1C levels, avoidance of hypoglycemia, and weight loss, with costs calculated in 2024 EUR, excluding patient copayments. The annual treatment costs were EUR 1,210.04 for oral semaglutide, EUR 528.04 for empagliflozin, EUR 260.51 for sitagliptin, and EUR 1,542.87 for liraglutide. Although a higher proportion of patients achieved treatment goals with oral semaglutide, it was associated with a higher cost of control across most outcomes compared to empagliflozin (mean probabilistic sensitivity analysis [PSA] difference: EUR 839.45) and sitagliptin (mean PSA difference: EUR 1,041.50). In contrast, oral semaglutide demonstrated a consistently lower cost of control compared to liraglutide across all treatment targets (mean PSA difference: EUR −3,779.23). This analysis confirms that the cost of control of oral semaglutide varies significantly depending on the treatment target, suggesting that, without changes in its list or net price, it may not be the most cost-effective option compared to empagliflozin and sitagliptin in Greece.

Bacterial and clinical metabolic signatures and their interactions in obese patients post-bariatric surgery

BackgroundObesity is a growing health concern in China, closely linked to metabolic disorders such as type 2 diabetes. Laparoscopic Sleeve Gastrectomy (LSG) is effective in promoting weight loss and improving metabolic outcomes. Emerging evidence highlights the role of gut microbiota in metabolic regulation, yet the specific alterations in gut microbiota and their association with metabolic changes post-surgery in Chinese patients remain unclear. Understanding these shifts could provide key insights into optimizing treatment strategies for metabolic improvement following bariatric surgery.MethodsStool samples and clinical data were collected from 30 obese patients before and 6 months after surgery. The composition of the gut microbiota was analyzed through 16S rRNA sequencing, and Spearman correlation analysis was used to determine the association between gut microbiota and clinical indicators.ResultsThe analysis of 30 patients showed a significant decrease in Body Mass Index (BMI) (36.75 ± 4.09 kg/m2 vs 26.37 ± 3.47 kg/m2, p < 0.0001). Glucose metabolism, including Hemoglobin A1C levels, improved significantly (6.05 ± 0.96 vs 5.05 ± 0.25, p < 0.0001), and liver function as well as serum lipid levels were also notably improved. LSG increased the richness and composition of gut microbiota in obese patients post-surgery. These changes in gut microbiota were closely associated with improved clinical metabolic parameters.ConclusionLSG not only significantly reduces body weight while also alleviating metabolic syndrome and comorbidities by altering gut microbiota.

Effect of continuous inhaled corticosteroids on glycated hemoglobin in asthmatic children: a pilot study

BackgroundAsthma is a prevalent chronic disease with significant impact on patients, families, and communities. Inhaled corticosteroids (ICS) are the mainstay of treatment for persistent and uncontrolled asthma. However, concerns remain about the potential adverse effects of ICS, including HbA1c level. This study aims to evaluate the influence of ICS on Hemoglobin A1c (HbA1c) levels in children with bronchial asthma.MethodsThis prospective cohort study included 48 pediatric asthma patients aged 2 to 15 years who had been using ICS for at least 6 months. Comprehensive clinical assessments and measurements of HbA1c levels were conducted at the start of recruitment and after 6 months of ICS use. The types and doses of ICS used followed the guidelines provided by the Global Initiative for Asthma (GINA).ResultsThe initial HbA1c levels ranged from 4.46 to 6.11, with a mean of 5.32 ± 0.35. Three patients (6.3%) had persistent prediabetes status after 6 months. There was no significant relationship between glycemic status and the characteristics of ICS. The duration of ICS therapy and the doses used did not significantly affect HbA1c levels. A weak positive correlation was observed between initial and subsequent HbA1c levels.ConclusionThe study found no significant difference in HbA1c levels among asthmatic children using ICS after six months of treatment. Additionally, there was no significant difference in HbA1c levels between patients using different types of ICS. Regular monitoring of HbA1c levels is recommended, particularly for children on high doses or prolonged use of inhaled Fluticasone.

Is early pregnancy hemoglobin A1c useful to predict gestational diabetes mellitus diagnosed during mid pregnancy?

To verify whether hemoglobin A1c (HbA1c) levels in early pregnancy can predict the diagnosis of gestational diabetes mellitus (GDM) in mid-pregnancy. This was a retrospective cohort study of 2008 pregnant women who delivered singletons at the Yokohama City university Medical Center. Concomitant or history of diabetes mellitus and overt diabetes in pregnancy were excluded. Pregnant women at high risk for GDM underwent a one-step 75-g oral glucose tolerance test (OGTT) during mid-pregnancy. For other pregnant women, GDM was diagnosed by a two-step 75-g oral glucose tolerance test (OGTT) when the 50-g glucose challenge test result in mid-pregnancy was ≥140 mg/dL. The thresholds for 75-g OGTT followed those of the International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria (92-180-153 mg/dL). The relationship between HbA1c level measured at <20 weeks of gestation and GDM diagnosis at mid pregnancy was assessed using a receiver operating characteristic curve (ROC); area under the curve (AUC) and optimal cutoff value of HbA1c, predictive of GDM were calculated. The median HbA1c level at <20 weeks of gestation was 5.3%, and 8.5% of women were diagnosed with GDM. In the ROC curve of the GDM diagnosis rate by HbA1c level, AUC was 0.706, and the optimal cutoff value was 5.4%, with a sensitivity of 0.6176, specificity of 0.6834, positive predictive value of 15.4%, and negative predictive value of 95.1%. Although HbA1c at less than 20 weeks of gestation is acceptable discrimination as a diagnostic tool of GDM in mid-pregnancy, it is not clinically useful to predict GDM in mid-pregnancy.

Categorization of mHealth Coaching Technologies for Children or Adolescents With Type 1 Diabetes: Systematic Review.

Managing type 1 diabetes in children and adolescents can be difficult for parents, health care professionals, and even patients. However, over the last decades, the quality of services provided to patients with diabetes has increased due to advances in IT. This study aims to comprehensively document the range of IT tools used in the management of diabetes among children and adolescents, with a focus on identifying the technologies most commonly used based on their frequency. In addition, the study aims to explore relevant methodologies for developing diabetes technology and provide valuable information to developers by delineating essential phases of the design process. The literature search was focused on MEDLINE (PubMed), Web of Science, and Google Scholar for relevant studies. Keywords such as "type 1 diabetes," "adolescents," "kids," "mHealth," "children," and "coaching" were combined using Boolean operators. The inclusion criteria were open access, English-language papers published between 2012 and 2023 focusing on patients younger than 18 years and aligned with our research goal. The exclusion criteria included irrelevant topics and papers older than 18 years. By applying the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) method, 2080 studies were recognized, and after selection, 33 papers were agreed upon between the researchers. Four primary categories were defined: types of IT, methodology identification, purpose identification, and feature determination. Among these, mobile health (mHealth) apps emerged as the predominant type of information, garnering 27 mentions. In particular, user-centered design was identified as the most prevalent methodology, cited 22 times. The primary purpose of self-monitoring blood glucose values was mentioned 20 times, while patient education was the highest among common characteristics, with 23 mentions. Based on our research, we advocate for developers to focus on creating an mHealth app that integrates gamification techniques to develop innovative diabetes management solutions. This app should include vital functionalities such as blood glucose monitoring, strategies to improve hemoglobin A1c levels, carbohydrate tracking, and comprehensive educational materials for patients and caregivers. By prioritizing these features, developers can enhance the usability and effectiveness of the technology, thereby better supporting children or adolescents with diabetes in their daily management endeavors.

Effect of weekly high-dose vitamin D3 supplementation on the association between circulatory FGF-23 and A1c levels in people with vitamin D deficiency: A randomized controlled 10-week follow-up trial

Effect of weekly high-dose vitamin D3 supplementation on the association between circulatory FGF-23 and A1c levels in people with vitamin D deficiency: A randomized controlled 10-week follow-up trial

Efficacy and safety of Dapagliflozin and Glimepiride in combination with Metformin: Randomized clinical trial

Objective: To identify the effective treatment option between dapagliflozin-metformin and glimepiride-metformin combination in patients with type 2 diabetes who were inadequately controlled with metformin monotherapy. Study design and setting: The present study is randomized, conducted for 12 weeks at the National Medical center, Karachi, Pakistan. Methodology: The patients were divided into 2 treatment groups; group A was given dapagliflozin-metformin combination, while group B was given glimepiride-metformin combination. The efficacy endpoint of groups was estimated by hemoglobin A1c and fasting blood glucose levels at 0-, 6- and 12-week. While, safety endpoints were identified by analyzing liver function tests, lipid profile tests, renal function test, and urine analysis. The significant difference of data was analyzed by using statistical package of social sciences (SPSS) version 25. The parametric t-test and paired t-test were performed and considered p-value = 0.05 as statistical significant. Results: Baseline demographics, clinical features of diabetes, levels of liver enzymes, liver function test, renal function test, lipid profile, and urinalysis of randomized patients were similar in both treatment groups by showing p = 0.05. Followed by the initiation of the respective treatment, the baseline change of mean FBG and hemoglobin A1c levels with dapagliflozinmetformin combination was shown significantly reduce more compared to glimepiride-metformin combination (p = 0.05). Conclusion: Dapagliflozin-metformin combination therapy was superior and well-tolerated to regulate glycemic control as compare to glimepiride-metformin combination

Diabetes Control Status and Severity of Depression: Insights from NHANES 2005-2020.

Background/Objectives: Examining the risk of depression among patients with diabetes is crucial for understanding the mental health burden of this chronic condition. This study examined the likelihood of depression severity among participants in the National Health And Nutrition Examination Survey (NHANES) from 2005 to 2020, based on glycemic control status. Methods: Depression severity was categorized into three levels using the Patient Health Questionnaire-9 (PHQ-9), and glycemic control status was categorized into five groups based on prior diabetes diagnoses and hemoglobin A1c (HbA1c) levels. Using multinomial logistic regression models, the odds ratio (OR) and 95% confidence intervals (95%CIs) of various severities of depression by glycemic control status were calculated after comprehensive adjustments. Results: Out of 76,496 NHANES participants from 2005 to 2020, 37,037 individuals who met our inclusion criteria were analyzed. The likelihood of depression in individuals with prediabetes was not significantly different from those with normoglycemia. In contrast, participants with diabetes had a higher likelihood of having depression versus individuals with normoglycemia even when they kept their HbA1c within the normal range (lower than 5.7%). Among individuals with diabetes, those with HbA1c < 5.7% had a higher likelihood of mild depression (OR: 1.54, 95%CI: 1.02-2.34), while having HbA1c ≥ 10.0% was significantly associated with a greater likelihood of moderate to severe depression (OR: 1.53, 95%CI: 1.07-2.19) compared to those with HbA1c levels of 5.7-10.0%. Conclusions: Our findings highlight the need for a holistic approach to diabetes care that includes mental health considerations, especially for those who are at the extremes of the HbA1c spectrum.

Effects of Physical and Mind-body Exercise on Sleep Quality in Individuals With Diabetes Mellitus: A Systematic Review and Meta-analysis.

Physical and mind-body exercises represent distinct intervention strategies that may improve sleep quality by influencing physiological and psychological factors. Nevertheless, their effectiveness in individuals with diabetes is not well-established. This systematic review and meta-analysis aimed to examine the impacts of physical and mind-body exercise interventions on sleep quality in patients with diabetes mellitus. Six randomized controlled trials (RCTs) that met the inclusion criteria were identified from PubMed, CINAHL, Embase, Scopus, Web of Science, Cochrane, and Ovid-Medline Library. The effect size for sleep quality was calculated using the standardized mean difference (SMD) with a 95% confidence interval (CI), employing a random-effects model. Heterogeneity and publication bias were also examined, and subgroup, meta-regression, and sensitivity analyses were performed. Physical and mind-body exercise interventions significantly improved sleep quality, with an SMD of -1.040 (95% CI, -1.686 to -0.394). Subgroup analysis revealed significant differences with respect to the type of intervention (p=0.047), or its duration (p=0.282). Meta-regression analysis indicated that mean hemoglobin A1c level was the only factor to be significantly related to the effect size for sleep quality, demonstrating a negative association (p=0.033). The assessment of publication bias and the sensitivity analysis suggested that the findings were reliable and robust. Physical and mind-body exercises may serve as effective interventions for patients with diabetes mellitus who experience poor sleep quality. However, to substantiate these findings, additional rigorous RCTs with larger sample sizes, longer follow-up periods, and standardized interventions are required.

Combined Diabetes Education/Skills Training and Social Needs Resolution Intervention for Older African Americans with Poorly Controlled Type 2 Diabetes (DM Social Needs): Study Protocol for a Randomized Controlled Trial.

Approximately 11.3% of the US population has diabetes. The burden of diabetes is higher in older adults and African Americans (AAs), such that 40% of adults aged 50 years and older have diabetes; African Americans are 60% more likely to be diagnosed with diabetes compared to non-Hispanic Whites (NHWs). Structural racism has resulted in fewer economic and educational opportunities for AAs, higher social risks, and unmet basic needs, which result in financial instability, housing instability, food insecurity, and a lack of transportation compared to NHWs. The presence of these unmet basic needs is a driver of poor adherence to diabetes self-management in older AAs. To test the preliminary efficacy of a nurse case-manager, telephone-delivered intervention that provides foundational diabetes self-management education and skills training, while also addressing and resolving the unmet social needs of older AAs with poorly controlled type 2 diabetes mellitus (T2DM). The primary hypothesis is that older AAs with T2DM randomized to the DM Social Needs intervention will have significantly lower hemoglobin A1C (HbA1C), blood pressure, and LDL levels compared to the usual care arm at 6 months post randomization. This is a three-year prospective, randomized clinical trial that will enroll 100 AAs aged 50 and older with type 2 diabetes (T2DM) and HbA1C ≥ 8% into one of the following two groups: (1) a nurse case-manager, telephone-delivered intervention that provides foundational diabetes self-management education and skills training, but also addresses and resolves unmet social needs; or (2) an enhanced usual care group that will receive mailed diabetes education materials. Participants will be followed for 6 months to determine the effect of the intervention on HbA1C, blood pressure, and low-density lipoprotein (LDL) cholesterol levels. Baseline characteristics will be presented by study group, and within- and between-group changes in primary outcomes from baseline to 6 months will be reported. The results from this study will provide insights into the efficacy of a combined diabetes education and skills training and social needs resolution intervention for older African Americans with poorly controlled type 2 diabetes and will inform strategies to improve diabetes outcomes for this vulnerable population.

8469 Endocrinologists Underutilize Virtual Care Services Resulting in Suboptimal Clinical and Financial Outcomes

Abstract Disclosure: D. Terry: Employee; Self; Valendo Health. Less than 150,000 Medicare patients with diabetes (PWD) receive billable telehealth and remote monitoring services, even though over 12 million PWDs are eligible for these services. This is a missed quality opportunity, as studies show that PWDs who receive these services experience reductions in A1C levels and improvements in TIR. It is also a missed financial opportunity for Endocrinologists, who are among the lowest paid specialists in the US. The economics of Endocrinology are important, because inadequate compensation is leading to access constraints when the diabetes population is growing, and care complexity is increasing. We analyzed billed virtual health claims for every Medicare PWD in 2022. The types of services we examined included: Chronic Care Management (CCM &amp; PCM), Continuous Glucose Monitoring (CGM &amp; RPM), Medical Nutrition Therapy (MNT), and Diabetes Self-Management Training (DSMT). When we looked by Endocrinologist by virtual care service type, we found the following levels of service delivery for Endocrinologists at the median levels of utilization:4.8% of eligible PWDs received remote Continuous Glucose Monitoring support.4.2% received virtual Chronic Care Management services.6.2% received virtual Diabetes Self-Management Support.&amp;lt;1% received Medical Nutrition Therapy This is clearly a missed clinical quality opportunity as a study published in JAMA in October 2023, Comprehensive Telehealth Model to Support Diabetes Self-Management, reported the following improvements for PWDs who received virtual care for 6 months:Mean change in A1C levels: Type 1: -0.6%; Type 2: -1.0%Mean TIR Improvement: Type 1: 16%; Type 2: 18% It is also a missed financial opportunity for Endocrinology practices. Each patient with diabetes is potentially eligible for $100 or more of virtual care services per month. We’ve looked at every Endocrinology practice in the US and many are missing out on over a million dollars of annual revenue opportunity. This is important as Endocrinology organizations everywhere, independent and hospital based, are struggling to retain the doctors &amp; staff necessary to provide adequate access to care - leading to months of wait time to see an Endocrinologist. The prevalence of diabetes is growing significantly, while Endocrinologist capacity is shrinking. Value added and billable virtual care services create new opportunities for Endocrinologist to generate the revenue necessary to increase clinical capacity and improve access by creating diverse clinical teams led by Endocrinologists and supported by Diabetes Educators, Dietitians, and others with expertise in diabetes who can care for many more PWDs. Creating virtual care capabilities is also an early step in moving Endocrinology into Value-Based Care arrangements that reward providers for improving care and reducing costs rather than for generating more visits. Presentation: 6/1/2024

12524 Predictive Factors For Type 2 Diabetes Remission: Insights From A Digital Twin Intervention Program At 18 Months

Abstract Disclosure: P. Shamanna: None. M. Dharmalingam: None. A. Vadavi: None. A. Keshavamurthy: None. S. Bhonsley: None. M. Thajudeen: None. A. Balasubramanian: None. S.R. Joshi: None. Background and aims: Digital twin (DT) platform uses Artificial Intelligence (AI) and Internet of Things, to integrate multi-dimensional data for precision nutrition and health recommendations via the mobile app. Remission was defined as A1C levels less than 6.5% without medication for over 3 months. Evidence suggests that remission is more likely in individuals with early type 2 diabetes (T2D) who are not using insulin therapy and who can engage in significant weight loss. We evaluated the predictive value of baseline parameters on T2D remission, including duration of diabetes, HbA1c levels, diabetic medications as drug count, and CGM metrics, with the objective to improvise the patient selection strategies for remission Methods We analyzed T2D patients (n=209) who completed 18 months of digital twin intervention. Potential predictors were examined by logistic regression analyses, with model performance evaluated by accuracy, precision, recall, and Area under the Receiver Operating Characteristic Curve (AUC-ROC) metrics. Results The model achieved an accuracy of 78.57%, precision of 79.41%, recall of 93.10%, and AUC-ROC of 0.745. Significant inverse associations with remission were observed for the duration of diabetes (OR: 0.74), baseline HbA1c (OR: 0.76), and the number of anti-diabetic medications as oral drugs (OR: 0.77), indicating decreased odds of remission with increasing values. Conversely, positive associations were found for Time Below Range 2 at baseline (OR: 1.22) and HOMA2IR at baseline (OR: 1.24), suggesting increased odds of remission with higher values in these metrics. We describe the Receiver Operating Characteristic (ROC) curve for the diabetes remission prediction model, with the area under the curve (AUC) indicating the model's discriminatory ability. The duration of diabetes emerged as the most significant negative predictor, followed by baseline HbA1c and the number of diabetic drugs, while counterintuitive findings like the positive association of baseline HOMA2IR with remission suggest areas for further investigation. Conclusion We identified baseline parameters significantly influencing the likelihood of T2D remission in people undergoing digital twin intervention. The odds ratios indicate the effect sizes of these predictors, highlighting the importance of personalized, data-driven treatment approaches that potentially enhance remission outcomes. Further validation of these findings in larger external cohorts would be useful. Presentation: 6/1/2024

6828 Exploring Metabolomic Clues in Diabetic Retinopathy

Abstract Disclosure: M.W. Simonson: None. Y. Li: None. J.J. McAnany: None. B. Prasad: None. E.C. Hanlon: None. S. Pannain: None. B.T. Layden: None. E. Van Cauter: None. J.C. Park: None. S.J. Crowley: None. F.Y. Chau: None. K.K. Danielson: None. H. Chen: None. G.E. Chlipala: None. C. Martinez: None. S. Reutrakul: Speaker; Self; Eli Lilly &amp; Company. Background: Diabetic retinopathy (DR) is a common microvascular complication of diabetes. Metabolomics offers the possibility for novel biomarker discovery. The purpose of this study was to determine metabolomic differences that characterized patients with versus without DR. Methods: A total of 62 serum samples were collected from 36 type 2 diabetes (T2D) patients with DR and 26 T2D patients without DR, and analyzed via UPLC-MS. The metabolite data were normalized using median normalization. The differential expression of metabolites was compared among the groups using the limma package in R. The covariates (age, sex, BMI and sleep apnea severity) were accounted for by using a generalized linear model fitted to the data. Significantly different metabolites were filtered by an absolute log2 Fold Change (FC) of 1.5 or greater and Q values &amp;lt; 0.05. Results: Mean (SD) age for DR and no-DR group was 55 (±5.9) versus 54 (±6.7) years, while BMI was 33 (±5.8) versus 33 (±6.3) kg/m2 respectively. Both DR and no-DR groups were 58% female. A1C levels in DR group was marginally higher than in no-DR group (p=0.09). There were significant differences in metabolomic changes between DR versus no-DR, with 166 total differential metabolites after adjusting for covariates and filtering by FC. Notable metabolites included those involved in fatty acid metabolism, acyl carnitines, prostaglandins, and phospholipids. There was an overall upregulation of serum acyl carnitines in DR as compared to no-DR, including 2,6 dimethylheptanoyl carnitine (FC = 3.0) and cis-5-Tetradecenoylcarnitine (FC = 2.0). Additionally, there was a decrease in long chain fatty acids in DR as compared to no-DR, which included 6-hydroxypentadecanedioic acid (FC = -6.6), 10,16-dihydroxy-palmitic acid (FC = -6.0), and tetracosatetraenoyl CoA (FC = -6.1). The 11-beta prostaglandin F2 (11-PGF2) was increased in DR (FC = 1.9). Circulating phospholipids including lysophosphatidylcholine (22:2) (lysoPC) (FC = 1.8) and phosphatidylcholine (24:1/24:1) (PC) (FC = 5.9) were also significantly dysregulated. Conclusions: We identified a subset of metabolites that discriminate T2D patients with or without DR. The changes in acyl carnitines and long chain fatty acids may reflect mitochondrial dysfunction in DR. The presence of certain prostaglandins highlights the inflammatory environment which may facilitate DR progression. Increases in phospholipids such as lysoPC suggest an atherogenic state and higher LDL oxidation, while increases in PC may indicate altered lipogenesis in DR. These findings may serve as new potential serum biomarkers to promote efficient preventive care and provide mechanistic insight into understanding DR pathophysiology. Presentation: 6/2/2024

7093 Atherogenic Index of Plasma Is Strongly Correlated With Cardiovascular Disease Independent of LDL level in the US Population

Abstract Disclosure: H. Ayesh: None. K.D. Niswender: None. B.G. Carranza Leon: None. Introduction: Cardiovascular disease (CVD) poses a global health challenge, prompting exploration of risk factors. The Atherogenic Index of Plasma (AIP), calculated as the readily available TG/HDL-C ratio, stands out as a promising avenue for investigation. Previous studies have reported an independent association between AIP and cardiovascular disease across diverse populations. Despite this recognized significance, there exists a gap in understanding its relevance in the US. This research aims to bridge this gap by examining the AIP-CVD relationship within the US population, utilizing data from the National Health and Nutrition Examination Survey (NHANES). Methods: The study included 4,784 NHANES subjects, with AIP values calculated using the established formula. The outcome was assessed using a combined variable (stroke, myocardial infarction, and CAD). Statistical analysis employed logistic regression to evaluate the AIP-CVD relationship, controlling for age, BMI, hemoglobin A1c, blood pressure, smoking, and LDL levels. Results/Discussion: We observed a significant correlation between AIP and CVD (odds ratio: 1.77, P = 0.026, 95% CI: 1.07-2.94), which persisted after controlling for common risk factors, including HbA1c, BMI, blood pressure, smoking, and LDL levels. Importantly, our findings highlighted the independence of this association from LDL levels—a pivotal observation with implications for healthcare strategies. Our study suggests that even with optimized LDL levels, AIP maintains an independent association with CVD. Existing literature supports the notion that AIP levels are strongly correlated with small dense LDL and remnant cholesterol levels. The pragmatic utility of AIP as a cardiovascular risk marker is evident due to the impracticality and costliness of testing for small dense LDL and remnant cholesterol. Given AIP is based on routine lipid profiles, our data underscores the potential integration of AIP into clinical practice, streamlining risk assessment. As we delve into our findings, the optimization of cardiovascular risk beyond LDL levels emerges as a tangible goal, with AIP emerging as a valuable tool. Larger studies are needed to validate and generalize these findings in the US population. Presentation: 6/2/2024

12395 Continuous Glucose Monitoring In Pseudohypoparathyroidism Type 1a

Abstract Disclosure: J. Tamaroff: None. A.E. Lee: None. A.H. Shoemaker: None. Background: Pseudohypoparathyroidism type 1A (PHP1A), due to heterozygous mutations in GNAS, is a rare disorder that leads to multi-hormone resistance, cognitive impairment, and early-onset obesity. Individuals with PHP1A have dysglycemia on oral glucose tolerance tests and increased rates of type 2 diabetes (T2DM). Individuals with rare diseases, like PHP1A, may travel significant distances for specialized clinical or research care. Wearable technology may alleviate barriers and provide useful information for clinical care or for use as potential biomarkers. The objective of this study is to evaluate glycemia in individuals with PHP1A and feasibility of utilizing continuous glucose monitors (CGMs) in this population. Methods: Observational study of individuals with PHP1A (3R01DK118407-03S1). CGMs (Dexcom Pro, Dexcom Inc, San Diego, CA) were placed on participants’ abdomens, typically by a family member, over secure-video call with study staff. CGMs collected data every 5 minutes for up to 10 days. Results: Seven participants (all female) with PHP1A without a diagnosis of diabetes had available data. Median age was 17 years (IQR: 14, 19; range: 8-23). Body mass index (BMI) categories (by percent of the 95th percentile for those under 18 years and BMI for adults) spanned from overweight to class 3 obesity. In terms of feasibility, 1 individual had to replace a CGM sensor due to an upcoming MRI and 1 individual had a “sensor failure” of unclear etiology. Both were able to place new CGMs. Individuals participated across 5 states in the United States. Median length of wear was 9.8 days (IQR 8.6, 9.9). Participants had a median average glucose of 104mg/dL (IQR 102, 111) and COV of 16% (15, 21). Percent of glucose &amp;gt; 140mg/dL was 5.0% (IQR: 1.8, 10.9; range:1.2-19.4%). One individual had 3.2% of glucose values ≥ 200mg/dL despite a normal hemoglobin A1c (HbA1c) level (5.5%). This level of hyperglycemia is qualitatively higher than published CGM data in healthy individuals. One study found individuals (6-24 years of age) had median percent of glucose values over 140mg/dL ranging from 1.2 to 2.4% with IQR values ranging from 0.3 to 4.4%, based on age categories.1Conclusions: In females with PHP1A, with overweight or obesity, CGM placement at home is a feasible way to collect real-world data. Participants with rare diseases often must travel for clinical and research care and CGMs may provide insight into glycemia without requiring an in-person visit. This “real-world” data mirrors research data reporting glycemia with normal HbA1c levels. The rate of hyperglycemia is higher than expected in some individuals with PHP1A though more data is needed. Ongoing studies will evaluate matched control participants and assess drivers of glycemia including inactivity and decreased sleep duration, as measured by actigraphy.

6687 Indicators of Diabetes Management: Predicting Unplanned Healthcare Utilization and Mortality in a Suburban Integrated Delivery Network

Abstract Disclosure: K.M. Barton: None. J.Y. Yip: None. K.C. Geckeler: None. A. Popelka: None. D.J. Ramsey: None. Purpose: To explore whether patients with diabetes mellitus (DM) who met Comprehensive Diabetes Care Healthcare Effectiveness Data and Information Set (HEDIS) metrics had a reduced likelihood of experiencing unplanned emergency department (ED) visits, hospitalizations, or mortality. Introduction: The prevalence of DM among U.S. adults is approximately 15% and continues to rise. To enhance care for individuals with DM, Comprehensive Diabetes Care HEDIS quality measures have been established. These measures encompass criteria such as blood pressure control, hemoglobin A1c (HbA1c) levels, and the completion of an annual eye examination. However, the connection of these metrics to health outcomes remains insufficiently studied. Methods: This study comprised a retrospective, cross-sectional exploratory analysis of established patients aged 18 years or older with DM receiving primary care within a suburban integrated delivery network (IDN). Multivariate logistic regression was used to analyze patient characteristics, including demographics, sociomedical factors, and biometrics. Outcome variables encompassed one or more unplanned ED visits (including urgent care), one or more unplanned hospitalizations, or mortality within the one-year study period. Results: Out of 28,929 patients with DM, 5293 (18.3%) had ≥1 ED visit, 3725 (12.9%) had ≥1 hospital admission, and 614 (2.1%) died during 2022. After controlling for available demographic and sociomedical factors, patients with poor HbA1c control (considered HbA1c &amp;gt; 9.0) in the year prior were more likely to experience an ED visit in the study year (adjusted odds ratio [aOR] = 1.292, 95% CI, 1.121-1.489, p &amp;lt; 0.001). Patients who achieved HbA1c control (considered HbA1c &amp;lt; 8.0) in the year prior were less likely to experience an ED visit (aOR = 0.845, 95% CI, 0.763-0.936, p = 0.001) and less likely to experience a hospitalization in the study year (aOR = 0.878, 95% CI, 0.779-0.989, p = 0.032). Patients who completed an eye exam in the year prior were less likely to experience a hospitalization (aOR = 0.913, 95% CI, 0.847-0.984, p = 0.017) or die (aOR = 0.694, 95% CI, 0.579-0.831, p &amp;lt; 0.001) in the study year. Finally, patients who completed microalbumin testing in the year prior were less likely to experience an ED visit (aOR = 0.902, 95% CI, 0.84-0.968, p = 0.004), or die (aOR = 0.464, 95% CI, 0.389-0.554, p &amp;lt; 0.001). Conclusion: Achieving HbA1c control in the previous year is linked to decreased likelihood of experiencing an unplanned ED visit or hospitalization. An eye exam in the year prior was associated with decreased likelihood of hospitalization or death. Further research into interventions aimed at enhancing DM management and reducing associated complications may have potential to enhance patient health outcomes while reducing health care costs. Presentation: 6/3/2024

12542 Results Of The Foresight Trial Support The Efficacy And Safety Of Once-weekly Lonapegsomatropin In Adults With Growth Hormone Deficiency (ghd)

Abstract Disclosure: B.M. Biller: Consulting Fee; Self; HRA Pharmaceuticals, Novartis Pharmaceuticals, Sparrow, Strongbridge Biopharma. Grant Recipient; Self; Strongbridge Biopharma. A. Gilis-Januszewska: Speaker; Self; Ipsen, Novartis Pharmaceuticals, Novo Nordisk, Recordati, Teva Pharmaceutical Industries Ltd.. M. Doknic: None. A.M. Pico: None. M. Fleseriu: Consulting Fee; Self; Ascendis, GlaxoSmithKline, Johnson &amp;Johnson, Karyopharm, Novo Nordisk, Pfizer, Inc., Pharmacosmos. Research Investigator; Self; Ascendis. G. Raverot: None. A.M. Isidori: None. Y. Takahashi: None. J.M. Garcia: None. J.M. Silverstein: None. I. Bancos: None. E. Huang: Employee; Self; Ascendis Pharma, Inc. J. Kang: Employee; Self; Ascendis Pharma, Inc. A.S. Komirenko: Employee; Self; Ascendis Pharma, Inc. L. Domrzalski: Employee; Self; Ascendis Pharma, Inc. A. Shu: Employee; Self; Ascendis Pharma, Inc. K. Yuen: Advisory Board Member; Self; Amryt, Ascendis, Corcept, Crinetics, Novo Nordisk, Recordati, Strongbridge, Xeris. Grant Recipient; Self; Amryt, Ascendis, Corcept, Crinetics. Speaker; Self; Corcept, Novo Nordisk, Recordati. Background: Adult GHD (aGHD) is characterized by metabolic abnormalities due to insufficient growth hormone (GH) production. Lonapegsomatropin was designed to provide sustained release of unmodified somatropin, with the identical amino acid sequence as endogenous GH, and once-weekly injection reduces the burden of daily GH replacement therapy. MethodsForesiGHt was a randomized, parallel-3-arm, placebo(PL)-controlled (double-blind) and active-controlled (open-label) trial designed to establish the efficacy and safety of lonapegsomatropin in aGHD. It evaluated 259 adults with GHD across 21 countries who were GH treatment-naïve or not treated with GH in the prior year, randomized 1:1:1 to receive lonapegsomatropin, once-weekly PL, or daily somatropin (dGH). Fixed dosing was based on age and oral estrogen intake, and designed to be comparable across lonapegsomatropin and dGH arms. Following a 12-week (w) titration period to target maintenance dose, fixed doses were administered for 26w. ResultsBaseline (BL) characteristics were similar between arms. Lonapegsomatropin demonstrated superiority on the primary efficacy endpoint of change from BL in trunk percent fat at Week 38 vs PL (lonapegsomatropin -1.7% vs PL 0.4%, LS mean difference -2.0%, p &amp;lt; 0.0001) and on the key secondary efficacy endpoints of change from BL in total body lean mass (lonapegsomatropin 1.6 kg vs PL -0.1 kg, LS mean difference 1.7 kg, p &amp;lt; 0.0001) and change from BL in trunk fat mass (lonapegsomatropin -0.5 kg vs PL 0.2 kg, LS mean difference -0.7 kg, p = 0.0053). Mean total exposure and maintenance doses were similar for lonapegsomatropin and dGH arms, with larger changes from BL in average IGF-I SDS mean at Week 38 in the lonapegsomatropin arm (1.4) vs dGH arm (0.5). To assess outcomes at comparable weekly IGF-I exposure, a post-hoc analysis was performed in a subset of participants with average IGF-I SDS ≤1.75 SDS at Week 38. Mean IGF-I SDS for these subsets were similar (lonapegsomatropin -0.1, dGH -0.5), and comparable effects in fat and lean tissue compartments were demonstrated (change from BL in trunk percent fat mean -2.4% and -2.6% respectively; change from BL in total body lean mass mean 1.7 kg and 1.4 kg respectively). In the safety population, the incidence of severe AEs was low (lonapegsomatropin, 3.4%; placebo, 1.2%; dGH, 2.3%) and the incidence of treatment-related AEs was similar (lonapegsomatropin 24.7%, dGH 22.1%). Injection site reaction incidence was low and similar for lonapegsomatropin (4.5%), dGH (5.8%) and placebo (4.8%), and A1c levels remained stable in all treatment arms. ConclusionsThe results of the foresiGHt trial indicate that lonapegsomatropin is a safe, efficacious, and tolerable replacement for endogenous GH. Once-weekly dosing may be impactful for adults with GHD who typically manage multiple other medical therapies. Presentation: 6/3/2024

8455 Denosumab Is Associated With Decreased Mortality Compared To Zoledronic Acid In Diabetic Osteoporotic Patients: A Population-Based Cohort Study

Abstract Disclosure: V. Rouach: Consulting Fee; Self; Amgen Inc. H. Gortler: None. Y. Greenman: None. C. Gabriel: None. G. inbalL: None. Background: Anti-resorptive therapies are the mainstay of osteoporosis management, but evidence of their efficacy in the diabetic population is limited and comparison between treatments is lacking. A retrospective analysis, presented at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting, suggests that denosumab leads to greater reduction in fracture risk than zoledronic acid among treatment-naive postmenopausal women with osteoporosis. However, a comparative study recently published suggests higher mortality with denosumab versus oral bisphosphonates. Aim: To assess the association between zoledronic acid or denosumab and the risk of major osteoporotic fracture and mortality in osteoporotic patients with diabetes type 2. Methods: The study population was identified by electronic records of a diabetes registry cross-linked with an osteoporosis registry of a large provider healthcare organization in Israel. Index date was at osteoporosis registry entry. Demographics, Comorbidity Index (CCI), diabetes complications, bone mineral density (BMD) T-scores, hemoglobin A1c levels, eGFR, purchase of statins, and anti-resorptive agents were collected. Propensity score matching was performed. Kaplan-Meier curves were generated to assess the time to outcomes. Multivariable Cox's proportional hazards survival model was performed. Results: A total of 27503 diabetic osteoporotic patients were identified, 13343 (48%) patients initiated treatment; 12214 (91.5%) started an oral bisphosphonate, 627 (4.7%) zoledronic acid and 502 (3.7%) denosumab. The median follow-up was 8.9 years. The denosumab treated patients were older (75.7 vs 71.9, p&amp;lt;0.01), had longer diabetes duration (8.4 vs 7.2, p&amp;lt;0.01), were more frequently treated with insulin (29.7 vs 23.9, p=0.02) and had a lower eGFR (59.4 vs 75.3, p&amp;lt;0.01). Male/Female ratio, BMI, CCI, smoking status, alcohol consumption, Hip BMD, HbA1c levels, microvascular complications, hypoglycemic events and statins prescriptions were similar. After propensity weighting, we observed a significant reduced risk of death among the denosumab treated patients (RR=0.72 [0.58-0.91]) without a significant difference in the risk of fracture (RR=0.9 [0.82-1.12]). Conclusions: In this cohort of diabetic osteoporotic patients, denosumab was associated with a significantly reduced mortality compared to zoledronic acid, without a significant difference in the risk of fractures. The effect of denosumab on mortality is yet to be explored. Presentation: 6/1/2024

7305 Pheochromocytoma Presenting With Resistant Hyperglycemia

Abstract Disclosure: M. Economou: None. A. Devine: None. Background: Pheochromocytoma is a rare catecholamine producing tumor arising from the adrenal gland. Impaired glucose tolerance is a well-recognized hormonal and metabolic manifestation of pheochromocytoma caused by catecholamine excess [1]. Insulin resistance requiring very high doses of insulin in association with pheochromocytoma is, however, rare. Here we report a case of pheochromocytoma in a woman with diabetes mellitus that proved difficult to control despite high-dose insulin therapy. Case presentation: A 72-year-old woman with a longstanding history of type 2 diabetes mellitus, uncontrolled hypertension, hyperlipidemia and CVA presented to the hospital after she was found to have a hemoglobin of 7.0 ng/mL on routine labs. Notably, over the past 4 years, her insulin requirement gradually increased from 20 units/day to 50 units/day despite an A1c level of 6.1%. On presentation, our patient was hypertensive to 170/90 with limited response to multiple antihypertensive medications. Additionally, her glucose was severely uncontrolled, fluctuating between 200-500 mg/dL. Within days, the patient’s total daily insulin requirement increased tremendously to as much as 300 units/day. As part of her anemia workup, she underwent a contrast-enhanced CT abdomen &amp; pelvis which identified a left adrenal mass measuring 2.2 x 2.8 x 2.9 cm. Further evaluation with MRI confirmed an adrenal mass suspicious for pheochromocytoma. Evaluation of plasma hormone levels revealed an elevated normetanephrine level of 7.10 nmol/L (normal: less than 0.89 nmol/L). Furthermore, the 24-h urinary normetanephrine level and chromogranin A levels were elevated to 145 mcg/day and 1203 ng/mL, respectively. Initial treatment with alpha and beta blockade improved blood pressure but glucose levels remained persistently elevated. The patient underwent left laparoscopic adrenalectomy and pathology revealed pheochromocytoma, measuring, 3.2 cm in diameter, with stains positive for CD56, synaptophysin and chromogranin. Surgical resection margins were negative for tumor. Postoperatively, insulin requirements returned to roughly that of her baseline, 40 units/day. Conclusion: Impaired glucose tolerance is a known phenomenon associated with pheochromocytoma. Despite this, it is unusual to see an insulin requirement rise as abruptly and drastically as seen in this case. Our patient, with relatively controlled diabetes had an enormous increase in her insulin requirement during her hospital course as evidenced by her insulin regimen which increased sixfold. This case highlights the importance of maintaining a high degree of suspicion for pheochromocytoma in patients with a sudden rise in insulin requirement and uncontrolled hypertension. Reference: (1) Ronen JA, Gavin M, Ruppert MD, Peiris AN. Glycemic Disturbances in Pheochromocytoma and Paraganglioma. Cureus. 2019 Apr 27;11(4): e4551. Presentation: 6/3/2024

9236 Denosumab Is Associated With Decreased Mortality Compared To Zoledronic Acid In Diabetic Osteoporotic Patients: A Population-Based Cohort Study

Abstract Disclosure: V. Rouach: Consulting Fee; Self; Amgen Inc. H. Gortler: None. Y. Greenman: None. C. Gabriel: None. G. inbalL: None. Background: Anti-resorptive therapies are the mainstay of osteoporosis management, but evidence of their efficacy in the diabetic population is limited and comparison between treatments is lacking. A retrospective analysis, presented at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting, suggests that denosumab leads to greater reduction in fracture risk than zoledronic acid among treatment-naive postmenopausal women with osteoporosis. However, a comparative study recently published suggests higher mortality with denosumab versus oral bisphosphonates. Aim: To assess the association between zoledronic acid or denosumab and the risk of major osteoporotic fracture and mortality in osteoporotic patients with diabetes type 2. Methods: The study population was identified by electronic records of a diabetes registry cross-linked with an osteoporosis registry of a large provider healthcare organization in Israel. Index date was at osteoporosis registry entry. Demographics, Comorbidity Index (CCI), diabetes complications, bone mineral density (BMD) T-scores, hemoglobin A1c levels, eGFR, purchase of statins, and anti-resorptive agents were collected. Propensity score matching was performed. Kaplan-Meier curves were generated to assess the time to outcomes. Multivariable Cox's proportional hazards survival model was performed. Results: A total of 27503 diabetic osteoporotic patients were identified, 13343 (48%) patients initiated treatment; 12214 (91.5%) started an oral bisphosphonate, 627 (4.7%) zoledronic acid and 502 (3.7%) denosumab. The median follow-up was 8.9 years. The denosumab treated patients were older (75.7 vs 71.9, p&amp;lt;0.01), had longer diabetes duration (8.4 vs 7.2, p&amp;lt;0.01), were more frequently treated with insulin (29.7 vs 23.9, p=0.02) and had a lower eGFR (59.4 vs 75.3, p&amp;lt;0.01). Male/Female ratio, BMI, CCI, smoking status, alcohol consumption, Hip BMD, HbA1c levels, microvascular complications, hypoglycemic events and statins prescriptions were similar. After propensity weighting, we observed a significant reduced risk of death among the denosumab treated patients (RR=0.72 [0.58-0.91]) without a significant difference in the risk of fracture (RR=0.9 [0.82-1.12]). Conclusions: In this cohort of diabetic osteoporotic patients, denosumab was associated with a significantly reduced mortality compared to zoledronic acid, without a significant difference in the risk of fractures. The effect of denosumab on mortality is yet to be explored. Presentation: 6/1/2024