bluuebunny/crossref_metadata_2025 huggingface dataset:
536-P: Resilience in Real Time: Parents of Youth with Type 1 Diabetes (T1D) Summer 2020 Psychosocial Experiences
Authors: JONES JASMINE N. , CARREON SAMANTHA A. , ROONEY KELLYANN , WANG CHRISTINE H. , TULLY CARRIE , MONAGHAN MAUREEN , STREISAND RANDI , HILLIARD MARISA E.
Published: June 2021

Objective: The COVID-19 pandemic disproportionately impacts parents, people with health risks like diabetes, and those with fewer financial resources. Minorities face particularly negative outcomes of the pandemic, and racial tensions after George Floyd’s murder may have worsened effects. We examined group differences by race/ethnicity and socio-economic status (SES) in depressive symptoms and protective factors in parents of children with T1D in summer 2020.

Methods: Participants were n=100 parents (98% mothers) of youth with T1D (60% female, M age=6.7±1.6 yrs, M T1D duration = 2.9±.5 yrs), who completed a behavioral RCT ≥6 months prior. In July/July 2020, parents self-reported on awareness of how to obtain housing/financial/food resources (Protective Factor Survey Concrete Support [PFS-CS] subscale) and depressive symptoms (Center for Epidemiological Studies -Depression [CES-D]). Race/ethnicity (66% non-Hispanic white, 12% non-Hispanic Black, 11% Hispanic, 11% other) and health insurance (33% public, 67% private) were reported at RCT enrollment. We ran ANOVAs and Pearson correlations to compare CES-D and PFS-CS by demographic groups.

Results: PFS-CS scores differed significantly by race/ethnicity and insurance status, both p<.01. Hispanic (M=1.6±0.5) and non-Hispanic Black (M=1.6±0.6) parents had higher CS than non-Hispanic white parents (M = 1.3±0.3). Those with public insurance (M = 1.6±0.5) had higher CS than those with private insurance (M = 1.3±0.3). Higher CS correlated with lower CES-D, r = -.26, p = .05. CES-D did not differ across groups.

Conclusion: Racially/ethnically diverse and lower SES parents of children with T1D reported more knowledge about how to access useful resources. This may have buffered against elevated mood symptoms during co-occurring major societal and public health stressors in 2020. Highlighting sources of support and resilience may be a useful strategy in strength-based interventions for parents of children with T1D.

Disclosure

J. N. Jones: None. S. A. Carreon: None. K. Rooney: None. C. H. Wang: None. C. Tully: None. M. Monaghan: None. R. Streisand: None. M. E. Hilliard: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (1R01DK102561)
570-P: Impact of Psychosocial Factors, Self-Efficacy, Knowledge, and Nutrition Using 12-Week Courses on Diabetes Management for Veterans
Authors: FARRELL NANCY , SHAHEED JENNIFER S. , DAVIS JANEL , VALENCIA GEMARIAH , CLARK RALPH , COLELLA DANIEL J.
Published: June 2021

Background: Approximately 25% of U.S. veterans have diabetes and suffer from psychosocial complications. The Diabetes Empowerment Group (DEG), developed by Loma Linda VA Hospital’s Behavioral Medicine Service, is a 12-week interdisciplinary group to help veterans manage their diabetes. Curriculum included values assessment, SMART goal setting, stress management, problem solving, mindful eating and nutritional education.

Methods: Veterans attended their respective 12-week DEG group. Hemoglobin A1c levels were measured and participants completed QI measures at the beginning and end of their group cycles. Scores on QI measures were used to determine if group content impacted veterans’ HbA1c levels, diabetes-related psychosocial self-efficacy, knowledge, emotional distress, confidence to perform management behaviors and depressive symptoms. Paired sample t-tests compared pre- and post-group values.

Results: Eighty veterans completed lab work and QI measures. Significant mean differences were found between scores on pre- and post-treatment measures for A1c levels, depressive symptoms, diabetes knowledge, distress, psychosocial self-efficacy and confidence to manage their diabetes. Post-treatment scores were significantly lower than pre-treatment scores for A1C levels, depressive symptoms, and diabetes distress. Post-treatment scores were significantly higher than pre-treatment scores for diabetes knowledge, psychosocial self-efficacy, and confidence.

Conclusion: Findings expand on a previous QI study and demonstrate the efficacy of the DEG group at helping manage diabetes, reducing biopsychosocial complications and increasing knowledge. Future options for QI include evaluation of future programs (e.g., Diabetes Support Grp and DEG mobile app) to support current and alumni group members with maintenance of diabetes management skills learned.

Disclosure

N. Farrell: None. J. S. Shaheed: None. J. Davis: None. G. Valencia: None. R. Clark: None. D. J. Colella: None.
571-P: Motivation, Self-Efficacy, Social Support, and Patient Activation among Racially/Ethnically Diverse Adults with Prediabetes
Authors: RODRIGUEZ LUIS A. , THOMAS TAINAYAH , FINERTIE HOLLY , TURNER CASSIE D. , HEISLER MICHELE , SCHMITTDIEL JULIE
Published: June 2021

Background: Black, Latino, and Asian Americans experience higher diabetes incidence rates compared to White adults. According to self-determination theory, psychosocial factors such as autonomous motivation, self-efficacy, perceived social support and patient activation influence the likelihood of initiating and engaging in health behaviors that prevent diabetes. Whether these psychosocial factors differ by race/ethnicity among adults with prediabetes and if these may contribute to observed racial/ethnic disparities in diabetes incidence is unknown.

Methods: Using baseline survey data from a diabetes prevention intervention study at Kaiser Permanente Northern California and Michigan Medicine, we measured autonomous motivation and self-efficacy on a 1-7 scale, perceived social support on a 12-72 scale, and activation on a 0-100 scale. Multivariable linear regression models estimated mean racial/ethnic differences, adjusting for age, sex and clinic.

Results: Of 296 prediabetic adults, 40% were White, 37% Black, 10% Latino, and 6% Asian American. Mean autonomous motivation was high (6.6/7) and did not differ by race/ethnicity (all p-values >0.05). Self-efficacy was higher for Black vs. White adults (6.1 vs. 5.7; p-value < 0.05). Black and Latino adults had higher values of perceived social support compared to White adults, and Asian American adults had the lowest (all p-values < 0.05). Mean activation was higher in Asian American and Latino compared to White adults, but lower in Black adults (p-values < 0.05).

Conclusion: Autonomous motivation was high in adults with prediabetes, underscoring the opportunity to address diabetes prevention efforts at the population level. However, Asian American adults reporter lower social support and Black adults reported lower patient activation than other groups. Differences in these psychosocial factors should be considered when tailoring diabetes prevention efforts and outreach.

Disclosure

L. A. Rodriguez: None. T. Thomas: None. H. Finertie: None. C. D. Turner: None. M. Heisler: None. J. Schmittdiel: None.

Funding

Permanente Medical Group; National Institute of Diabetes and Digestive and Kidney Diseases (T32DK11668401)
582-P: Gestational Diabetes and Breastfeeding: Evidence from PRAMS
Authors: HEBERT LUCIANA E. , NIKOLAUS CASSANDRA J. , ZAMORA-KAPOOR ANNA , SINCLAIR KAIMI
Published: June 2021

Gestational diabetes (GD) disproportionately affects American Indian and Alaska Native (AI/AN) women, who are nearly twice as likely to experience GD as non-Hispanic White women. Despite the well-established benefits associated with breastfeeding, including reduction of risk of type 2 diabetes, women who develop GD are frequently less likely to breastfeed than women who do not develop GD. AI/AN women are less likely to initiate breastfeeding and breastfeed for a shorter duration compared to other women. No previous study has evaluated the potential link between GD and breastfeeding outcomes among AI/AN women. The purpose of this study was to examine the relationship between GD and breastfeeding among women of different ethnicities in four states using the Pregnancy Risk Assessment Monitoring Surveillance (PRAMS). We used data from Phase 8 (2016-2018) of PRAMS from Alaska, Oklahoma, South Dakota, and Washington. We used logistic regression to estimate factors associated with breastfeeding initiation for each group of women, conducted survival analysis using Kaplan Meier curves, and Cox proportional hazards regression to analyze duration of breastfeeding. Twelve percent of AI/AN and Hispanic women had GD in their most recent pregnancy, compared to less than 9 percent among non-Hispanic White and non-Hispanic Black women (p<0.0001). AI/AN women were the least likely to initiate breastfeeding compared to other women (85% vs. 88-93%, p<0.0001) and the least likely to be breastfeeding at the time of survey (51% vs. 57-69%, p<0.0001). While there was no association between GD and initiation of breastfeeding, women who had GD had a shorter duration of breastfeeding compared to women who did not have GD. GD significantly modifies the association between race/ethnicity and breastfeeding duration. Increasing support for AI/AN women with GD to initiate and continue breastfeeding may represent an effective and culturally appropriate intervention to improve maternal and child health outcomes and reduce disparities.

Disclosure

L. E. Hebert: None. C. J. Nikolaus: None. A. Zamora-kapoor: None. K. Sinclair: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (P30DK092923)
586-P: Characteristics Associated with A1C at 18-Months after Diagnosis in Young Children with Type 1 Diabetes
Authors: ENG JARED S. , ROONEY KELLYANN , HENDERSON CELIA , MARKS BRYNN E. , TULLY CARRIE , MONAGHAN MAUREEN , HILLIARD MARISA E. , STREISAND RANDI , WANG CHRISTINE H.
Published: June 2021

Introduction: The incidence of T1D in young children is increasing, yet the majority of children do not achieve glycemic targets, and little is known about predictors of A1c in young children. This study examines demographic predictors of A1c among young children through 18 months post-diagnosis.

Methods: Participants were 37 young children (age 1-6 years, Mage=4.53(1.64), MA1c at diagnosis= 10.47(1.93)) with T1D whose parents were randomized to the usual care condition of a multi-site behavioral intervention trial within 8 weeks of diagnosis. At baseline, parents self-reported on sociodemographic information, CGM use and depression symptoms; DKA status at diagnosis and A1c values at 18 months were obtained from medical records. Child A1c at 18-months post-diagnosis (MA1c= 8.05 (0.93)) was dichotomized into “below target” (≤7.5%; n=15; 40.5%) or “above target” (>7.5%; n=22; 59.5%).

Results: Family income (two-tailed Fisher’s exact test, p=.019), parent race/ethnicity (χ2(1, N=37)=8.97 p=.003), and child sex (χ2(1, N=37)=3.96, p=.047) were all significantly associated with 18-month A1c. Post hoc analyses using Bonferroni corrections indicated families with higher income, parents who identified as non-Hispanic white, and male children were more likely to be in the “below target” group compared to families with lower income, parents who identify as a racial/ethnic minority and female children, respectively. The 18-month A1c was not associated with baseline CGM use or parent depressive symptoms, nor DKA at diagnosis (p>.05).

Conclusions: There are limited prospective studies of early predictors of A1c in young children. Our results are consistent with findings regarding demographic correlates of A1c found in older children and highlight the importance of social determinants of health. Future research using larger samples should explore the role of additional potential correlates of later glycemic control.

Disclosure

J. S. Eng: None. K. Rooney: None. C. Henderson: None. B. E. Marks: None. C. Tully: None. M. Monaghan: None. M. E. Hilliard: None. R. Streisand: None. C. H. Wang: None.

Funding

National Institute of Diabetes and Digestive and Kidney Disease (R01DK102561)
59-OR: The Diabetes Garage: Using Automotive Maintenance Analogies to Engage Mexican-American Men to Participate in a Diabetes Self-Management and Education Program
Authors: CONCHA JEANNIE B. , SCHOBER GREGORY , PORTILLO DENISE N. , RUIZ ROSALBA F. , RAMOS REBECA , ROMERO RAQUEL L. , LOPEZ ARMANDO , WINKLER PAULA
Published: June 2021

Mexican-American (MA) men are three times more likely to have diabetes compared to non-Hispanic whites. Despite the availability of diabetes management programs, MA men are underrepresented. The CDC reports that woman (75%) disproportionately participate in diabetes programs compared to men (25%). MA men in particular, have less diabetes knowledge, are less likely to visit a diabetes specialist or adhere to treatments, and are more likely to have complications.

Purpose: The Diabetes Garage (DG) is designed to engage MA men in self-management behaviors, improve glycemic and physical health outcomes.

Methods: The DG was implemented 2 hours weekly/4 weeks and co-taught by CDCES and automotive technicians. Pre-posttests of self-management behaviors and physical indicators were collected at workshop 1 and at the end of workshop 4. Wilcoxon matched-pairs signed-rank tests were conducted to assess pre-post test differences in behavior (food portion/carbohydrate intake, physical activity) and paired t-tests were conducted to examine differences in health outcomes (i.e., A1c, BP, weight, waist).

Results: Data from 2018-2020 (N=74) indicate 77% retention rate. Statistically significant improvements were found in self-reported food portion (Z= -2.030, p <.05) and carbohydrate intake (Z= -2.787, p <.01). Statistically significant improvements were found in systolic BP (t=2.91, mean diff=9.47, p=.01) and improvements in diastolic BP (t=1.41, mean diff=8.18, p =.176). Satisfaction surveys show that men enjoyed the workshops: “The information, the presenters, the diabetes education was totally empowering ⋯ I am looking forward to better managing my diabetes and driving my human-mobile for a long-time...with good quality of life.”

Conclusion: Use of automotive maintenance analogies is a feasible approach for engaging men in diabetes management programs, self-management behaviors, and improving health indicators.

Disclosure

J. B. Concha: None. G. Schober: None. D. N. Portillo: None. R. F. Ruiz: None. R. Ramos: None. R. L. Romero: None. A. Lopez: None. P. Winkler: None.

Funding

Texas Department of State Health Services
594-P: Use of Connected Glucometer with Real-Time Feedback and Counseling for Glycemic Control in Patients with Diabetes in India: BeatO's Connected Diabetes Care Program
Authors: SABHARWAL MUDIT , MOHIT MINAL , KOLUKULA VAMSI K. , JANGID RUPALI , CHOPRA GAUTAM
Published: June 2021

Background: BeatO® offers connected diabetes care program including smartphone connected glucometer and mobile app with real time feedback and counselling support. This study aims to evaluate the effectiveness of BeatO's connected diabetes care program with real time contextualized feedback loop and certified diabetes educator (CDE) counselling on glycemic control of patients with diabetes in India.

Method: A retrospective data-based evaluation study was conducted on BeatO® cloud database. Medical records of patients with diabetes, digitally engaged between September 2019 to July 2020 and received at least one CDE counselling were evaluated. Intervention included SMBG using smartphone connected glucometer, real-time feedback, and contextualized counselling by CDE based on SMBG findings. Pre-counselling (BG values recorded for 30 days period before first counselling) and post counselling (BG values recorded between 15th to 45th day after last counselling) impact on glycemic control and in range BG values were assessed.

Results: Out of total 7514 diabetes patients, majority of them were aged >40 years (76%). Most of the patients had T2D (95%) followed by T1D (4.5%), GDM (0.3%), LADA (0.1%) and MODY (0.1%). A total of 10,667 counselling sessions were conducted out of which majority had one session (74%) followed by 2 (17%), 3 (5%), 4 (2%) and ≥5 (1%) sessions. Intervention was effective in significantly reducing mean BG values across fasting (by 9.5%), pre-prandial (9.3%), post prandial (8.9%) and random (6%) BG readings (p value <.05). Proportion of patients with in-range BG values post intervention increased by 9.6% (post prandial <180 mg/dL), 9.1% (random <200 mg/dL), 5.8% (fasting 80-130 mg/dL) and 3.3% (pre-prandial 80-130 mg/dL).

Conclusion: BeatO's smartphone connected SMBG with real time feedback, nudges, alerts and CDE counselling is effective in glycemic control in real world patients with diabetes.

Disclosure

M. Sabharwal: Employee; Self; Health Arx Technologies Pvt. Ltd. M. Mohit: Consultant; Self; Health Arx Technologies Pvt. Ltd. V. K. Kolukula: None. R. Jangid: None. G. Chopra: Employee; Spouse/Partner; Health Arx Technologies Private Limited, Other Relationship; Self; Health Arx Technologies Private Limited.
595-P: CGM Use in Ambulatory Insulin-Treated Patients following Hospital Discharge
Authors: RIZVI ALI A. , EBERLEIN CELESTE
Published: June 2021

Hospitalization is an opportunity for initiation and reevaluation of diabetes management. Many inpatients are either found to have new hyperglycemia or suboptimal glucose control, necessitating the initiation or titration of insulin. Blood glucose monitoring has traditionally been used with insulin therapy. Continuous glucose monitoring (CGM) of interstitial fluid has gained favor as an effective means to achieve this end. We studied the impact of early institution of CGM in the hospital and continuing post-discharge in insulin-treated patients over a 6-month time period. The initiative was shepherded by a newly-established academic endocrinology practice consisting of a diabetes specialist and a nurse clinician. Focused inpatient diabetes teaching, followed by formal outpatient education delivered by certified educators, was employed. 47 patients (31 males, 16 females; average age 63.3 years) were either begun or progressed to intensive insulin therapy (2-4 daily injections), coupled with CGM use (Freestyle Libre or Dexcom G6) within 2 weeks of discharge. Patients used blood glucose meter readings as needed. Downloaded CGM data with ambulatory glucose profile was reviewed for each patient proactively at least once a month. Patients were advised of changes in insulin/diabetes therapy by phone or electronic portal, and during telehealth and in-person office visits. The average time-in-range (TIR) increased from 59.6% to 60.9% (p= 0.5), while the average hemoglobin A1c decreased from an inpatient value of 9.8% to 7.4% (p<0.05) over a mean period of 6 months. The CGM continuation rate was close to 100%. We conclude that with availability of expertise and clinical support, CGM and its interactive technology offers a unique tool to improve glucose control and empower insulin-treated outpatients in the critical post-hospitalization time. It would be expected to result in better outcomes with regard to complications, readmission rates, and cost of care.

Disclosure

A. A. Rizvi: None. C. Eberlein: None.
6-OR: Psychological Comorbidities and Racial/Ethnic Disparities in Preventable Hospitalizations among Medicaid-Enrolled Adults with Type 2 Diabetes
Authors: LEE AARON A. , ZHANG YIQIAO , RAMACHANDRAN SUJITH
Published: June 2021

Background: Among adults with type 2 diabetes, racial and ethnic minorities have significantly higher rates of potentially preventable hospitalizations (PPH) compared to White non-Hispanic adults. Depression, anxiety, and stress-related disorders are associated with increased risk of diabetes related PPH. We examined the interaction of these risk factors among Medicaid enrollees.

Methods: This study used 2014 Medicaid claims data from 17 US states. The sample included 1,049,790 adults with type 2 diabetes. The outcome was >=1 diabetes related PPH, defined by the AHRQ Prevention Quality Diabetes Composite measure. Predictors were race/ethnicity and mental health diagnoses (PTSD, adjustment disorder, generalized anxiety disorder [GAD], phobic disorders, and depressive disorders). Logistic regression models examined the adjusted main-effects and interactions of both predictors on PPH, adjusting for clinical and demographic characteristics.

Results: Depression was associated with significantly greater odds of PPH (Adjusted Odds Ratio [AOR] = 1.50, 95%CI: 1.47, 1.60). PTSD (AOR = 0.81, 95%CI: 0.69, 0.96) and GAD (AOR = 0.79, 95%CI: 0.68, 0.92) were associated with lower odds of PPH. Black adults had significantly higher odds of PPH (AOR = 1.30, 95%CI: 1.26, 1.34) and Hispanic adults had significantly lower odds of PPH (AOR = 0.95, 95%CI: 0.91, 0.99) compared to White non-Hispanic adults. Depression increased odds of PPH among Black adults (AOR = 1.09, 95%CI: 1.03, 1.16) and decreased odds of PPH among Hispanic adults (AOR = 0.87, 95%CI: 0.79, 0.96) compared to White non-Hispanic adults.

Discussion: Of the psychological comorbidities examined, only depression was associated with increased risk of diabetes related PPH. Results suggest that depressive symptoms may exacerbate racial and ethnic disparities in PPH. Adults with PTSD or GAD diagnoses may have greater engagement with preventive healthcare and thus, lower risk of PPH.

Disclosure

A. A. Lee: None. Y. Zhang: None. S. Ramachandran: None.
610-P: Research on Consistency of Mass Spectrometry and Enzymatic Methods for Saliva 1,5-anhydroglucitol Measurement
Authors: BAO YUQIAN , JIAN CHAOHUI , ZHAO AIHUA , MA XIAOJING , LU WEI , ZHU WEI , WANG YUFEI , ZHOU JIAN
Published: June 2021

Objective: To evaluate the agreement of different measurement methods of saliva 1,5-anhydroglucitol (1,5-AG) in different glucose metabolism populations.

Methods: A total of 175 healthy volunteers (21–65 years, 58 males and 117 females) with normal glucose tolerance (NGT) and 80 diabetic patients (18–70 years, 44 males and 36 females) were enrolled from January 2018 to June 2019 and saliva was collected by saliva collection tube. Saliva 1,5-AG was measured using both enzymatic and mass spectrometry methods and serum 1,5-AG was determined by enzymatic method.

Results: In subjects with NGT, the serum and saliva 1,5-AG levels detected by enzymatic method were both significantly positively correlated with the saliva 1,5-AG levels detected by liquid chromatography-mass spectrometry (LC-MS) (r = 0.247 and 0.523, respectively, both P < 0.05). However, there was no significant correlation between saliva and serum 1,5-AG levels detected by enzymatic method (r =-0.074, P = 0.333). In diabetic patients, the serum and saliva 1,5-AG levels detected by enzymatic method were both significantly positively correlated with the saliva 1,5-AG levels detected by gas chromatography-mass spectrometry (GC-MS) (r = 0.284 and 0.423, respectively, both P < 0.05). There was no significant correlation between saliva and serum 1,5-AG levels detected by enzymatic method (r ='0.079, P = 0.487).

Conclusion: Both the serum and saliva 1,5-AG levels detected by enzymatic method have good agreement with saliva 1,5-AG levels detected by mass spectrometry method. The saliva and serum 1,5-AG levels detected by enzymatic method are not well correlated, so the enzymatic detection of saliva 1,5-AG needs further improvement for clinical practice.

Disclosure

Y. Bao: None. C. Jian: None. A. Zhao: None. X. Ma: None. W. Lu: None. W. Zhu: None. Y. Wang: None. J. Zhou: None.
614-P: Success of CME at Improving Knowledge of Clinical Use of Real-Time CGM
Authors: LARKIN AMY , SCHRAND JULIE , LE ANNE
Published: June 2021

We sought to determine if an online continuing medical education (CME) activity could improve knowledge and competence of diabetologists/endocrinologists (D/Es) and primary care physicians (PCPs) related to clinical use of rtCGM. The effect of an online, 15-minute, CME-certified summary of a satellite symposium was analyzed to determine efficacy. A repeated pairs pre-/post-assessment study design was used and chi-squared test (5% significance level, P <.05) assessed educational effect. Cramer's V was used to calculate the effect size (0.06-0.15 is a noticeable effect, 0.16-0.26 considerable, and >0.26 extensive). The activity posted June 22, 2020, and data were collected through October 14, 2020. Matched learner data indicate that overall, 19% of D/E learners' (N=234) and 26% of PCP learners' (N=241) responses improved from pre-to-post (both P<.001) with a considerable effect size of 0.164 and 0.205, respectively On a question-level: 15% of D/Es and 17% of PCPs improved at recognizing recent clinical trial data on the use of rtCGM in pregnant patients with T1D 24% of D/Es and 34% of PCPs improved at identifying appropriate TIR levels in patients with gestational diabetes Overall, 33% of D/Es and 46% of PCPs reported increased confidence in interpreting glucometric data from CGM device, for a total confidence shift of +11.4% and +23.3, respectively. Continued educational gaps: • 29% of both D/Es and PCPs did not recognize data on the use of rtCGM in pregnant T1D patients • 41% of D/Es and 49% of PCPs did not recognize appropriate TIR levels in gestational diabetes This study demonstrates the success of an online summary from a satellite symposium on improving knowledge and confidence of clinical use of rtCGM, with gaps identified for future education.

Disclosure

A. Larkin: None. J. Schrand: None. A. Le: None.

Funding

Dexcom, Inc.
627-P: Uncontrolled Hyperglycemia Predicts Ventilatory Support and Duration of Hospital Stay in People with Diabetes and COVID-19
Authors: CHAUDHURI SOUMYABRATA ROY , MAJUMDER ANIRBAN , SANYAL DEBMALYA , BISWAS AJOY , BHATTACHARJEE KINGSHUK
Published: June 2021

Background: Despite growing evidence that diabetes is associated with worse COVID-19 outcomes, there remains little information on inpatient glycemic response among individuals with diabetes and uncontrolled hyperglycemia hospitalized with the novel coronavirus SARS-CoV-2.

Methodology: This is a multicentric retrospective study aimed to explore the role of hyperglycaemia (uncontrolled HbA1c) in predicting length of hospital stay and ventilatory support in diabetic patients hospitalised for COVID-19. We excluded all patients with newly diagnosed diabetes within last 3 months and/or those who are only on lifestyle modification.

Results: A total of 133 patient records admitted to three tertiary care hospitals between 15/05/2020 to 15/11/2020 were analysed retrospectively. The 62 patients requiring ventilatory support had a significantly higher HbA1c (9.49±2.73%) as compared to those without ventilatory support (8.09±1.32%), p=0.002. Multiple logistic regression also indicated that the HbA1c was an independent risk factor for ventilatory support in DM patients with COVID-19 (Odds Ratio [OR] = 1.310, 95% confidence interval [CI]: 1.063-1.615), p=0.011. The odds of requiring ventilatory support is 35% lower in patients with good glycemic control (HbA1c<7.5%) vs. those with HbA1c≥7.5% (OR-0.65, 95%CI 0.32-0.88). The mean duration of hospital stay was 10.5±3.45 days. Multiple linear regression analysis revealed HbA1c to predict the duration of hospital stay, p=0.001. For every 1% increase in HbA1c, the length of hospital stay was found to increase by 0.461 days.

Conclusion: The present study demonstrated that a high level of HbA1c was an independent risk factor for ventilatory support and prolonged hospital stay in COVID-19 patients with DM.

Disclosure

S. Roy chaudhuri: None. A. Majumder: None. D. Sanyal: None. A. Biswas: None. K. Bhattacharjee: None.
64-OR: Metformin Improves Cardiac and Aortic Parameters in Adolescents with Type 1 Diabetes
Authors: NGUYEN ALEXANDER , TRUONG UYEN , SCHAFER MICHAL , BAUMGARTNER AMY , BARKER ALEX J. , HUNTER KENDALL S. , BURKETT DALE , REUSCH JANE E. , NADEAU KRISTEN J.
Published: June 2021

Purpose: People with type 1 diabetes (T1D) have higher rates of cardiovascular disease (CVD) despite modern advances in glucose control. While insulin resistance (IR) is known to relate to CVD in type 2 diabetes, less is understood about IR in T1D-related CVD. We previously found vascular and cardiac dysfunction, including left ventricular (LV) dyssynchrony, in adolescents with T1D. In the Effects of MEtformin on caRdiovascular function in AdoLescents with type 1 Diabetes (EMERALD) study, we also showed that metformin improves BMI, body composition, insulin sensitivity, arterial stiffness, and carotid intimal media thickness in T1D adolescents. We hypothesized that metformin, with insulin-sparing effects, would improve echocardiographically-assessed cardiac and aortic health.

Methods: 43 T1D youth ages 12-21 years (mean age 16.8 ± 2.5 years, HbA1c 8.6 ± 1.5%, BMI 25.1 ± 4.3 kg/m2, diabetes duration 7.7 ± 4.2 years) from the EMERALD study who were randomized to 3 months of either 1000 mg BID of metformin (n=23) or placebo (n=20) had echocardiograms with speckle tracking to evaluate traditional echocardiographic measures, cardiac strain and synchrony, and aortic root diameter at baseline and 3 months. One-way ANOVA and paired t-tests were utilized to assess the impacts of metformin.

Results: LV diameter (4.45 ± 0.47 vs. 4.26 ± 0.50 cm, p = 0.019) at end-diastole and at end-systole (2.89 ± 0.39 vs. 2.69 ± 0.36 cm, p = 0.022) and LV dyssynchrony (98.0 ± 36.9 vs. 81.7 ± 27.5 milliseconds, p = 0.014) showed significant improvement within the metformin group. Aortic root diameter (2.51 ± 0.39 vs. 2.73 ± 0.28 cm, p = 0.042) was also significantly lower in the metformin vs. placebo group post-treatment.

Conclusions: Metformin may be beneficial in improving or reversing early cardiovascular changes in T1D detectable by echocardiogram. A better understanding of T1D-related CVD and the benefits of improving insulin action in T1D longer-term should be investigated further as a target for new treatment modalities.

Disclosure

A. Nguyen: None. U. Truong: None. M. Schafer: None. A. Baumgartner: None. A. J. Barker: None. K. S. Hunter: None. D. Burkett: None. J. E. Reusch: Advisory Panel; Self; Medtronic. K. J. Nadeau: None.

Funding

American Diabetes Association (7-11-CD-08 to K.J.N.)
653-P: Evaluating Antidiabetic Medication Treatment Patterns in T2D Patients Initiating Once-Weekly Semaglutide (sema OW)
Authors: WILLEY VINCENT , SHIVAPPA NITIN , SWIFT CAROLINE , NOONE JOSHUA , DU SIMO , PAPROCKI YUREK M. , TAN HIANGKIAT (JASON)
Published: June 2021

Antidiabetic medication (med) treatment patterns often differ based on a variety of patient and prescriber factors. Understanding these patterns may provide insight on optimizing therapy, especially when considering initiation of a new therapy. This study presents real-world evidence on T2D treatment patterns associated with sema OW initiation within a large cohort of T2D patients.

Methods: Claims and lab result data were used to identify T2D patients from a US commercially insured/Medicare Advantage population who initiated sema OW between 12/1/17 - 6/30/20 (index as 1st claim). Selected patients had continuous health plan enrollment for ≥ 2 years pre-index and post-index through at least 90 days after the last available A1c value. Antidiabetic meds prescribed before, at the time and after initiation of sema OW were evaluated overall and for those with an A1c >9%.

Results: A total of 3,081 T2D patients were identified, of which 865 patients had A1c >9%. Sema OW was initiated down the treatment pathway, with ~60% on ≥2 and ~30% on 3+ T2D meds at sema OW initiation. Sema OW was an add-on therapy to most T2D med classes overall, although when initiated onto more complex therapy regimens it was more likely to be a therapy switch (T2D monotherapy = 24% switched to sema OW, dual therapy = 46%, triple therapy = 64%, 4+ T2D medications = 70%). Following post-index A1c measurement, 35% of patients overall and 29% with a baseline A1c >9% decreased the number of their T2D meds.

Conclusion: Sema OW appeared to be initiated as add-on therapy, except for those on more complex regimens. Approximately 1/3 of patients decreased their overall T2D med use after evaluation of A1c following sema OW initiation. Further research is warranted to assess impact of initiating sema OW earlier in the T2D treatment pathway, especially in patients with cardiovascular and chronic kidney disease.

Disclosure

V. Willey: Employee; Self; HealthCore. N. Shivappa: Other Relationship; Self; Novo Nordisk. C. Swift: Employee; Self; Novo Nordisk Inc. J. Noone: Employee; Self; Novo Nordisk Inc. S. Du: None. Y. M. Paprocki: Employee; Self; Novo Nordisk, Stock/Shareholder; Self; Novo Nordisk. H. Tan: Other Relationship; Self; HealthCore.
74-LB: Sudden Changes in Interstitial Glucose Sensing by Remote Real-Time Continuous Glucose Monitoring as a Marker of Hypoperfusion in Critically-Ill Patients with COVID-19
Authors: HESTER JOI , DAVIS GEORGIA M. , PASQUEL FRANCISCO J. , RABINOVICH MARINA , POINDEXTER NORMA , TEKWANI SEEMA
Published: June 2021

Introduction: During the COVID-19 pandemic, we implemented a protocol combining continuous glucose monitoring (CGM) with a computerized intravenous insulin infusion algorithm to care for patients with severe COVID-19.

Objective: To examine glucose trends surrounding cardiac arrest events to evaluate the performance of CGM sensors during severe clinical instability.

Methods: We reviewed eight cases of patients with type 2 diabetes diagnosed with COVID-19 requiring ICU care on IV insulin and CGM therapy experiencing severe clinical decompensation leading to cardiac arrest. Index events (cardiac arrest) were identified by staff documentation in the electronic health record. Clinical characteristics, mean arterial pressure (MAP), and point-of-care (POC) glucose values surrounding the index event were collected. CGM data was paired with MAP and POC glucose values. Rapid declines in the glucose trend [rate of change (ROC) ≥3mg/dl/min] were identified during this time of clinical instability.

Results: The mean age of patients was 61.3±13.8 years. All patients were treated with steroid therapy, vasopressors, and mechanical ventilation. 62.5% were on CRRT. Four (50%) patients had sudden cardiac arrest and drop in MAP, while the other four patients had a more prolonged decline in MAP prior to cardiac arrest. CGM values in those with sudden arrest showed an abrupt decline (≥3mg/dl/min) an average of 16.7±13.7 min following cardiac arrest. Rapid down trending of CGM values in those with prolonged hypotension occurred on average about 6 hours prior to cardiac arrest. During these episodes, the CGM values stopped correlating with POC tests.

Conclusions: Real-time CGM in critically-ill patients may provide clinical information beyond glucose control. Rapid declines in CGM values (≥3mg/dl/min) not correlating with POC glucose testing are associated with both sudden and prolonged changes in arterial pressure.

Disclosure

J. Hester: None. G. M. Davis: None. F. J. Pasquel: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Research Support; Self; Dexcom, Inc., Merck & Co., Inc. M. Rabinovich: None. N. Poindexter: None. S. Tekwani: None.
75-LB: Can Continuous Glucose Monitoring Be Utilized to Monitor Adherence to Time-Limited Eating in Adolescents with Obesity?
Authors: NAGUIB MONICA , GORAN MICHAEL I. , RAYMOND JENNIFER , HEGEDUS ELIZABETH , WEE CHOO PHEI , VIDMAR ALAINA
Published: June 2021

Background: One limitation to studying time limited eating (TLE) in adolescents is difficulty in reliably assessing adherence to fasting periods. Dietary recalls, which are currently used to monitor diet adherence, have been criticized due to potential error in reporting, omission bias and suboptimal compliance. Continuous glucose monitoring (CGM) may be a useful tool to overcome these barriers; however, it requires daily wear and understanding of expected glycemic excursions. The present study examines the feasibility of daily CGM use and its utility as a tool to monitor adherence to fasting periods in a diverse cohort of adolescents with obesity participating in a pilot study of 8-hour TLE.

Methods: Twenty adolescents (mean age 16.0+1.3 years, 70% female, 55% Latinx, 75% public insurance) with BMI ≥ 95th percentile, were enrolled in a 12-week study and randomized to: (1) Group 1 (control schedule): 12-hour eating period + blinded CGM, (2) Group 2 (TLE schedule): 8-hour eating period + blinded CGM, or (3) Group 3: 8-hour eating period + CGM with real-time feedback. CGM wear time was calculated as the actual weekly wear time divided by the prescribed wear time. At weeks 0, 4 and 12, CGM data from 7 days of self-reported fasting periods were reviewed to evaluate any glycemic excursions >50 ng/dL.

Results: Overall, the mean CGM wear time was 90% (35-100%) with no difference between intervention arms. During self-reported fasting periods, only 4 adolescents had excursions >50 ng/dL, one of whom was diagnosed with type 2 diabetes. The remaining 16 participants had no excursions >50 ng/dL during their fasting periods.

Conclusions: These data suggest that CGM may be a feasible tool to monitor adherence to TLE and provide a more accurate assessment of true fasting periods with less opportunity for error and bias when compared to self-report. Larger studies are needed to validate these findings and further explore the use of CGM as a tool in obesity research in adolescents.

Disclosure

M. Naguib: None. M. I. Goran: None. J. Raymond: None. E. Hegedus: None. C. Wee: None. A. Vidmar: None.
758-P: Treatment with Testosterone Undecanoate Injections (TU) Improves Estimated Glomerular Filtration Rate (eGFR) in Men with Hypogonadism and Type 2 Diabetes Mellitus: Update of Real-World Data
Authors: HAIDER KARIM S. , HAIDER AHMAD , SAAD FARID
Published: June 2021

Background: Reduced eGFR is associated with increased risk of cardiovascular disease and mortality.

Methods: In a registry of 865 men with hypogonadism, 361 men (41.7%) had T2DM. 183 received TU 1000 mg every 12 weeks (T-group). 178 opted against treatment (CTRL). Changes over time between groups were compared and adjusted for age, weight, waist circumference, fasting glucose, blood pressure, lipids and quality of life to account for baseline differences between the groups. eGFR was calculated using the Modification of Diet in Renal Disease (MDRD) formula.

Results: Mean follow-up 8.7±3.1, baseline age: 61.8±5.3 years. Creatinine decreased by 0.16±0.03 mg/dL (unadjusted from 0.95±0.16 to 0.83±0.09) at 12 years in the T-group and increased by 0.33±0.03 mg/dL (1.00±0.14 to 1.26±0.42) in CTRL (p<0.0001 for both). T-group: eGFR increased by 15.1±5.6 mL/min/1.73 m² (82.8±12.8 to 92.3±10.0). The peak mean value was recorded in year 9 after which a small but steady decline occurred. CTRL: eGFR decreased progressively by 22.9±5.6 mL/min/1.73 m² (77.35±13.9 to 64.4±32.5) (p<0.0001 for both). Systolic blood pressure decreased in the T-group by 33.1±1.2 mmHg (163.05±13.5 to 130.23±6.5) and increased in CTRL by 18.3±1.2 mmHg (145.6±14.6 to 158.3±15.1) (p<0.0001 for both). Diastolic blood pressure decreased in the T-group by 20.3±0.9 mmHg (97.4±10.9 to 75.4±3.3) and increased in CTRL by 12.5±0.9 mmHg (84.8±10.3 to 94.3±8.9) (p<0.0001 for both). During the entire observation period, 15 deaths (8.3%) and no cardiovascular events occurred in the T-group. In CTRL, 61 deaths (34.3%), 56 cases of myocardial infarction (31.5%) and 56 cases of stroke (31.5%) were recorded (p<0.0001 for all). Nephropathy occurred in 0.01% in the T-group and in 2.8% in CTRL (p<0.05).

Conclusions: Long-term testosterone therapy in men with hypogonadism and T2DM prevents age-related deterioration in GFR.

Disclosure

K. S. Haider: Other Relationship; Self; Bayer AG. A. Haider: Other Relationship; Self; Bayer AG. F. Saad: Consultant; Self; Bayer AG, Stock/Shareholder; Self; AbbVie Inc., Bayer AG, Novo Nordisk.

Funding

Bayer AG
761-P: Safety and Pharmacokinetic Study of GPR40 Agonist (CPL207280) after a Single Dose in Healthy Subjects
Authors: BAZYDLO-GUZENDA KATARZYNA , GIERCZAK-PACHULSKA AGNIESZKA , JARUS-DZIEDZIC KATARZYNA , RUDZKI PIOTR , WIECZOREK MACIEJ
Published: June 2021

Activation of GPR40 (G-protein coupled receptor 40) in pancreatic β-cells may improve glycaemic control in type 2 diabetes (T2D) patients through enhancement of glucose-stimulated insulin secretion (GSIS). Here we present phase I an open label, dose-escalation study with single oral administration of GPR40 agonist - CPL207280 in healthy subjects in fasting conditions. The study was performed in conventional 3+3 design, where MTD (maximum tolerated dose) is to be determined. Caucasian male and female subjects (24 volunteers) were enrolled in 8 cohorts (n=3 per). Subjects received CPL207280 in doses ranging from 5 to 480 mg. Safety assessment included adverse events (AE) reporting, clinical laboratory tests, glucose, insulin, proinsulin, c-peptide and glucagon level monitoring, vital signs, physical examination, electrocardiography (ECG). Blood samples for pharmacokinetic (PK) analysis were collected up to 48 hours after administration. CPL207280 concentrations in human plasma were evaluated by HPLC/MS/MS. Pharmacokinetic parameters were calculated using a non-compartmental modelling approach. Administration of CPL207280 was safe and well tolerated with no serious AE. All adverse events were classified as not related to the study product. Despite administration up to 480 mg of CPL207280, no dose limiting toxicity (DLT) was observed, therefore no MTD was determined. The CPL207280 exposure increased in a dose-dependent manner. The CPL207280 mean maximum plasma concentration (Cmax) values ranged from 19 to 516 ng/mL for cohort 1 and 8, respectively, and were observed at 1-3 hours after administration. The area under the curve of plasma concentration vs. time (AUC0-24h) ranged from 516 to 4603 ng/mL*h, for cohort 1 and 8, respectively. CPL207280 administration in all doses was safe and well tolerated. No adverse events were related to the study product. Pharmacokinetics of CPL207280 supports once daily dosing regimen. The results justify further clinical development.

Disclosure

K. Bazydlo-guzenda: Employee; Self; Celon Pharma SA. A. Gierczak-pachulska: Employee; Self; Celon Pharma SA. K. Jarus-dziedzic: Other Relationship; Self; Celon Pharma SA. P. Rudzki: Employee; Self; Celon Pharma SA. M. Wieczorek: Other Relationship; Self; Celon Pharma SA.

Funding

National Centre for Research and Development (POIR.01.01.01-00-0334/17)
765-P: DA-1241, a Novel GPR119 Agonist: Data on Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) from Part 2 of a Phase 1b Multiple Ascending Dose (MAD) Study in Patients with Type 2 Diabetes Mellitus (T2DM)
Authors: KIM MI-KYUNG , LEE DAE YOUNG , JEONG JIYOON , GRIMM MICHAEL , FRANEY BRIDGETTE B. , HOMPESCH MARCUS
Published: June 2021

Background and Aim: DA-1241 is a novel small molecule selective GPR119 agonist. In preclinical studies DA-1241 enhanced metabolic hormones, and improved metabolic control characteristics. The primary objective of Part 2 was to assess safety and tolerability of multiple once daily oral doses of DA-1241 versus placebo and Sitagliptin in T2DM. Secondary objectives were to establish PK and PD characteristics.

Methods: Part 2 was a double blind placebo and Sitagliptin (SG) controlled study with three sequential cohorts of T2DM (n=25/cohort) blinded and randomized (3:1:1) to receive DA-1241: 25, 50 or 100 mg (n=15/cohort), placebo (n=5/cohort) or Sitagliptin (n=5/cohort) single daily oral doses for 56 days.

Results: 84 subjects were enrolled in Part 2, 3 subjects were withdrawn due to TEAEs (1 active, 2 placebo), 72 subjects completed the study. There were no relevant demographic imbalances (Age 56.8 ± 7.3, BMI 29.4 ± 3.3). Doses tested were generally safe and well tolerated. The most frequent TEAEs were mild GI side effects (nausea, diarrhea, abdominal pain), all resolved spontaneously. Day 56 PK Cmax and AUC0-tau parameters were dose proportional. Fasting plasma glucose trended towards improvement for all DA-1241 doses, as did incremental glucose exposure after MMTTs (Change from Baseline to Day 56 iAUC 0-4h: 25mg: 18.5±89.2, 50mg: -5.1±86.8, 100mg: -38.6±58.7, Placebo: 34.4±145.9, SG: -23.9±132.8) and time spent at BG < 180 mg/dL. HbA1c trended towards improvement across dosing groups, as did body weight. GIP, GLP-1 and PYY were increased at day 56, consistent with the mechanism of action of DA-1241.

Conclusion: This phase 1b study in T2DM showed favorable safety, tolerability and PK profiles of DA-1241. Biomarkers and PD data confirmed the mechanism of action and showed favorable efficacy data trends.

Disclosure

M. Kim: Employee; Self; Dong-A ST Co. Ltd. D. Lee: Employee; Self; Dong-A ST Co. Ltd. J. Jeong: Employee; Self; Dong-A ST Co. Ltd. M. Grimm: None. B. B. Franey: None. M. Hompesch: Other Relationship; Self; Wiley, Stock/Shareholder; Self; ProSciento, Inc.
793-P: Dapagliflozin Improves Renal Function in Obese Indian Diabetics with Microalbuminuria
Authors: MAHAPATRA HARIBALLAV , MAHAPATRA LAXMINARAYAN , KHUNTIA MONALISA , SAHOO ABHAY K.
Published: June 2021

SGLT2 inhibitors have gained appreciation following their acceptance as a treatment modality for people with type 2 diabetes. These agents promote glucosuia blocking the reabsorption of glucose from the proximal convoluted tubules in the kidneys. Due to the direct role on the nephrons, initially there were some concerns over their use among the renal compromised individuals. Urinary albumin to creatinine ratio (UACR) is considered as one of the indicators to access the renal function and to classify chronic kidney disease. RAAS blockers are the standard therapeutic options for reducing urinary albumin excretion among those with or without diabetes. This study aimed to find the renoprotective effect of dapagliflozin (DAPA) among obese Indian type 2 diabetics (T2D) with microalbuminuria and compared that with RAAS blockers. We considered 182 obese adults (BMI ≥30 kg/m2) with T2D and microalbuminuria for this study. Subjects were randomized into 2 groups. Those in DAPA group (n = 86, M/F: 51/35) were administered DAPA 10 mg once daily with breakfast, whereas subjects in the comparator (RAAS) arm (n = 96, M/F 54/42) were prescribed RAAS blockers (ARBs or ACE inhibitors). From comparable UACR and HbA1c at baseline, both groups witnessed a significant decline in the UACR at 12 weeks of intervention (p<0.02). The change in the UACR from baseline was higher in the DAPA arm, though it was not statistically different from RAAS arm (145.7± 32.8 to 89.5 ± 35.8 mg/g vs. 131.5 ± 44.6 to 94.3 ± 28.2 mg/g). Additionally, DAPA arm in contrast to RAAS arm, proved their glycemic benefits by demonstrating a significant reduction in the HbA1c (1.5 ± 1.2% vs. 0.3 ± 0.6%). There was a drop in blood pressure in the study and comparator arms, but RAAS agents were found to be more effective in lowering blood pressure (P <0.03). Dapagliflozin exhibited significant and numerically better reduction in UACR compared to RAAS blocking agents among obese microalbuminuric diabetics. Use of dapagliflozin also resulted in significant Hba1c reduction.

Disclosure

H. Mahapatra: None. L. Mahapatra: None. M. Khuntia: None. A. K. Sahoo: None.