bluuebunny/crossref_metadata_2025 huggingface dataset:
518-P: User Experiences with Loop, an Open-Source Automated Insulin Delivery (AID) System
Authors: SUTTIRATANA SAKINAH , WONG JESSIE J. , LANNING MONICA S. , DUNLAP ADRIENNE , HANES SARAH , HOOD KOREY K. , LAL RAYHAN , NARANJO DIANA
Published: June 2021

Background: Loop is an open-source AID system used by more than 9,000 people with type 1 diabetes. Understanding the pros and cons of Loop use may help improve disease management and support population level innovation.

Methods: Focus groups illuminated 72 new and experienced users’ perspectives on Loop uptake, use and persistence. Participants were predominately white (95%), male (50%), privately insured (94%), reported annual household income ≥ $100K (73%) and education exceeding a bachelor’s degree (87%) with a mean HbA1c of 6.6±0.8%. Twenty discontinuers who stopped using Loop during the study (60% female, 85% white, 85% privately insured) completed interviews. Qualitative data, collected as part of the larger observational study, were analyzed and synthesized by a multidisciplinary team.

Results: High frequency thematic content described experiences with: a) technical support and troubleshooting, b) decreased mental/behavioral burden, c) technical issues with parts of the system, d) glycemic control, e) personalizing settings, and f) providers while using Loop. Users also emphatically highlighted the effects of Loop on overnight experiences and the role that “Loop communities” played during use. Decreased burden was the most endorsed benefit characterized by less worry, stress, and cognitive effort; less time spent on diabetes management tasks, and more space to think about nondiabetes aspects of life. The most discussed drawback was having technical issues with any part of the system including challenges with insulin pumps, CGMs, infusion sites, signal loss, the app, and/or the algorithm. A range of provider attitudes and knowledge about Loop complicated users’ disclosure and experiences.

Conclusions: This sample of Loop users reported benefits to quality of life and glycemic control that outweighed challenges of setting up system components and adjusting settings. Users reported being empowered by the customizability and educational effects of the open-source AID system.

Disclosure

S. Suttiratana: Employee; Spouse/Partner; CVS Health. J. J. Wong: None. M. S. Lanning: None. A. Dunlap: None. S. Hanes: None. K. K. Hood: Consultant; Self; Cecelia Health, Cercacor, LifeScan Diabetes Institute. R. Lal: Consultant; Self; Abbott Diabetes, Biolinq, Capillary Biomedical, Inc., Morgan Stanley, Tidepool. D. Naranjo: None.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust
519-P: Unmet Communication Needs and Barriers of Black and African Americans with Type 2 Diabetes
Authors: ZISMAN-ILANI YAARA , SIMINOFF LAURA A. , SAVOY MARGOT L. , PARANJAPE ANURADHA , LIU JIN , JACOB REGINA A. , GARDINER HEATHER M. , BASS SARAH B. , MONTORI VICTOR M. , RUBIN DANIEL J.
Published: June 2021

T2D is disproportionately prevalent among Black and African Americans (BAAs) and is one of the leading causes of mortality and morbidity among BAAs. T2D care is improved by patient-centered communication and Shared Decision Making (SDM). However, culturally sensitive T2D communication and SDM tools that focus on patient’s communication preferences, needs, and racial and cultural background that shape the interaction with a provider and influence treatment follow-up, are missing. The purpose of this formative study was to identify communication preferences, barriers, and needs of BAAs with T2D. Interviews were conducted with 32 BAAs with T2D served at a safety-net hospital located in a poor urban area. The sample included 17 women (53.1%), ages 31 to 81 years (58.9, SD=11.9), with a range of glycemic control (HbA1c: M=9, SD=2.7, range 6 to 14). A third (N=11) were prescribed oral medication and insulin, another third (N=11) were on oral medication only. A majority of participants (n=18, 56.3%) identified paternalistic communication, mistrust in the provider, and communication mismatch as barriers to T2D care. Receiving information about managing T2D in real-life situations (n=18, 56.3%) and patient-clinician collaboration in T2D decision-making (n=23, 72%) were the preferred communication strategies. A majority of participants stated expression of empathy, concern, and compassion by providers (n=22, 68.8%) and informal, open and direct communication (n=31, 96.9%) are needed to improve the quality of T2D care among BAAs. We identified several communication barriers and needs of BAAs with T2D with their providers, which interrupt their T2D management and treatment follow-up. There is an urgent need to improve patient-provider communication by developing culturally-sensitive communication support tools to address the communication needs and preferences of BAAs to improve SDM and the quality of diabetes care.

Disclosure

Y. Zisman-ilani: None. D. J. Rubin: Research Support; Self; AstraZeneca. L. A. Siminoff: None. M. L. Savoy: None. A. Paranjape: None. J. Liu: None. R. A. Jacob: None. H. M. Gardiner: None. S. B. Bass: None. V. M. Montori: None.
52-LB: Weight Management Practices among U.S. Safety-Net Health Center Patients with Diabetes or Other Metabolic Disorders
Authors: WANG JASON J. , SHI ZUMIN , YAN ALICE
Published: June 2021

Introduction: First-line intervention for the metabolic disorders or type 2 Diabetes is lifestyle change, including weight management, diet, and increased physical activity. This study evaluated the associations between health professional (HP) weight discussions and weight management practices among high risk safety-net patients.

Methods: Cross-sectional data on adults (aged≥18 years) with self-reported diabetes, hypertension or hyperlipidemia from the 2014 National Health Center Patient Survey (HCPS) was analyzed. The HCPS is a nationally representative survey of patients receiving care at safety-net health centers. Outcome (binary) was whether patients tried to lose weight in prior 12 months. Independent variables were HP discussing the weight problem, talking about weight loss options (i.e., exercise), suggesting a nutritionist visit, or offering weight loss medication. Logistic regression models with complex sampling design was used to test the association between HP weight discussions and the outcome, adjusted for psycho-sociodemographic covariates.

Results: Of 3671 patients, 55.5% (n=2039) tried to lose weight in prior 12 months. Women (62.4%) and Hispanic race/ethnicity (62.8%) were associated with a higher prevalence of attempting to lose weight in prior 12 months. In the fully adjusted model, having received HP’s weight discussion (AOR=5.54, 95%CI: 3.59-8.56), suggest exercise (AOR=3.61, 95% CI: 2.37-5.49), and recommend a nutritionist visit (AOR=2.59, 95% CI: 1.67-4.01) were associated for increased likelihood of attempting weight loss.

Conclusions: HP advice to lose weight may increase patients’ motivation to lose weight and weight loss behavior. Better training for HPs in delivering high-value care such as brief weight counselling could lead to improved chronic disease health outcomes for safety-net patient populations.

Disclosure

J. J. Wang: None. Z. Shi: None. A. Yan: None.
54-LB: Multidimensional Lifestyle Measures as Tools for Self-Reflection in Type 2 Diabetes
Authors: FANCHIANG SHANPIN , MORRIS KEIYANA , BOUCHONVILLE MATTHEW F.
Published: June 2021

Background: For people with diabetes, self-management is important to reduce the risks of complications. Lifestyle interventions are multidimensional because of the influence of resources, societal changes, scientific and technological advancement, and the environment. The COVID-19 pandemic has strained lifestyle on a global scale. Lifestyle surveys provide opportunities to reflect on the living experience and identify alternatives to enrich lifestyle.

Method: A qualitative approach was used to explore existing generic, none-disease specific, and multidimensional lifestyle measures to identify if these have included smartphone use for self-management to determine the potential for use as a tool for self-reflection and lifelong learning.

Results: A total of 15 multidimensional lifestyle measures were identified. All included diet/nutrition, physical activity/exercise. Stress or mental health was described in all 9 generic lifestyle measures; social support and relationship were included in 6 (67%), sleep and health responsibility were in 5 (56%), and spiritual or religious pursue was in 3 (33%). One lifestyle measure classified spirituality in the stress management dimension. None included smartphone use and technology-related chronic illness management.

Conclusion: New dimensions need to be created to use a lifestyle measure as a self-reflection learning process, including those that incorporate the use of technology. The advancement in environmental neuroscience can also shed light on a healthy lifestyle in the area of connection to nature/environment. Lifelong learning to adopt these new activities as lifestyles should also be reflected in lifestyle measures for it to be a self-administered learning tool.

Disclosure

S. Fanchiang: None. K. Morris: None. M. F. Bouchonville: None.
548-P: Understanding T2D Self-Management in Racial/Ethnic Minorities: Application of the Extended Parallel Processing Model and Sensemaking Theory
Authors: RUBIN DANIEL J. , SWAVELY DEBORAH A. , BRAJUHA JESSE , KELLY PATRICK J. , ALLEN SHANEISHA , HOADLEY ARIEL , IWAMAYE AMY , ZISMAN-ILANI YAARA , BASS SARAH B.
Published: June 2021

Behavioral health interventions are needed to address disparities among low-income racial/ethnic minorities with type 2 diabetes (T2D). We aimed to gain a better understanding of the role of disease threat perception and self-efficacy using the Extended Parallel Processing Model (EPPM) as a guide in T2D self-management among Black and Hispanic patients.

Semi-structured interviews were conducted with minority T2D patients who receive care in endocrinology, internal or family medicine practices in an urban safety-net hospital. Participants were placed in one of 4 EPPM groups based on validated questionnaires: High or low disease threat and high or low self-efficacy. The interviews were transcribed then analyzed using both inductive and deductive coding based on Sensemaking Theory.

From this ongoing study, the current analysis includes 11 interviews. The cohort had a median age of 52 years, was 55% female, 82% were black and 18% were Hispanic. Participants in the high threat groups indicated disease threat fluctuated throughout their diabetes history and that certain triggers (e.g., diabetic complications) drove changes in disease view. Participants with high threat/high efficacy (n=4) expressed acceptance of T2D and reported adequate social support, whereas those with high threat/low efficacy (n=2) expressed anger or denial about T2D. Participants with low threat/high efficacy (n=2) reported poor social support, while those with low threat/low efficacy (n=3) had heightened positive and negative emotional responses. Both low efficacy groups reported less problem-solving skills than the high efficacy groups.

Perceived health threat and low self-efficacy may impede T2D self-care, presenting barriers to achieving good diabetes control. A greater focus on the role of diabetes threat perception and self-efficacy is needed to improve T2D care among low-income minority patients.

Disclosure

D. J. Rubin: Research Support; Self; AstraZeneca. D. A. Swavely: None. J. Brajuha: None. P. J. Kelly: None. S. Allen: None. A. Hoadley: None. A. Iwamaye: None. Y. Zisman-ilani: None. S. B. Bass: None.
552-P: Impact of Stakeholder Engagement in Pediatric Type 1 Diabetes (T1D): Experience from the T1D High-Fidelity Wraparound Program (HFWP)
Authors: NEVIN AMY G. , MARCH CHRISTINE , JONES LAUREN , SCHREIBER JUSTIN , LIBMAN INGRID
Published: June 2021

Despite recent advances, management of pediatric T1D remains extremely challenging, in part due to psychological distress and poor adherence to recommendations. The HFWP aims to adapt and test an innovative strategy, used in behavioral health, to improve self-management and self-efficacy in high-risk youth with T1D. Stakeholder engagement, with the integration of patient, family and community/system partners into the research team, is increasingly recognized as a critical component of patient-centered research. We describe the process and outcomes of stakeholder engagement to inform T1D HFWP research activities and resources. A total of 21 stakeholders, representing family, youth and community/systems partners (e.g., ADA, JDRF, Health Plan), were selected through a rigorous application process and participated in monthly meetings for 13 months. Measures of satisfaction with processes and experience were obtained via an anonymous survey completed after every meeting. On average, 70% consistently answered the survey over 13 months. Stakeholders strongly agreed that the meetings met their expectations (4.75/5), objectives were identified and followed (4.5/5), their voices were heard (4.64/5) and the Advisory Board was effectively molding the T1D HFWP (4.75/5). The majority (~70%) were satisfied with meeting frequency and duration. The Advisory Board proposed important outcome measures which were adopted, including evaluation of anxiety and distress in youth and caregivers. Concrete areas of need were identified, leading to systematic development of tools, including a guide for families to vet online T1D resources and design of a practical, patient-centered form outlining a medical summary for families (e.g., insurance, type of devices used, phone numbers, etc.). This experience illustrates the willingness and importance of partnering with stakeholders to help shape resources and programs in pediatric T1D intervention research.

Disclosure

A. G. Nevin: None. C. March: None. L. Jones: None. J. Schreiber: None. I. Libman: Advisory Panel; Self; Novo Nordisk.

Funding

Children’s Hospital of Pittsburgh Foundation
554-P: Diabetes Distress in Young Adults with Youth-Onset Type 2 Diabetes: TODAY Study Results
Authors: TRIEF PAULA M. , WEINSTOCK RUTH S. , USCHNER DIANE , TUNG MELINDA , CHAO LILY , FARRELL RYAN M. , KEADY JOYCE , MACLEISH SARAH A. , MARCUS MARSHA D. , RAYAS MARIA S.
Published: June 2021

Aims: Diabetes distress (DD) is associated with poor health outcomes. Little is known about level of DD in young adults (YAs) with youth-onset type 2 diabetes (T2D) or individual factors associated with DD. Aims were to assess level of DD, and factors associated with high DD, in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY2) cohort.

Methods: YAs completed the Diabetes Distress Scale (DDS), PHQ-9 (depressive symptoms) and GAD7 (anxiety), at the end-of-study visit. Factors that may relate to DD were demographics (sex, race/ethnicity, age, education, income), medical history (HbA1c, BMI, complications), and social/economic factors (# persons in household, parent status, healthcare coverage, access to diabetes care provider). Univariate logistic regressions found factors associated with high DD. Multivariate regression controlled for sex, HbA1c, healthcare coverage, anxiety, depressive symptoms and retinopathy.

Results: Of 457 YAs, mean age=26.7 yrs, 65% were female, 20% non-Hispanic white, 38% non-Hispanic Black, 20% Hispanic, 62% <$25K income. High DD (DDS ≥2) was reported by 108 (23.6%). Subscales found 39.8% with high “regimen distress,” 29.8% with high “emotional burden” (29.8%). Unadjusted results: Sex (p=0.001), HbA1c (p<0.0001), no healthcare coverage (p=0.043), hypertension (p=0.036) and retinopathy (p=0.005) were associated with DD. Moderate-severe depressive symptoms (PHQ-9 ≥10) and anxiety (GAD≥5) were also associated with DD (p<0.0001). In multivariate analyses, female sex, anxiety, HbA1c (p<0.0001 for all), and no healthcare coverage (p=0.022) remained associated with DD. Individual microvascular complications, BMI, depressive symptoms, race/ethnicity, age, education, income, # persons in household, or having a diabetes care provider did not relate to adjusted DD.

Conclusion: In young adults with youth-onset T2D, high DD was significantly more likely in females, and those with anxiety, high HbA1c, and without healthcare coverage.

Disclosure

P. M. Trief: None. M. S. Rayas: Research Support; Self; National Center for Advancing Translational Sciences. R. S. Weinstock: Research Support; Self; Boehringer Ingelheim International GmbH, Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Kowa Research Institute, Inc., Medtronic, Tolerion, Inc. D. Uschner: None. M. Tung: None. L. Chao: None. R. M. Farrell: Stock/Shareholder; Self; Tandem Diabetes Care. J. Keady: None. S. A. Macleish: Advisory Panel; Self; Insulet Corporation. M. D. Marcus: Advisory Panel; Self; Weight Watchers International, Inc.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (U01DK61212, U01DK61230, U01DK61239, U01DK61242, U01DK61254)
591-P: Glucose Dynamics during OGTT Identify Metabolic Subphenotypes in Individuals with Glucose Dysregulation
Authors: METWALLY AHMED A. , PERELMAN DALIA , PARK HEYJUN , CELLI ALESSANDRA , MCLAUGHLIN TRACEY , SNYDER MICHAEL
Published: June 2021

Type 2 diabetes (T2D) is a heterogeneous disorder, with a complex physiologic basis. Muscle insulin resistance, beta-cell dysfunction, and impaired incretin effect may be present to differing degrees. Identifying the underlying physiology of glucose dysregulation in a given individual would allow for tailored treatment. We hypothesized that glucose dynamics (i.e., glucotypes) during a frequently-sampled 3-hour OGTT could identify the underlying pathophysiology of glucose dysregulation. If true, glucotypes from OGTT and/or continuous glucose monitoring devices may extend current diagnostic approaches for T2D by defining the dominant metabolic subphenotype.

A total of 33 participants underwent gold-standard metabolic tests including: OGTT with blood sampled every 5-10 min for 180 min with c-peptide deconvolution, isoglycemic intravenous glucose infusion (IIGI), and modified insulin suppression test (IST), to quantify beta-cell function, incretin effect, and insulin resistance. Glucotypes were constructed from a time series with glucose values from the OGTT. Missing timepoints were imputed using cubic smoothing splines. Each series was Z-normalized to focus on the shape of the curve rather than the amplitude. Singular value decomposition was performed and the first two principal components were used in cluster analysis, and related to gold-standard metabolic tests.

Cluster analysis of glucose dynamics variables revealed 2 separable clusters identifying individuals classified as insulin resistant or sensitive based on IST. Beta-cell dysfunction was also distinguishable by cluster analysis. Although impaired incretin effect status was identified using the deconvolution of the c-peptide from the OGTT and IISI, it was not clearly separable through glucotypes.

Glucotypes may be used to identify metabolic subphenotypes in glucose-dysregulated states, with the potential to personalize treatment approaches that address the dominant physiologic defect.

Disclosure

A. A. Metwally: None. D. Perelman: None. H. Park: None. A. Celli: None. T. Mclaughlin: Board Member; Self; January, Inc. M. Snyder: Research Support; Self; Fitbit, Inc., Stock/Shareholder; Self; January, Inc., Qbio.

Funding

National Institutes of Health (5R01DK110186-02); Precision Health and Integrated Diagnostics Center at Stanford
626-P: Intermittently Scanned Continuous Glucose Monitoring Data of Polish Patients from Real-Life Conditions: More Scanning and Better Glycemic Control than Worldwide
Authors: HOHENDORFF JERZY , GUMPRECHT JANUSZ , MYSLIWIEC MALGORZATA , ZOZULINSKA-ZIOLKIEWICZ DOROTA , MALECKI MACIEJ
Published: June 2021

Randomized trials and observational studies have shown that the use of FreeStyle Libre® intermittently-scanned CGMS was associated with improved glycemic indices such as HbA1c, TIR (70-180 mg/dl), TBR (<70 mg/dl) or TAR (>180 mg/dl), and improved quality of life. In this RWD analysis, we aimed to describe glucometrics among FreeStyle Libre users from Poland and compare them with international data. The analyzed time period for the Polish and worldwide users ranged from August 2016, September 2014, respectively, to August 2020. Data from the Polish population was collected from 10,679 readers and 92,627 sensors with 22.3 million glucose scans and 113 million automatically-recorded glucose readings, while the worldwide database included information from 981,876 readers and 11,179,229 sensors with 13.1 billion glucose readings. On average, the Polish users of isCGM performed substantially more scans/day (21.2±14.2 vs. 13.2±10.7), were characterized by considerably lower eHbA1c (7.0±1.2% vs. 7.5±1.5%), spent more TIR (64.2±17.3% vs. 58.1±20.3%) and less TAR (29.7±18.0% vs. 36.6±21.3%) (p<0.0001 for all comparisons). Moreover, Polish users were more likely to achieve TIR>70% (36.3% vs. 28.8%). Our results confirmed earlier findings that analyzed glucometrics improve as scan rate frequency increases; however, additional analyses showed that at the same scanning frequency, Polish users achieved lower eHbA1c, higher TIR, lower TAR, but higher TBR than the comparative group.

In summary, we report more scanning and better glycemic control in Polish isCGM users than worldwide. Due to the nature of this study, we are not able to explain the cause of this observation. It could be associated with demographic characteristics, such as a higher proportion of adult users, or more efficient diabetes education. Our data seems to suggest more frequent scanning than currently recommended.

Disclosure

J. Hohendorff: Advisory Panel; Self; Abbott, Roche Diabetes Care, Other Relationship; Self; Merck & Co., Inc., Polfa Tarchomin S. A. J. Gumprecht: Advisory Panel; Self; Abbott, Research Support; Self; Bayer AG, Merck & Co., Inc., Speaker’s Bureau; Self; AstraZeneca, Bioton S. A., Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MSD Corporation, Novo Nordisk A/S, Sanofi. M. Mysliwiec: None. D. Zozulinska-ziolkiewicz: None. M. Malecki: Advisory Panel; Self; Abbott Diabetes, Medtronic, Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck & Co., Inc., Mundipharma International, Novo Nordisk, Sanofi-Aventis, Servier Laboratories.
657-P: Potential Effect of a Novel Combination of GLP-1RA (efpeglenatide) and Long-Acting Glucagon Analog (HM15136) in Animal Models of Metabolic Disorders
Authors: LEE JONG SUK , KIM JUNG KUK , LEE SEON MYEONG , CHOI JAEHYUK , PARK EUNJIN , KIM DAEJIN , BAE SUNGMIN , LEE SANG HYUN , CHOI IN YOUNG
Published: June 2021

In addition to glycemic control, GLP-1RA efficacy is established in obesity. However, more efforts are still required to close efficacy gap with bariatric surgery. Recent studies demonstrate the favorable effect of glucagon (GCG) receptor activation on energy expenditure and hepatic lipid metabolism. So, combination of GCG with GLP-1RA not only enhances body weight loss (BWL) barely achieved by current therapy, but also expands its therapeutic utility to various metabolic disorders. Previously, we confirmed the long-acting GCG properties of HM15136 from animal to human. In addition, GLP-1 class effect of efpeglenatide (Efpe), once-weekly GLP-1RA, was confirmed in clinical studies. Thus, to develop a novel combination therapy, we investigated potential effects of Efpe and HM15136 combination in animal models of metabolic disorders. In DIO mice, 4 weeks treatment of Efpe and HM15136 combination (COMBO) showed more BWL than Efpe mono treatment. Of note, greater BWL was also confirmed for COMBO treatment compared to acylated GLP-1/GIP co-agonist (-18.5, -55.9, -44.9% vs. vehicle for Efpe, COMBO, GLP-1/GIP). Similar results were observed when measuring fat mass (-19.5%, -83.8%, -77.2% vs. vehicle for Efpe, COMBO, GLP-1/GIP) and blood lipid profiles (total cholesterol: -41.8%, -82.0%, -63.2% vs. vehicle for Efpe, COMBO, GLP-1/GIP) in DIO mice. To further demonstrate benefits of this novel COMBO, additional study was performed in DIO/STZ rats, and COMBO treatment consistently showed more BWL than Efpe (-5.1, -12.1% vs. vehicle for Efpe, COMBO) along with numerically more HbA1c reduction (-1.0, -1.5% vs. vehicle for Efpe, COMBO). Therefore, HM15136 might be a novel COMBO partner for Efpe, providing enhanced BWL and favorable metabolic profiles. These results warrants further evaluation for therapeutic potential of this novel COMBO in various metabolic disorders including dyslipidemia and NASH.

Disclosure

J. Lee: Employee; Self; Hanmi Pharmaceutical. J. Kim: Employee; Self; Hanmi Pharmaceutical. S. Lee: Employee; Self; Hanmi Pharmaceutical. J. Choi: Employee; Self; Hanmi Pharmaceutical. E. Park: Employee; Self; Hanmi Pharmaceutical. D. Kim: Employee; Self; Hanmi Pharmaceutical. S. Bae: Employee; Self; Hanmi Pharmaceutical. S. Lee: Employee; Self; Hanmi Pharmaceutical. I. Choi: Employee; Self; Hanmi Pharmaceutical.
742-P: Phase 1 Study of Safety, Tolerability, PK, and PD of Once-Weekly Basal Insulin Fc (BIF) in Japanese Patients with T2DM
Authors: OHWAKI KENJI , FURIHATA KENICHI , NASU RISA , OURA TOMONORI , IMORI MAKOTO
Published: June 2021

BIF (LY3209590) is a novel, once weekly, long-acting IgG Fc-fusion protein that is being assessed for the treatment of diabetes mellitus. This phase 1, multiple-site, randomized, single-dose, dose-escalation study of BIF included 3 cohorts. Cohorts 1 and 2 each included 12 Japanese insulin-naïve patients with T2DM who were randomized double-blind to receive a single SC dose (dose 1 in cohort 1; dose 2 in cohort 2) of BIF (N=8) or placebo (N=4). Cohort 3 included 7 Japanese patients with T2DM previously treated with basal insulin, with or without a stable dose of up to 2 prespecified types of oral anti-hyperglycemic medications, who received a single SC dose of open-label BIF at dose 3. The primary objective was to investigate safety and tolerability. Secondary objectives included characterization of the PK and PD. ClinicalTrials.gov identifier: NCT03603704. Four patients (12.9%; 1 patient in each treatment group) reported a treatment-emergent adverse event; all were mild and none were related to study drug. Six patients (19.4%) reported hypoglycemic events (most events were with dose 3 and none were severe); each event was self-treatable and resulted in a prompt recovery. PK analyses showed BIF exposure after administration of each dose increased with dose, and tmax was observed by approximately day 4 at all 3 doses. The geometric mean t1/2 estimates ranged from 11 to 16 days across doses. All 3 doses decreased fasting glucose from baseline to day 15. Fasting glucose decreased from day 2 until approximately day 7 or 8 at all doses followed by a trend of fasting glucose returning to baseline. Compared with placebo, BIF at doses 1 and 2 significantly decreased (p<0.1) fasting glucose levels from baseline at most time points between days 3 and 15. In Japanese patients with T2DM, single SC doses of BIF were well tolerated, and the PK and PD of BIF allows weekly dosing.

Disclosure

K. Ohwaki: Employee; Self; Eli Lilly Japan K. K., Stock/Shareholder; Self; Eli Lilly and Company. K. Furihata: None. R. Nasu: Employee; Self; Eli Lilly Japan K. K. T. Oura: Employee; Self; Eli Lilly Japan K. K., Stock/Shareholder; Self; Eli Lilly and Company. M. Imori: Employee; Self; Eli Lilly Japan K. K.

Funding

Eli Lilly and Company
762-P: Use of Oral Hypoglycemic Agents in Type 1 DM
Authors: ROMO KARINA G. , WEST WILLIAM A. , UWAIFO GABRIEL I.
Published: June 2021

Obesity prevalence in T1DM is increasing. While T1DM is typically treated exclusively with insulin, the changing obesity trends and T1DM heterogeneity has raised interest in use of various oral hypoglycemic agents (OHA) as adjunctive therapy. The extent and impact of OHA “off label” use in “real world” settings is not well studied. We report on the extent, distribution, glycemic and cardiometabolic impact of OHA use in a T1DM cohort. Retrospective chart review of 300 patients with health record coded T1DM seen between January 2015 and January 2018 was done. OHA use, comorbidities, demographics, vital signs, and cardiometabolic risk surrogates were extracted for analyses.. The chart review showed actual DM subtypes were :163 (54%) T1DM, 43 (14.3%) Latent Autoimmune Diabetes of Aging (LADA), 1 (0.3%) maturity-onset diabetes of the young, 2 (0.7%) type 1.5 (essentially LADA), 8 (2.7%) type 1+2 (T1DM with obesity and insulin resistance), 11 (3.7%) deceased, and 71 (23.7%) T2DM that had been miscoded as T1DM. All subsequent analyses included T1DM, LADA, type 1.5, and type 1+2 in the verified T1DM cohort. 16% of the T1DM cohort were on at least one OHA and most common were sulphonylureas (16%), DPP-4 blockers (15.3%), SGLT-2 blockers (11%) and metformin (9.2%). OHA use in T1DM was not associated with any significant change in weight, BMI nor blood pressure. There was however a statistically significant decline in total cholesterol, LDL and HBA1c but not fasting triglycerides. No significant differences were found in hypoglycemia related admissions or DKA admissions with OHA use including among SGLT-2 users. Off label use of OHAs is quite prevalent in the studied population of patients with T1DM (16%) and their use was associated with improvements in HBA1c and aspects of lipid metabolism despite no significant changes in weight, BMI or blood pressure. OHAs may have utility as adjunctive therapy and require more structured study to enable development of therapeutic algorithms for their use in T1DM therapeutics.

Disclosure

K. G. Romo: None. W. A. West: None. G. I. Uwaifo: None.
802-P: Dapagliflozin Improves Glycolytic Reserve in Peripheral Blood Mononuclear Cells in Patients with Type 1 Diabetes
Authors: MELO JOANA , LAURSEN JENS CHRISTIAN , HEINRICH NIELS S. , RASMUSSEN IDA B. , HANSEN CHRISTIAN S. , FRIMODT-MOELLER MARIE , ROSSING PETER , STØRLING JOACHIM
Published: June 2021

Sodium-glucose cotransporter-2 (SGLT2) inhibition is emerging as a beneficial adjunctive therapy in type 1 diabetes (T1D). It is hypothesized that SGLT2 inhibition relieves hypoxia in the kidneys. As mitochondrial dysfunction might contribute to kidney hypoxia, SGLT2 inhibition could ameliorate hypoxia via restored mitochondrial respiration. Changes in metabolic processes in peripheral blood mononuclear cells (PBMCs) are associated with various diseases including diabetes. PBMCs are an easily accessible reporter cell population to test changes in cellular metabolism caused by changes in blood glucose. The aim of this study was to investigate the effects of a single dose of 50 mg dapagliflozin compared to placebo on PBMCs’ bioenergetics in individuals with T1D in a double blinded randomized crossover study with a two-week washout period. With Seahorse extracellular flux technology, we analysed the efficiency of mitochondrial oxidative phosphorylation and glycolysis in PBMCs obtained from a fresh blood sample of each study participant before and after intervention. Fifteen individuals (33% females) with mean (±SD) age 58 (±14) years and Hba1c 8.0 (±0.6) % were included. Dapagliflozin did not influence PBMC mitochondrial oxidative phosphorylation. However, dapagliflozin significantly improved PBMC glycolytic reserve by 35% (mean ±SE, 3.5 ±0.3 e-6 ECAR/cell number) compared to baseline (2.6 ±0.5 e-6 ECAR/cell number). Our results suggest that dapagliflozin enhances PBMCs’ flexibility to use glycolysis as an energy supply pathway in individuals with T1D. This study advances our mechanistic understanding of the subtle changes in systemic metabolism and the beneficial effects at the cellular level of SGLT2 inhibition in patients with T1D.

Disclosure

J. Melo: None. J. Laursen: None. N. S. Heinrich: Stock/Shareholder; Self; Akebia Therapeutics, Inc., Novo Nordisk A/S. I. B. Rasmussen: None. C. S. Hansen: None. M. Frimodt-moeller: None. P. Rossing: Advisory Panel; Self; Astellas Pharma Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Gilead Sciences, Inc., Merck KGaA, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Vifor Pharma Management Ltd. J. Størling: None.
808-P: Economic Benefits of Initiating Empagliflozin vs. GLP-1 Receptor Agonists among Patients with Type 2 Diabetes
Authors: PIMPLE PRATIK , RAJU ADITYA , FARRELLY EILEEN , SHETTY SHARASH
Published: June 2021

Background: SGLT-2 inhibitors and GLP-1 receptor agonists (GLP-1RAs) have proven clinical benefit profiles, and the ADA recommends both as treatment options for T2D patients uncontrolled on metformin. There is limited research on whether these clinical benefits translate into differential cost savings. This study sought to assess the all-cause (AC) healthcare costs associated with initiating empagliflozin (EMPA) vs. GLP-1RAs among patients with T2D.

Methods: A commercial US claims database was used to identify patients with T2D who newly initiated EMPA or GLP-1 RA from 08/2014-09/2018. Study cohorts (EMPA users and GLP-1RA users) were matched using propensity scores (PSs) (1:1 ratio, caliper: ± 0.05) based on baseline demographic and clinical variables. AC costs were computed on a per patient per month (PPPM) basis during a variable follow-up period of up to 12 months and compared across study cohorts using generalized linear models. A subanalysis comparing AC costs among patients who initiated second-line treatment with EMPA or GLP-1RA after metformin monotherapy was also conducted.

Results: PS matching resulted in a sample of 43,588 patients (21,794 patients in each group) whose mean age was 54 years and 63% were male. The total AC PPPM costs were significantly lower for EMPA vs. GLP-1RA users ($1,450 vs. $1,723; Δ = $273; P<0.001), with both pharmacy (Δ = $195; P<0.001) and medical (Δ = $78; P=0.006) costs being significantly lower. Similar results were observed in the subanalysis where initiating EMPA after metformin monotherapy was associated with lower AC PPPM costs compared to GLP-1RA users (Δ = $271; P<0.001).

Conclusion: Among patients with T2D, initiating EMPA vs. GLP-1RA was associated with lower AC healthcare costs, where the drivers were both lower medical and pharmacy costs. These findings can inform treatment selection processes that are aimed to optimize T2D management, especially from an economic perspective.

Disclosure

P. Pimple: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc. A. Raju: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Takeda Pharmaceutical Company Limited, Employee; Self; Xcenda LLC, Stock/Shareholder; Self; Teva Pharmaceutical Industries Ltd. E. Farrelly: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Takeda Pharmaceutical Company Limited, Employee; Self; Xcenda LLC. S. Shetty: Employee; Self; Boehringer Ingelheim Pharmaceuticals, Inc.

Funding

Boehringer Ingelheim
810-P: The Diminishing Cost-Effectiveness of the Newer Glucose-Lowering Drugs in the United States, 2010-2018
Authors: LI PIAOPIAO , PATEL RAHUL S. , VOURI SCOTT M. , SHI LIZHENG , FONSECA VIVIAN , SHAO HUI
Published: June 2021

Background: The difference between the costs of the newer and older glucose-lowering drugs has been steadily increasing since 2010. In 2018, newer drugs cost 8-12 times more than older drugs (except for insulin). This study aimed to understand how this change in drug cost influenced the cost-effectiveness (CE) of newer drugs compared with older drugs.

Methods: We conducted a systematic literature review to identify US-based CE studies comparing newer (i.e., dipeptidyl peptidase-4 inhibitors (DPP4), glucagon-like peptide 1 receptor agonists (GLP1-RA), and sodium-glucose transport protein 2 inhibitors) with older glucose-lowering drugs. The identified 12 studies all reported the CE of newer drugs based on drug costs estimated before 2010. We have updated the corresponding CE of each study by replacing the old cost estimates with 2018 estimates from the 2018 IBM® MarketScan® Commercial Claims Databases. The time window and willingness to pay threshold were consistent with each original study.

Results: Only 8% of the original studies suggested that the older drugs were cost-effective. However, 58% of studies were in favor of the older drugs after the cost update. Among the 4 studies comparing newer drugs with thiazolidinediones, all studies suggested thiazolidinedione to be cost-effective in the updated analysis, while the original results all favored newer drugs. For the 4 studies comparing newer drugs with sulfonylureas, 2 studies suggested the sulfonylureas to be cost-effective after the cost update. All 4 studies suggested newer drugs to be cost-effective when compared with insulin in the original study. Only 1 flipped its conclusion when 2018 costs were used. Our sensitivity analysis shows that our results are robust up to a 30% rebate.

Conclusion: Significant changes in the cost of glucose-lowering drugs have impacted the economic value of different glucose-lowering agents substantially. More CE analyses are warranted to support the drug choice in T2DM management.

Disclosure

P. Li: None. R. S. Patel: None. S. M. Vouri: None. L. Shi: Research Support; Self; AstraZeneca, Sanofi. V. Fonseca: Consultant; Self; Abbott Diabetes, Asahi Kasei Corporation, Bayer Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Intarcia Therapeutics, Inc., Novo Nordisk, Pfizer Inc., Sanofi-Aventis, Stock/Shareholder; Self; Amgen Inc., Bravo4health, Mellitus Health. H. Shao: Research Support; Self; Sanofi.
830-P: The Development of a New Computer Adaptive Test of Illness Burden for Use in People with Type 2 Diabetes Mellitus (T2DM)
Authors: MITCHELL SUZANNE , KALLEN MICHAEL A. , BRAGG ALEXA , MOLDOVAN IOANA , HOWARD JESSICA M. , JACK BRIAN W. , MINER JENNIFER A. , GRAVES CHRISTOPHER M. , CARLOZZI NOELLE
Published: June 2021

In recent years, a growing body of research has established that social determinants of health influence the health outcomes of patients, especially those with T2DM. We developed a new patient-reported outcome (PRO) measure of an important social determinant of behavior that is specific to persons with T2DM: illness burden. Qualitative and quantitative methods informed the development of this new PRO. A literature review and semi-structured key informant interviews guided the establishment of an initial item pool. Expert and patient review, reading level assessment (to ensure no item had >5th grade reading-level language), and a translatability review were all used to refine the original item pool to 47 items. The refined item pool was then tested in 225 patients with T2DM. No items had sparse response option cells or problems with monotonicity; two items were deleted due to low item-rest correlations. Factor analyses (exploratory and confirmatory) supported the retention of 29 items. With those 29 remaining items, a constrained (common slope) graded response model (GRM) fit assessment indicated that two items had misfit and were excluded. No items displayed differential item functioning by age, sex, education, or socio-economic status. Thus, the final item bank is comprised of 27 items. Psychometric considerations (based on item information values) were used, in conjunction with expert content review, to select a 6-item static short form. IRT-based item parameters were employed to make this new measure available as a computer adaptive test. Internal consistency of the new PRO was excellent (α ≥ .90 for all administration formats). The new Illness Burden item bank captures patients’ perceptions of the impact that having T2DM has on their daily lives. It can be used in conjunction with the broader measurement system, the Re-Engineered Discharge for Diabetes Computer Adaptive Test, to evaluate important social determinants of behavior in persons with T2DM.

Disclosure

S. Mitchell: Other Relationship; Self; See Yourself Health LLC, Speaker’s Bureau; Self; Merck Sharp & Dohme Corp. M. A. Kallen: None. A. Bragg: None. I. Moldovan: None. J. M. Howard: None. B. W. Jack: None. J. A. Miner: None. C. M. Graves: None. N. Carlozzi: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (1R21DK121092)
855-P: Health Care Delivery for Young Adults (YAs) with Type 1 Diabetes (T1D) during the Pandemic
Authors: SHAPIRA AMIT , TINSLEY LIANE J. , FREINER EMILY , LAFFEL LORI M. , TOSCHI ELENA
Published: June 2021

Background: YAs, aged 18-30 years, with T1D have high risk of worsening glycemic control and loss to follow-up. In March 2020, the COVID-19 pandemic required a sudden change in healthcare delivery from in-person to telehealth visits. We aimed to evaluate use of telehealth by YAs with T1D during this time and assess characteristics associated with telehealth usage.

Method: Frequency of telehealth visits from 3/16/2020 to 9/30/2020 was compared with in-person visits during the same calendar period before COVID-19 (3/16/2019 to 9/30/2020) in a sample of YAs with T1D seen by pediatric and adult diabetes clinicians. The Electronic Health Record provided demographic and clinical data for YAs aged 18-30 with a pre-pandemic A1c. Descriptive statistics and t-tests compared data before and during COVID-19.

Results: Pre-COVID-19, there were 1177 YAs (50% male) with mean±SD age 24.4±3.4 years, T1D duration 12.8±5.9 years, and A1c 8.1±1.6%; 46% were pump-treated, 55% used CGM, and 91% had private insurance. In 2019, there were 2961 visits; in 2020, there were 2701 visits. For the two 6-month periods, the mean number of visits per YA declined significantly, from 2.5±2.5 in 2019 to 2.3±3.1 in 2020 (p=.02). Further, 20% (n=240) of YAs had no visits during the pandemic period. YAs with an A1c <7% pre-pandemic (21%, n=247) had fewer visits during the pandemic than before the pandemic (1.6±2.7 vs. 2.2±2.7, p=.001). YA males (p=.01), those using CGM (p=.02), and those on injection based therapy (p=.0002) had fewer visits during COVID-19.

Conclusions: The majority of YAs (80%) maintained follow-up T1D care during the initial six months of telehealth implementation due to COVID-19, especially those with less favorable characteristics (e.g., A1c ≥7%, no CGM use). Maintaining telehealth options can become an effective means to improve future health outcomes for at-risk groups, such as YAs with T1D.

Disclosure

A. Shapira: None. L. J. Tinsley: None. E. Freiner: None. L. M. Laffel: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Dompe, Insulogic LLC, Janssen Pharmaceuticals, Inc., Laxmi Therapeutic Devices, LifeScan, Lilly Diabetes, Medtronic, Provention Bio, Inc. E. Toschi: Consultant; Self; Medtronic.

Funding

Thomas J. Beatson, Jr. Foundation; National Institutes of Health (T32DK007260, P30DK036836)
862-P: Impact of COVID-19 on Pediatric Endocrinology Practice and Diabetes Care in Children: A Survey
Authors: CHAMBERS MELISSA , SINHA MADHUMITA
Published: June 2021

Objective: As the global pandemic caused by the SARS-CoV-2 virus continues unabated, healthcare delivery has been altered significantly impacting patients and providers. We examined the impact of COVID-19 on pediatric endocrinology practice and the challenges faced in pediatric diabetes care.

Methods: A 27-item electronic survey was designed, pilot-tested, and deployed to pediatric endocrinology providers using the e-mail discussion lists of the American Academy of Pediatrics, Section on Endocrinology, and the Pediatric Endocrinology Clinical Case Mailing List (May and June 2020). The survey had questions regarding changes in practice, telemedicine use, and observed changes in diabetes disease manifestation.

Results: 114 unique responses were analyzed, 79.3% were female respondents. Most (95.6%) providers surveyed were practicing in the United States, and 87.7% reported a decline in their patient volume. Telemedicine use was common [97% (95% CI: 92.4% - 99.4%)] and recent [83.3% (95% CI: 75.2% - 89.7%)] with 98% utilizing remote glycemia monitoring tools. Children with diabetes in underserved and remote locations faced significant barriers to telemedicine use such as lack of connectivity (61%), and devices (59%). Negative consequences on health due to the pandemic included, delay in diabetes diagnosis (33.3%), lack of follow-up (22.0%) and higher diabetic ketoacidosis cases (22.0%). Increased anxiety was commonly reported (66%).

Conclusion: The COVID-19 pandemic has led to decline in patient volumes, with rapid adaptation to telemedicine use. Providers noted negative effects due to the pandemic on diabetes care including mental health. Benefits from telemedicine use were observed with a digital divide in underserved populations.

Disclosure

M. Chambers: None. M. Sinha: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases
875-P: Breathe Diabetes Management Program: A Personalized App to Assist Type 2 Diabetics in India to Achieve Healthy Outcomes
Authors: GOYAL PAWAN K. , VERMA ROHAN , KAICKER ADITYA , DEKA SAURAV , PALUKURI SRIVANI , CHANDOLIA BETINA
Published: June 2021

Introduction: Use of Digital therapeutics can act as a valuable tool enabling more personalized care among diabetics. The Breathe Diabetes Management Program (BDMP) delivers personalized interventions encouraging them to track their blood glucose level, weight, and physical activity.

Objective: To assess BDMP app in type 2 diabetics in achieving healthy outcomes in Indian population.

Methodology: The group of participants (N=181, A1C >6.5%) was divided into 3 groups - (1) patients treated with the BDMP plus Doctor-prescribed medication (n=60), (2) patients treated with the BDMP plus Doctor-prescribed medication plus Stress Reduction module (n=61) and (3) patients only taking the Doctor-prescribed medication (control group with n=60).

Results: At the end of the 16 weeks, patients from Group 1 showed 81.6% program completion rate, 46.01% program adherence, an average of 5.64% of baseline body weight loss, an average of 0.68% reduction in A1C and Penn State Worry Questionnaire (PSWQ) score average change from 56.3 to 44.5 (score ranges 16-80, higher score indicates higher worry). Patients from Group 2 showed 88.5% program completion rate, 51.95% program adherence, an average of 6.02% of baseline body weight loss, average of 0.74% reduction in A1C and a PSWQ score average change from 58.6 to 40.8. Patients from Group 3 showed an average of 0.38% of baseline body weight loss, average of 0.28% reduction in A1C and a PSWQ score average change from 56.2 to 55.5. The difference between all the groups was found to be statistically significant (p<0.05).

Conclusion: The BDMP helped the patients of Group 1 in significant weight loss, reduction in A1C, and improved stress levels. BDMP along with the Stress Reduction module in Group 2 produced even better outcomes. The results suggest that Digital Therapeutics is a scalable and sustainable solution to the growing problem of type 2 diabetes, and that mental well-being should be considered a part of the solution.

Disclosure

P. K. Goyal: None. R. Verma: None. A. Kaicker: None. S. Deka: None. S. Palukuri: None. B. Chandolia: None.