bluuebunny/crossref_metadata_2025 huggingface dataset:
770-P: The Glucose-Lowering Effect of the Bile Acid Sequestrant Sevelamer Is Not Mediated by Glucagon-Like Peptide-1
Authors: NERILD HENRIETTE H. , BRØNDEN ANDREAS , SONNE DAVID P. , HOLST JENS J. , VILSBØLL TINA , KNOP FILIP K.
Published: June 2021

Bile acid sequestrants are cholesterol-lowering drugs, which also improve glycemic control in patients with type 2 diabetes (T2D). The mechanism behind the glucose-lowering effect of bile acid sequestrants is unknown but has been proposed to involve glucagon-like peptide 1 (GLP-1) secretion. Using the GLP-1 receptor antagonist exendin(9-39), we investigated the GLP-1-mediated contribution to the glucose-lowering effect of the bile acid sequestrant sevelamer in patients with T2D.

In a randomized, double-blind, placebo-controlled, crossover study, patients (9 men/6 women) with T2D (median [interquartile range] age 68 [63-71] years, BMI 30.1 [26.6-33.0] kg/m2, HbA1c 48 [45-61] mmol/mol (6.5 [6.3-7.7]%), on metformin mono-therapy) underwent two 14-day treatment periods with either sevelamer or placebo in a randomized order. After each treatment period, patients participated in two experimental days, each involving a four-hour liquid meal test with concomitant infusion of exendin(9-39) or saline.

Compared to placebo, sevelamer lowered both fasting plasma glucose concentrations ((mean ± SEM) 8.7 ± 0.3 vs. 10.2 ± 0.5 mmol/L, P <0.001) and postprandial plasma glucose excursions (baseline-subtracted area under the curve (bsAUC): 456.5 ± 40.3 vs. 620 ± 63.6 mmol/L × min, P <0.001). In both treatment periods, exendin(9-39) increased the glucose bsAUC compared to saline (P <0.001) with no absolute or relative difference between the two treatment periods (∆bsAUC: 365 ± 34.4 mmol/L × min [170 ± 27.6%] (sevelamer) vs. 428 ± 58.2 mmol/L × min [165 ± 40.2%] (placebo treatment), P = 0.17).

In conclusion, using the GLP-1 receptor antagonist exendin(9-39), we were not able to detect a GLP-1-mediated glucose-lowering effect of sevelamer; leaving the mechanism behind the glucose-lowering effect of sevelamer unresolved.

Disclosure

H. H. Nerild: Employee; Spouse/Partner; Novo Nordisk. A. Brønden: None. D. P. Sonne: None. J. J. Holst: Consultant; Self; Novo Nordisk, Other Relationship; Self; Antag Therapeutics, Bainan Biotech, MSD Corporation, Novo Nordisk, Other Relationship; Spouse/Partner; Antag Therapeutics, Bainan Biotech, Synklino ApS. T. Vilsbøll: Consultant; Self; Amgen Inc., AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Gilead Sciences, Inc., Lilly Diabetes, Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk, Sanofi, Sun Pharmaceutical Industries Ltd. F. K. Knop: Advisory Panel; Self; MSD Corporation, Novo Nordisk A/S, Sanofi, Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk A/S, Pharmacosmos, Zealand Pharma A/S, Research Support; Self; Novo Nordisk A/S, Zealand Pharma A/S, Speaker’s Bureau; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MSD Corporation, Novo Nordisk A/S.
779-P: Prescribing of SGLT2 Inhibitors in Primary Care: A Qualitative Study of Primary Care Physicians and Endocrinologists
Authors: MILDER TAMARA , STOCKER SOPHIE , BAYSARI MELISSA , DAY RICHARD O. , GREENFIELD JERRY
Published: June 2021

Aims: To explore: 1) Primary Care Physicians’ (PCPs) perspectives regarding initiating SGLT2 inhibitors (SGLT2i) in patients with type 2 diabetes and their current and preferred sources of education about SGLT2i and type 2 diabetes pharmacotherapy more generally; and 2) The support provided to PCPs by Endocrinologists in relation to prescription of type 2 diabetes medications.

Methods: Semi-structured interviews were conducted with 15 PCPs and 12 Endocrinologists working in diverse demographic areas in New South Wales, Australia. A purposive approach was used to recruit PCPs and Endocrinologists. Emergent themes were identified from the transcripts. Interviews were conducted until thematic saturation was reached.

Results: We identified factors contributing to some PCPs’ hesitancy to prescribe SGLT2i. These included an under-appreciation of the cardiovascular and renal benefits of SGLT2i, uncertainty about the role of comparatively new drug classes including SGLT2i, a preference for an Endocrinologist to decide on therapy and patients’ experiences with adverse effects. PCPs expressed a preference to receive education about this topic from Endocrinologists, ideally via case-based discussions. Challenges faced by Endocrinologists in providing education to PCPs included potential constraints on talk content imposed by a pharmaceutical company if speaking at a company-sponsored event (focus being on an individual agent), prioritising time for PCP education, and the need to provide support about other endocrine conditions in addition to diabetes. Several Endocrinologists believed that interactive sessions with PCPs were most useful to PCPs, which could occur virtually.

Conclusion: Despite the evidence for the cardio-renal benefits of SGLT2i, there are barriers to PCPs prescribing these agents. Case-based discussions between PCPs and Endocrinologists about type 2 diabetes treatment including the role of SGLT2i are of great value to PCPs.

Disclosure

T. Milder: None. S. Stocker: Consultant; Self; Nutromics. M. Baysari: None. R. O. Day: None. J. Greenfield: None.

Funding

The Heart Foundation (102279)
782-P: Machine Learning to Identify Diabetes Patients Initiating SGLT2i at High-Risk of Acute Kidney Injury
Authors: YANG LANTING , GABRIEL NICO , HERNANDEZ INMACULADA , WINTERSTEIN ALMUT G. , KIMMEL STEPHEN , GUO JINGCHUAN
Published: June 2021

One of the main safety concerns associated with SGLT2 inhibitors (SGLT2i) is the increased risk of acute kidney injury (AKI), likely attributed to their diuretic effect and the induced hypovolemia. Yet, little is known about what patients are at highest risk of developing AKI when using SGLT2is. We applied machine learning techniques to predict AKI in type 2 diabetes (T2D) patients treated with SGLT2i and identify risk factors associated with AKI. Using a 5% random sample of Medicare claim data, we identified 17,694 T2D patients who filled ≥1 prescription for canagliflozin, dapagliflozin or empagliflozin prescriptions between 04/01/2013 and 12/31/2016. The cohort was split randomly and equally into training and testing sets. We measured 65 predictor candidates using claims data from the year prior to SGLT2i initiation and applied 3 machine learning models, i.e., random forests (RF), elastic net, least absolute shrinkage and selection operator (LASSO). The incidence rate of AKI was 1.1 % over a median 1.5-year follow up. Among 3 machine learning methods applied, RF produced the best prediction (C- statistic =0.72 ,95% CI 0.68, 0.76), followed by LASSO (C-statistic=0.69 95% CI 0.65,0.73). Among individuals classified in the top 10% of the RF risk score (i.e., high risk group), the actual incidence rate of AKI was as high as 3.7%. RF and LASSO selected similarly sets of important predictors, such as age, Medicaid eligibility, and loop diuretics use. In the logistic regression including 14 predictors selected by LASSO, use of loop diuretics [adjusted OR: 3.72 (2.44, 5.76)] and history of AKI [adjusted OR: 2.78 (1.06,7.3)] had the strongest associations with incidence of AKI. Our machine learning model efficiently identified patients who are at high risk of AKI after SGLT2i initiation. Strikingly, we identified an almost four-fold increased risk of AKI associated with background loop diuretic use among SGLT2i users.

Disclosure

L. Yang: None. N. Gabriel: None. I. Hernandez: Consultant; Self; Bristol-Myers Squibb Company, Pfizer Inc. A. G. Winterstein: Research Support; Self; Merck Sharp & Dohme Corp. S. Kimmel: Consultant; Self; GE Healthcare, GlaxoSmithKline plc. J. Guo: None.
811-P: Durable Insulin Pumps vs. Multiple Daily Injections for Type 1 Diabetes: Health Care Utilization and A1C
Authors: SHAH MONA , ZHU CYRUS , WHERRY KAEL
Published: June 2021

Objectives: The healthcare utilization benefits associated with insulin pump therapy compared to multiple daily injections (MDI) therapy are not well known. This study sought to compare the impact of using a durable insulin pump versus MDI therapy on healthcare utilization and A1C among individuals with type 1 diabetes (T1D).

Methods: This population-based, longitudinal analysis used a large repository of healthcare claims data to compare diabetes-related and all-cause inpatient admissions (IP) and emergency room (ER) visits in individuals with T1D using durable pumps (N=1,286) versus MDI (N=3,854). The study period was June 1, 2017 to July 31, 2019. The study index date was assigned to the first date of pump use in the pump cohort and a random index date was assigned to the MDI cohort. Continuous insurance enrollment 1-year before and 1-year after adoption/index date was required. Generalized linear model regression was used to test the difference-in-difference effect of therapy type on rates of utilization and A1C. The U.S. Agency for Healthcare Research and Quality (AHRQ) Prevention Quality Indicator (PQI) algorithm was used to define diabetes-related utilization.

Results: Individuals on insulin pump therapy had a significant decrease in IP utilization compared to little change among individuals using MDI therapy (-41% vs. +3%, p=0.01), and similar decreases in ER utilization (-27% vs. -16%, p=0.64). Combining diabetes-related IP and ER utilization, individuals on insulin pump therapy experienced a decrease of 34% compared to decrease of 8% among those using MDI therapy (p= 0.02). Individuals on insulin pump therapy also experienced a larger decrease in A1C (-7% vs. -1%, p=<0.0001).

Conclusions: Compared to MDI therapy, use of a durable insulin pump associated with a significantly smaller increase in diabetes-related healthcare utilization and A1C over time.

Disclosure

M. Shah: Employee; Self; Medtronic. C. Zhu: Employee; Self; Medtronic. K. Wherry: Employee; Self; Medtronic.
825-P: Glycemic Control in Hospitalized Patients Receiving Enteral Nutrition
Authors: HAWKINS R. MATTHEW , SEGGELKE STACEY A. , GIBBS JOANNA , LINDSAY MARK C. , LOW WANG CECILIA C.
Published: June 2021

Objective: The incidence of hyperglycemia in patients receiving enteral nutrition ranges from 34.5-50% and is associated with increased morbidity and mortality. This study examined glycemic control in hospitalized patients receiving enteral nutrition on insulin therapy.

Methods: Admission level data for all adults (18 years or older) admitted to UC Health Central from Jan 1-Dec 31, 2019 treated with insulin while receiving continuous enteral nutrition were included. Patients were stratified by any pre-existing diagnosis of diabetes mellitus (DM) determined from diagnosis codes prior to the admission date. Blood glucose values from point of care testing performed up to 10 days while receiving enteral nutrition and insulin were included.

Results: A total of 662 patients accounted for 789 admissions in 2019 during which enteral nutrition and insulin were received. For each admission, the longest period of continuous tube feeding up to 10 days was selected, for a total of 5443 days for which data are available. Of the 662 patients, 348 (52.5%) had pre-existing DM (mean±SD 61.5±13.1 years) and 314 (47.4%) did not (mean±SD age 58.2 ±15.2 years); 260 (39.3%) were female and 402 (60.7%) were male. The glucose on days 2, 6, and 10 of enteral nutrition and insulin were 168.3±51.9, 160.1±41.1, and 153.4±38.6 mg/dL, respectively (n=621, 426, and 284 for respective days).. The percentage of inpatient days with a blood glucose value < 70 mg/dL in patients without DM was 2.8% vs. 5.3% in patients with DM (p<0.0001).

Conclusion: Mean glucose improved and variability decreased over time in hospitalized patients with or without diabetes on enteral nutrition and insulin therapy, but the mean glucose was within the goal range of 140-180 mg/dL. Patients without a prior diagnosis of diabetes had a lower percentage of inpatient days with a BG < 70 mg/dL. Further analysis is needed to determine optimal insulin dosing strategies and to improve glycemic control in this population.

Disclosure

R. Hawkins: None. S. A. Seggelke: None. J. Gibbs: None. M. C. Lindsay: None. C. C. Low wang: None.
839-P: Impact of Culturally Specific Care Teams on Mitigation of Racial Disparities in Diabetes Care: A Five-Year EHR-Based Study
Authors: ADAM ATIF , LAU KA HEI KAREN , SHAH HETAL , YU MARC GREGORY , KING GEORGE L.
Published: June 2021

Cultural and language barriers are known to reduce the likelihood of Asian-American patients (AA) with diabetes achieving recommended goals for HbA1c, blood pressure, and LDL, known as ‘ABCs of DM.’ Our previous study of an integrated Asian clinic for AA (AAC) at Joslin Diabetes Center, showed more AA patients achieving ABC goals 1-year after their initial visit, than whites in the Adult Diabetes clinic (WDC). AAC staff, including MDs, dietitians, educators, and patient coordinators, are all multi-lingual AAs who offer culturally-tailored management approaches. In a 5-year follow-up study between 2014 to 2019, we examined the clinical performance of new patients with T2D, comparing the following groups: AAC (n=166), AA in Adult Diabetes Clinic (ADC) (n=186), and WDC (n=2993). Compared to WDC and ADC, AAC patients were older (P=0.06), had lower BMI (P<0.001), lower education levels (P<0.001), more likely to be on Medicare (P<0.001), more likely to be non-native English speakers, and had significantly more educator sessions (P<0.001). At the initial visit, AAC patients had similar metabolic profiles as ADC and WDC (P=0.50). At the end of 5 years, 32.0% of AAC patients achieved the ABC goals, compared to 23.7% in WDC and 34.6% in ADC. Across all patients, the odds of meeting ABC goals are significantly higher (P<0.01) by having English as a primary language (OR:1.51; 95% CI: 1.19 - 1.26) and not being on Medicare (OR:1.24; 95% CI: 1.09 - 1.41). After adjusting for these factors, over 5-years of follow-up, the odds of AAC patients meeting ABC goals are similar to WDC patients (OR:0.58; 95% CI:0.25- 2.31, P=0.11) and better than ADC patients (OR:1.30, 95% CI:0.98- 3.22; P=0.06). Despite the financial, language, and educational disadvantages, AAC patients have achieved similar ABC targets as WDC and ADC patients. These findings suggest that culturally-specific care for AA can mitigate healthcare disparity in T2D management and can be maintained over prolonged periods of time.

Disclosure

A. Adam: None. K. Lau: None. H. Shah: None. M. Yu: None. G. L. King: Consultant; Self; Agios, Inc., Medtronic, Other Relationship; Self; Janssen Pharmaceuticals, Inc.
845-P: Unmanaged Diabetes as a Poor Prognostic Factor in the Severity of Infection and Recovery Time of Hospitalized COVID-19 Patients
Authors: MOSSAYEBI ALI , KREIT HELEN , CHERUKURI SUNDAR V. , MANDANIA ROSHNI A. , CONCHA JEANNIE B. , JUNG HYEJIN , WAGLER AMY E. , GUPTE AKSHAY A. , DEOKER ABHIZITH , BAJPEYI SUDIP
Published: June 2021

Diabetes is considered as one of the comorbidities with COVID-19 infection and indicated to influence the severity and the rate of recovery in COVID-19 patients. However, it is not known whether the lack of diabetes management may magnify COVID-19 severity and the rate of recovery in patients with diabetes.

Purpose: The purpose of this study was to determine the effect of diabetes management on the severity and length of hospitalization in hospitalized COVID-19 patients.

Methods: This retrospective study used medical records from patients admitted to the University Medical Center, El Paso, TX with COVID-19 (n=369; Age 60.0 ± 0.8 years; BMI 30.3 ± 0.4 Kg/m2). Glycemia was assessed by glycated hemoglobin (A1c) level at the time of hospitalization. The severity of the COVID-19 outcome was assessed by quick sepsis-related organ failure assessment (qSOFA) and length of hospitalization was determined by the number of days spent in the hospital. Patients were categorized into normoglycemic (N: A1c <5.7%), prediabetes (Pre: 5.7% ≤ A1c < 6.5%), and diabetes mellitus (DM: A1c ≥ 6.5%) groups. DM group was further categorized for diabetes management with medication. One-way ANOVA and unpaired t-test were used to determine the statistical differences among/between groups as appropriate.

Results: There was no significant difference among groups in severity of COVID-19 infection (qSOFA: N 0.24 ± 0.08, Pre 0.38 ± 0.07, D 0.28 ± 0.03; p>0.05) and length of hospitalization (N 5.6 ± 0.8, Pre 9.3 ± 1.0, DM 8.9 ± 0.6 days; p>0.05). However, patients with unmanaged diabetes (no medication) showed significantly greater severity (qSOFA: 0.44 ± 0.08 vs. 0.22 ± 0.03; p<0.05) and length of hospitalization (10.8 ± 1.6 vs. 8.2 ± 0.6 days; p<0.05) compared to patients who managed diabetes with medication.

Conclusion: Unmanaged diabetes shows worsened severity and the rate of recovery in COVID-19 patients. Diabetes management should be considered in the treatment of COVID-19 patients.

Disclosure

A. Mossayebi: None. S. Bajpeyi: None. H. Kreit: None. S. V. Cherukuri: None. R. A. Mandania: None. J. B. Concha: None. H. Jung: None. A. E. Wagler: None. A. A. Gupte: None. A. Deoker: None.
846-P: Basal Insulin Management in Inpatients Who Are Not Eating: Is There a Difference between Medical and Surgical Patients?
Authors: SACDAL JOHN PAUL , HABIB HELEN A. , CHEON EUNAH , OH ERIN
Published: June 2021

Background: Guidelines from the 2021 American Diabetes Association recommend basal or basal plus correctional insulin dosing for non-critically ill hospitalized patients with poor oral intake or are nil per os (NPO). The recommended adjustment is 75-80% of long-acting basal insulin administered perioperatively. The aim of this study was to build on the current data available to determine the optimal management of insulin detemir dosing between medicine and surgery patients who were unable to eat.

Methods: This was a retrospective single-center observational study between January and December 2019 that included patients with type 2 diabetes and confirmed NPO status receiving insulin detemir. To determine best practices of long-acting insulin management, 100%, 80-33%, and 0% insulin detemir dosing in medical and surgical patients were evaluated. The primary endpoint was incidence of hypoglycemia (<70 mg/dL) after insulin dose adjustment. Secondary endpoints were incidence of severe hypoglycemia (<40 mg/dL) and hyperglycemia (>180 mg/dL) after insulin dose adjustment.

Results: Of the 100 adult patients who met the criteria, there were no incidences of hypoglycemia or severe hypoglycemia regardless of insulin detemir dose adjustment in either medical or surgical patients. In the medicine group, hyperglycemia occurred in 23/67 (34.3%), 2/6 (33.3%), 4/12 (33.3%) for 100%, 80-33%, and 0% insulin dose adjustments, respectively. In the surgery group, hyperglycemia occurred in 8/12 (66.7%) in patients receiving 100% insulin detemir dosage with no notable outcomes in the remaining 3 patients.

Conclusions: There was no incidence of hypoglycemia or severe hypoglycemia between medical and surgical patients, regardless of insulin detemir dose adjustment. A numerically higher incidence of hyperglycemia was observed in patients receiving 100% insulin detemir in both medicine and surgery patients. Further education is planned to reduce hyperglycemia.

Disclosure

J. Sacdal: None. H. A. Habib: None. E. Cheon: None. E. Oh: None.
847-P: Goal-Setting Behavior for Physical Activity in Diabetics: A Quality Improvement Project
Authors: NGUYEN-VASELAAR HANH T.
Published: June 2021

Low levels of physical activity are strongly associated with increased mortality and numerous health issues which increase health care costs. Diabetes is one disorder that is known to require physical activity for the best control of symptoms. Use of SMART (Specific, Measurable, Attainable, Relevant, Time-bound) goals is one approach to assist patients with behavioral changes. They are of little to no cost to patients and help integrate the patient as an active participant in the health care plan. Patients set their own goals, and the health care team provides coaching. In this quality improvement project, we introduced SMART Goals as a patient-centered, self-motivating strategy to increase type II diabetics’ physical activity and thereby decrease their HbA1c (hemoglobin A1c) levels. Coaching was done via telephone for 3 to 4 months. We assessed pre- and post-intervention physical activity levels and gathered HbA1c at routine diabetic follow ups. A total of 29 participants were enrolled in the study, six were lost to follow up. Although no changes were statistically significant in this small sample, the final cohort of 23 patients generally showed an increase in walking and moderate physical activity, a decrease in self-reported sedentary behavior, and overall improvement in HbA1c. On average, greater HbA1c improvements were seen in patients who met their activity goal and change in physical activity level was positively correlated with reduced HbA1c. Findings suggest that HbA1c improvements and increased physical activity levels are possible if patients are encouraged to set actionable SMART goals. This approach can be applied to any clinical setting and could help motivate patients to increase their physical activity levels.

Disclosure

H. T. Nguyen-vaselaar: None.
849-P: Outreach Method Predicts Patient Engagement during Sustained Care Disruption
Authors: CROMWELL GRACE , HUDSON MARGO , MCKITRICK CHARLES K. , DONAHUE MARINA , SMITH COLLEEN M. , FOWLER KRISTEN M. , DEL VALLE KAYLA L. , SIMONSON DONALD C. , MCDONNELL MARIE E.
Published: June 2021

The COVID-19 pandemic has caused sustained disruptions in access to usual diabetes care. In response to the high number of cancelations, an academic, urban diabetes program transitioned to virtual visits and launched an initiative to provide outreach to patients who canceled an appointment between Mar 16 and Jun 19, 2020. Members of the diabetes team used a standardized approach to prevent delayed care or disengagement. Method of contact was defined as Reached (two-way communication between clinician and patient by phone or EHR portal message), Message Left (e.g., voicemail) and No Contact. Engagement was defined as booking a follow up appointment and keeping the appointment. A total of 787 patients were determined to have canceled visits due to the pandemic. Mean (SD) age was 61.7 yrs (14.2), 53.7% female, 67.3% white, baseline A1c 7.96% (1.81). Of the 648 visits booked, 519 (80%) were kept. Patients who were reached were more likely to book (OR = 2.43, p<0.001) and keep an appointment (OR = 2.39, p<0.001) compared to no contact or message left. Older age was a significant predictor of booking (OR = 1.014 for each year older, p=0.037). Patients on insulin were more likely to keep their appointment (OR = 1.70, p=0.008), while patients with higher HbA1c were less likely to (OR = 0.87 for each 1.0% increase in HbA1c, p=0.011). These findings suggest that for systems designed to optimize engagement during care disruption, one-way communication is no better than no contact, and two-way communication increases the likelihood that patients will maintain access to care. In addition, while higher risk patients (e.g., older age or on insulin) may be more incentivized to stay engaged, targeted outreach may be needed for those with chronic poor glycemic control.

Disclosure

G. Cromwell: None. M. Hudson: None. C. K. Mckitrick: None. M. Donahue: None. C. M. Smith: None. K. M. Fowler: None. K. L. Del valle: None. D. C. Simonson: Stock/Shareholder; Spouse/Partner; Phase V Technologies, Inc. M. E. Mcdonnell: Stock/Shareholder; Spouse/Partner; Abbott Diabetes.
858-P: Online Clinician and Aligned Patient Education Improves Both Clinicians’ and Patients’ Ability to Manage T2D with GLP-1 RAs
Authors: LARKIN AMY , LE ANNE
Published: June 2021

We sought to measure the impact of aligned, online education for clinicians and patients on knowledge and real-life changes. For clinicians, a live-streamed virtual symposium was held as part of the Metabolic and Endocrine Disease Summit (MEDS) Fall meeting in October 2021. Pre/post questions assessed changes in knowledge and practice. For patients, an online activity was comprised of text, integrated visuals, and a clinician commentary. Demographic questions were asked prior to the education. A pre/post knowledge question assessed learning gains. Intent to change and confidence questions were asked at the end. Absolute improvements were calculated for pre/post questions. The patient activity launched in June and data collected through November. Clinician Activity: Of 464 learners: 41% were nurse practitioners, 19% physician assistants, and 19% physicians; 32% specialized in diabetes and 20% in family medicine; 22% see 11-20 patients with T2D per week and 21% see greater than 30 per week. Increased knowledge was observed in patient education related to how to appropriately take an oral GLP-1 RA. 58% reported an animation video demonstrating the mechanism of action of a new oral GLP-1 RA to be very helpful in increasing their clinical knowledge. After the education, 47% reported being confident in patient selection for GLP-1 RA therapy, demonstrating a need for more education on this topic. Patient Activity (“Tips for Taking GLP-1 RAs for T2D?"): To date, 13,237 learners. Knowledge changes: 42% improvement in recognizing how you should take an oral GLP-1 RA (45% pre to 87% post). Intent-to-act: 66% plan to talk to their HCP about if an oral GLP-1 RA is right for them. Confidence changes: 73% reported increased confidence in taking a GLP-1 RA so it’s easier and has less side effects. The metrics and outcomes gathered in this assessment are a strong indicator that aligned clinician and patient activities are successful at improving ability to manage T2D with GLP-1 RAs.

Disclosure

A. Larkin: None. A. Le: None.

Funding

Novo Nordisk
86-OR: Primary Results from Two Phase 3 Trials of Faricimab for Diabetic Macular Edema (DME): YOSEMITE and RHINE
Authors: HU ALLEN , WILLIS JEFFREY R. , HASKOVA ZDENKA , SILVERMAN DAVID , IVES JANE , BASU KAREN , LIN HUGH
Published: June 2021

The leading cause of vision loss in people with diabetic retinopathy (DR) is DME. Intravitreal anti-VEGF therapy is the standard of care for DME; however, optimal vision outcomes are difficult to achieve, and the need for ongoing, often monthly injections is burdensome for patients, caregivers, and the health care system. Upregulation of both VEGF-A and angiopoietin-2 has been shown to synergistically induce vascular destabilization characteristic of DME; therefore, dual inhibition with faricimab, the first bispecific antibody designed for intraocular use, may improve outcomes beyond anti-VEGF monotherapy. YOSEMITE (NCT03622580) and RHINE (NCT03622593) are identical, randomized, phase 3 trials to assess the efficacy, durability, and safety of faricimab in DME. Patients were randomized 1:1:1 to faricimab 6.0 mg every 8 weeks (Q8W) after 6 initial Q4W doses; faricimab 6.0 mg per personalized treatment interval (PTI) after 4 initial Q4W doses; or aflibercept 2.0 mg Q8W after 5 initial Q4W doses. Dosing intervals in the PTI arm were adjusted based on treatment response using prespecified vision and anatomic criteria. Safety and efficacy will be assessed Q4W through week 100. The primary endpoint was mean change in best-corrected visual acuity at 1 year, averaged over weeks 48, 52, and 56. Secondary endpoints included changes in anatomic outcomes over time, such as DR severity and central subfield thickness; and the proportion of patients on Q4W, Q8W, Q12W, or Q16W PTI dosing at 1 year. Safety endpoints were the incidence and severity of adverse events. Both studies met their primary endpoint and showed that faricimab dosed Q8W or per PTI demonstrated non-inferior visual acuity gains compared to aflibercept Q8W. More than half of all patients in the faricimab PTI arms had extended time between treatments to 16 weeks at 1 year - the first time this level of durability has been achieved in a phase 3 DME study. Faricimab was generally well-tolerated, with no new safety signals identified.

Disclosure

A. Hu: Advisory Panel; Self; Roche Pharma. J. R. Willis: Employee; Self; Genentech, Inc., Stock/Shareholder; Self; Roche Pharma. Z. Haskova: Employee; Self; Genentech, Inc. D. Silverman: Employee; Self; Roche Pharma. J. Ives: Employee; Self; Roche Pharma. K. Basu: Employee; Self; Genentech, Inc., Roche Pharma, Stock/Shareholder; Self; Genentech, Inc., Roche Pharma. H. Lin: Employee; Self; Genentech, Inc., Employee; Spouse/Partner; Genentech, Inc.

Funding

F. Hoffmann-La Roche, Ltd.
869-P: Patient-Provider Video Visit Use and HbA1c Control among Patients with Diabetes
Authors: REED MARY , GOPALAN ANJALI , GRAETZ ILANA , HSUEH LORETTA , HUANG JIE , MUELLY EMILIE
Published: June 2021

Video telemedicine can offer patients direct real-time convenient access to clinicians without arranging transportation or work time-off, improving access to diabetes care and self-management support. We examined the association between video visit use and hemoglobin A1c (HbA1c) among patients with diabetes.

In a longitudinal study, within a large integrated delivery system where patients were first able to self-schedule real-time physician video visits in 2016, we used the clinical registry to identify patients with diabetes (2015), and followed their video visit use and subsequent HbA1c values over time (2016-2019). Using linear regression with patient-level fixed effects (within-patient changes), adjusting for calendar year and month and time-changing patient mobile portal access, we measured the association between use of video visits as a time-changing variable and the patient’s yearly HbA1c values (in subsequent calendar years after video visit use). We then stratified analyses by baseline HbA1c value: <8%, ≥8%, no value (defined as lower patient engagement).

Among 204,301 patients with diabetes, 50% were 65 years or older, 48% were women, and 45% were of white race/ethnicity. Overall, 95% of patients had a baseline HbA1c value, 24% had HbA1c values ≥8%. Patient use of video visits was associated with an overall statistically significant reduction in HbA1c value by 0.15% (95% CI: 0.11%-0.19%). Among those with baseline HbA1c values ≥8%, using video visits was associated with a HbA1c value reduction of 0.22% (95% CI: 0.12%-0.32%), and among patients with lower baseline engagement (i.e., no baseline HbA1c measurement), using video visits was associated with a HbA1c reduction of 0.39% (95% CI: 0.07%-0.71%).

Use of video visit was associated with improved glycemic control among patients with diabetes, with greater improvements found among patients with worse baseline control and lower engagement. Video visits may offer convenient health care access to improve diabetes management.

Disclosure

M. Reed: None. A. Gopalan: None. I. Graetz: None. L. Hsueh: None. J. Huang: None. E. Muelly: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (R01DK085070)
870-P: Patient Factors and Engagement of Care in Type 2 Diabetes in Phnom Penh, Cambodia
Authors: VICENCIO JASMINE M. , PENG SOVANN , MENH PHANAVARINE , CURRAN PETER G. , HUDSON MARGO
Published: June 2021

Cambodia is developing its response to non-communicable diseases including the increasing prevalence of diabetes. Third party payment for care is limited therefore much of the financial burden is left to the patient. The Community Medical Center (CMC) is an NGO-sponsored outpatient clinic in Phnom Penh which started a diabetes specialty clinic in 2013 in the absence of endocrinologists by relying on a corps of internists. This corps plays a critical role in monitoring and treating patients over time given the chronic nature of the disease. Multiple visits annually are considered standard of care in the developed world. The CMC team launched a database tracking all patients in 2015 and had enrolled 3634 patients with T2DM as of January, 2019. Complete data sets were available for 3570. We performed a fixed effects regression analysis to identify patient characteristics at the initial visit that might impact engagement in care (ENC), defined as fully engaged if patient had at least 2 follow-up visits within the first year of enrollment (FENC), or partially engaged (one f/u visit) PENC. Of the patients enrolled, 2,019 met criteria for FENC, 420 met criteria for PENC, and 1,131 were not engaged. In a fully adjusted model, receiving financial assistance for health expenses had the greatest impact (β = 0.382, p<.001) on ENC. Taking antihypertensive medication was also associated with ENC (β = 0.141, p<.001). BMI > 35 was negatively associated with ENC (β = -0.280, x p<.05). Proximity of residence to CMC, presence of complications, A1C level, and use of insulin were not significantly associated with ENC. This is the first large longitudinal study of its type in Cambodia. Assistance with cost of care to the patient had the strongest positive correlation with ENC. Further research is needed to better understand the factors that lead to ENC in resource challenged environments such as Cambodia as well as guide what modifications can be made to programs.

Disclosure

J. M. Vicencio: None. S. Peng: None. P. Menh: None. P. G. Curran: None. M. Hudson: None.

Funding

Peco Foundation
876-P: Is Telemedicine the Preferred Visit Modality in Patients with Type 1 Diabetes?
Authors: KIRZHNER ALENA , ZORNITZKI TAIBA , OSTROVSKY VIVIANA , KNOBLER HILLA , SCHILLER TAL
Published: June 2021

Background: The COVID-19 pandemic limits access to diabetes clinics. Remote communication by phone calls and WhatsApp messages became available in the past years. However, the current need to avoid face-to-face meetings necessitates further expansion of telemedicine services. There are limited data whether the option of virtual meetings is a preferred therapeutic modality for patients with type 1 diabetes (T1D).

Objective: To assess in a cohort of T1D patients, their preference and perception of telemedicine.

Methods: T1D patients who are followed in a hospital-affiliated diabetes clinic were asked to fill a structured questionnaire aimed to determine their attitude towards telemedicine and their preference of virtual versus conventional visits. The questionnaire was offered to consecutive T1D patients who visited the clinic between August to October 2020.

Results: Seventy one T1D patients that fulfilled the questionnaire were included. Mean age was 42±15 years, 39% were male, and the mean duration of diabetes was 21±14 years. Fourteen percent of the participants preferred only virtual visits, 24% only conventional visits and 62% preferred a combination of these modalities. Sex, origin, education, duration of diabetes, mode of insulin treatment and distance from the clinic were not associated with patients’ preference, but older patients (≥ 61 years) tended to prefer conventional visits. Sixty-seven percent felt confident in their ability to download data from their personal medical devices.

Conclusions: Patients from a wide range of treatment modalities are willing to use telemedicine. However, virtual meetings cannot fully replace conventional visits in T1D especially in the older age group.

Disclosure

A. Kirzhner: Speaker’s Bureau; Self; Novo Nordisk. T. Zornitzki: Speaker’s Bureau; Self; Novo Nordisk. V. Ostrovsky: None. H. Knobler: None. T. Schiller: Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk Inc.
877-P: Video Visit: A New Tool for Diabetes Post-hospitalization Follow-up
Authors: KARSLIOGLU-FRENCH ESRA , SISTLA DIVYA , MEYER ANNA C.
Published: June 2021

Background: UPMC Diabetes Inpatient Service has been offering follow-up appointments to patients in endocrine clinic one week after discharge as an intervention to decrease readmissions. Unfortunately, these appointments have a very high no show rate and are only offered to a select group of patients who can show up to clinic in person. During COVID19 public health emergency as CMS started to reimburse video visits, our clinic switched to offer video visits one week following hospital stay. Whether video visits are effective for post-hospital follow-up is not known.

Objective: The aim of this study is to understand the impact of post-hospital video visits in diabetic population outcomes and clinic utilization.

Methods: We completed a retrospective chart review of patients with diabetes who had a follow-up appointment one week after discharge in 2019(August, September and October) and 2020(August, September and October). We compared no-show rates, utilization of physicians versus APPs, reduction in A1c between two groups.

Results: August to November 2019, 42 office appointments were scheduled. 24/42 appointments were completed, and the no show rate was at 42%. Previsit (hospital) average A1c was 8.03%, which improved to an average of 7.4% 3 months following appointment. 92% of all appointments were completed by physicians, and 8% were completed by an APP. August to November 2020, 100 posthospital appointments were scheduled for diabetes service patients. 70 of 100(70%) agreed to complete video visits, 29/100 preferred office appointments. In video visit group, no show rate was only (8/70) 11%. Video visit group had a previsit (hospital) average A1c: 8.3%, 3 months after video visit average A1c improved to 6.3%. 32% of post-discharge visits were completed by a physician, 67% of were completed by an APP.

Conclusion: In patients with diabetes, post-discharge video visits decreased no show rates, increased utilization of APPs while achieving to improve A1c.

Disclosure

E. Karslioglu-french: None. D. Sistla: None. A. C. Meyer: None.
88-LB: Kidney and Metabolic Benefits by Adding GLP-1 Agonists and/or SGLT2 Inhibitors on Metformin in Obese Type 2 Diabetes (T2DM) Patients: 24-Month Real-World Data from Both Urban and Rural Clinics
Authors: ZOUPAS IOANNIS , PAPAZAFIROPOULOU ATHANASIA , XENOU MARIA , LYGNOS DIMITRIOS , FOUSTERIS EVANGELOS
Published: June 2021

Objective: Assessment of the nephro-metabolic effects of GLP-1 agonists (Group A), SGLT-2 inhibitors (Group B) and both (Group C) in obese patients under metformin therapy with inadequate glycemic control.

Materials and Methods: 253 patients with T2DM on metformin with a HbA1c > 7.0%.

Results: Group A: reduction of HbA1c at 5.9±0.4% (95% C.I. of difference 1.63-3.03, p<0.001), reduction in body weight 7.1±5.5Kg (95% C.I. 4.98-9.26, p<0.001), ALT (mg/dL) reduced by 8.7±3.1, (p=0.04), reduction of Urine Albumin to Creatinine Ratio (UACR) by 25.0±40.8 (p=0.003) and increase of the estimated GFR (CKD-EPI formula) by 10.4±10.6, (p<0.001). Group B: reduction of HbA1c at 6.26±0.42% (95% C.I. of difference 0,59- 1.04 (p<0.001), reduction in body weight by 3.9±2.2Kg (95% C.I. 2.93-4.89 p<0.001), ALT reduced by -9.6±17.3 (p=0.02), UACR reduction by 36.2±70.2 (p=0.025) and eGFR increase 4.2±14.0 mL/mgCreat (p=0.18). Group C: major reduction of HbA1c by 1.9±1.0% (95% C.I. 1.10-2.09, p<0.001), body weight reduction by 10.6±5.7Kg 995% C.I. 7.97-13.28 p<0.0010, ALT reduction by -15.9±14.8 (p=0.04), UACR reduction by -29.9±31.9 (p<0.001) and eGFR increase by 8.3±10.5 (p=0.002).

Conclusions: Triple combination therapy with metformin - GLP1-analog - SGLT2-inhibitor has the greatest effectiveness in weight loss and in improving liver biochemistry. The renal improvement seen with these drugs appears to be driven by a decrease in UACR for SGLT-2-inhibitors and an increase in eGFR for GLP1-analogues in this retrospective 24-month study.

Disclosure

I. Zoupas: None. A. Papazafiropoulou: None. M. Xenou: None. D. Lygnos: None. E. Fousteris: None.
911-P: New-Onset Diabetes and Cerebellar Ataxia in a Child: What Does GAD-65 Have to Do with It?
Authors: CHAN KAREN , SWEAT MARIE , ZIMBRIC MICHAEL R. , NEWFIELD RON S.
Published: June 2021

Glutamic acid decarboxylase isotype 65 (GAD-65) antibodies have been associated with several conditions including type 1 diabetes (T1D), stiff-man syndrome and autoimmune cerebellar ataxia. GAD-65 antibody-associated cerebellar ataxia has been described in multiple case reports, mostly in adult women, but rarely in children, as reported here.

An 11-year-old female presented with two weeks of polyuria and polydipsia and one week of abnormal speech and difficulty walking. Labs were consistent with new onset diabetes with mild ketoacidosis. Neurological exam localized her lesion to the cerebellum. Several type 1 diabetes-related antibodies were positive, including zinc transporter 8, GAD-65, and ICA512. Insulin autoantibody was negative. Serum Pediatric Autoimmune Central Nervous System Disorders Evaluation (Mayo Clinic) showed only elevated levels of GAD-65 antibody to 41.6 nmol/L (≤ 0.02). CSF studies showed oligoclonal bands, without evidence of infection. CSF GAD-65 antibody testing (Mayo Clinic) was elevated to 13.7 nmol/L (≤ 0.02). MRI showed no cerebellar pathology. Thyroglobulin and thyroid peroxidase antibodies were normal. Because of the constellation of findings, she was diagnosed with GAD-65 antibody-associated cerebellar ataxia. Her symptoms improved after a short course of steroids and IVIG. She is planned for monthly IVIG for at least 6 months.

Elevated serum GAD-65 antibody levels are found in the majority of patients newly diagnosed with T1D. GAD-65 CSF levels are noted to be higher in patients that develop autoimmune cerebellar ataxia, stiff-man syndrome or autoimmune polyendocrine syndromes (≤20 nmol/L), as seen in this patient (41.6 nmol/L). Patients presenting with new onset T1D and cerebellar ataxia should prompt evaluation for GAD-65 antibody-associated cerebellar ataxia.

Disclosure

K. Chan: None. M. Sweat: None. M. R. Zimbric: None. R. S. Newfield: Consultant; Self; Merck Sharp & Dohme Corp.
918-P: Predicting the Onset of APECED Diabetes
Authors: PALDANIUS PAIVI M. , MAKITIE OUTI , LAAKSO SAILA
Published: June 2021

Background: Autoimmune polyendocrinopathy-candidiasis-ectodermal dystrophy (APECED) is a rare monogenic autosomal recessive disorder and diabetes (DM) one of its rare and less studied manifestations. Determinants of time to onset and clinical progression to DM seem currently unpredictable.

Materials and Methods: We explored change in pre-diagnosis (dg) glycemic parameters (glucose, insulin, C-peptide), including 60’ intravenous glucose tolerance tests (ivGTT) and homeostasis indices (HOMA-β, -IR) over 20 years (y) with descriptive statistics. Fractional glucose turnover rate (KG) during ivGTT was calculated as 0.693/T1/2Gluc*100 with Pearson correlation coefficient (r) and 2-sided p value.

Results: Between 1972 and 1996, 68 ivGTTs were conducted in 13 pediatric and adult individuals with APECED and DM. The mean age (SD) at DM dg was 27.78y (11.73) among those 22% of our cohort (n=100) with DM. Including one man with ‘latent DM’, with no clinical DM symptoms 20y post-dg. HbA1c was rarely measured, fasting plasma glucose (FPG) values were normoglycemic prior and up to DM dg: mean (SD) FPG 4.4 (0.6) mmol/l (-20y to -6 months [m]) and 5.7 (0.9) mmol/l (<6m to dg). Mean 60’ glucose values were only elevated for those with <6m to dg: 12.1 (0.7) mmol/l. Hyperinsulinemia was present 5-20y prior to dg while rapid 1st phase insulin secretion (combined 1+3 min value; normal >46 mIU/ml) was lost or delayed in some, but not all, 5y prior to dg. Up to and at dg, adequate fasting insulin (>2 mIU/ml) and C-peptide (>0.5 ng/ml) production was observed in most (85%) patients. KG displayed intra- and inter-individual variability, was normal (>1.2%/min) in latent DM, while it predicted DM onset over time (-20y to dg): r= -0.568 (p= 4E-06). Neither HOMA indices were sensitive enough to detect any change over time.

Conclusion: Identification of reduced glucose removal rate over time, indicative of increased peripheral insulin resistance in the presence of pre-diagnostic hyperinsulinemia, provides first insights into progression of atypical diabetes in APECED patients.

Disclosure

P. M. Paldanius: Consultant; Self; UPM Biomedicals, Speaker’s Bureau; Self; Novartis AG. O. Makitie: None. S. Laakso: None.
922-P: Experiences and Difficulties in Transitioning from Pediatric to Adult Diabetes Clinical Care
Authors: LORTON ELEANOR G. , YOUNGKIN ERIN M. , MAJIDI SHIDEH
Published: June 2021

Young adults with type 1 diabetes (T1D) undergoing transfer from pediatric to adult care are at an increased risk of acute and chronic health complications due to challenges associated with transitioning healthcare. This study aims to highlight patient-focused areas of improvement that could be used to optimize transition of care.

Thirteen patients with T1D between ages 17-25 who had completed a pediatric transfer visit and had an adult diabetes appointment scheduled or completed were randomly selected to complete a telephone questionnaire that included open-ended questions regarding experiences transitioning to adult diabetes care. Interviews were analyzed for themes.

Thirteen young adults with T1D (Mage 22.8 ± 1.5 years; Mduration 13.0 ± 5.4 years; 46% female; 69% private insurance; 69% Caucasian, 23% Hispanic, 8% “Other”) completed the interview. Two primary themes emerged regarding “the easiest part of transfer”: streamlined process (77%) and clinic familiarity (23%). Three themes related to transition challenges were: provider compatibility (31%), lack of guidance (23%), and difficulty changing providers (23%). In those who suggested areas of improvement, two main themes emerged: distance to clinic (23%) and scheduling (15%). Patients described three support systems themes (family, significant other, friend) and three themes of support type (financial, emotional, and diabetes-care related).

The majority of patients highlighted that a streamlined process and previous familiarity with the clinic made transferring care easier, while provider compatibility and lack of guidance in the transfer process were barriers. This may indicate areas where pediatric providers can help improve the transfer to adult care. Young adults also highlighted the continued need for financial, emotional, and diabetes-care support as they transition care. These findings are valuable considerations for creating a patient-centered and effective transition program.

Disclosure

E. G. Lorton: None. E. M. Youngkin: None. S. Majidi: Advisory Panel; Self; Companion Medical.