bluuebunny/crossref_metadata_2025_split huggingface dataset:
1150-P: Empagliflozin Decreases the Plasma Concentration of Plasminogen Activator Inhibitor-1 (PAI-1) in Patients with Type 2 Diabetes: Association with Improvement of Fibrinolysis
Authors: NIITANI TAKAFUMI , SAKURAI SHINTARO , JOJIMA TERUO , IIJIMA TOSHIE , TOMARU TAKUYA , USUI ISAO , ASO YOSHIMASA 
Published: June 2020

Objectives: Elevation of the plasma concentration of plasminogen activator inhibitor-1 (PAI-1), a rapid-acting inhibitor of fibrinolysis, is associated with development of cardiovascular diseases. We investigate the effects of empagliflozin, an SGLT2 inhibitor, on the plasma concentration of PAI-1 and fibrinolytic activity in patients with type 2 diabetes.
Methods: In a randomized, active-controlled, open-label trial, 51 patients with type 2 diabetes were randomly allocated at a 2:1 ratio to receive empagliflozin (10 mg/day, n=31) or standard therapy (n=18) for 12 weeks. We measured the plasma concentrations of PAI-1 and plasmin-α2-antiplasmin complex (PAP) as indicators of fibrinolytic activity. Serum leptin and HMW adiponectin were also measured.
Results: Body weight and visceral fat decreased in the empagliflozin group, but not in the control group. The serum level of γ-GTP showed a significant decrease at 12 weeks in the empagliflozin group, while it was unchanged in the control group. Serum HMW adiponectin increased significantly in the empagliflozin group. Plasma PAI-1 decreased significantly by 25% in the empagliflozin group, but not in the control group. In the empagliflozin group, the change of plasma PAI-1 was positively correlated with the changes of body weight and leptin, but was negatively correlated with the change of PAP.
Conclusions: Empagliflozin reduced the plasma PAI-1 concentration through its synergistic actions of a glucose-lowering effect, weight loss, and restoring the adipokine balance. The beneficial effects of empagliflozin on fibrinolysis by decreasing circulating PAI-1 may be associated with improvement of vascular thrombotic outcomes in patients with type 2 diabetes. (Clinical trial registry: UMIN000025418).

Disclosure
T. Niitani: None. S. Sakurai: None. T. Jojima: None. T. Iijima: None. T. Tomaru: Research Support; Self; Merck & Co., Inc., Teijin Pharma Limited. I. Usui: None. Y. Aso: None.
1151-P: A Cost-Effectiveness Analysis of Charcot Reconstruction, Transtibial Amputation, and Lifetime Bracing for Adults with Midfoot Charcot Arthropathy
Authors: FLEISCHER ADAM E. , ALBRIGHT RACHEL H. , ARMSTRONG DAVID G. , WUKICH DANE 
Published: June 2020

Background: The optimal therapeutic approach for people suffering with unstable Charcot arthropathy of the midfoot is unclear. The purpose of this study was to examine the cost-effectiveness of three competing treatment strategies for adults suffering with unstable, midfoot Charcot arthropathy.
Methods: A Markov model was utilized to compare Charcot reconstruction (CR), primary transtibial amputation (TTA) and lifetime bracing in three progressively worsening clinical scenarios: no foot ulcer, uncomplicated ulcer, and infected ulcer. Data regarding costs and probabilities were obtained from available literature. Primary outcomes included long-term costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs). Willingness-to-pay was set at $100,000 USD.
Results: TTA failed to show cost-effectiveness in comparison to other strategies available. Lifetime bracing was cost-effective in all clinical scenarios, with ICERs ranging from $6,970 to $15,010. CR was also cost-effective in the non-ulcerated and ulcerated scenarios, and offered the greatest potential for maximal QALYs gained, but failed to show value in the infected ulcer scenario. For CR to be cost-effective in the infected ulcer scenario, costs of surgery would need to lessen to $40,000 or complication rates would need to remain under 50%. The results in the non-ulcerated and ulcerated cohorts were robust to multiple sensitivity analyses.
Conclusion: Bracing is a cost-effective option in all stages of Charcot arthropathy while CR appears to be only cost-effective when performed early (i.e., in the non-ulcerated and uncomplicated ulcerated patient). An opportunity for shared-decision making exists in the early stages of Charcot arthropathy, where patient goals and expectations may be assessed while multiple cost-effective options are still available.

Disclosure
A.E. Fleischer: None. R.H. Albright: None. D.G. Armstrong: None. D. Wukich: Consultant; Self; Orthofix, Wright Medical. Other Relationship; Self; Arthrex.
1153-P: National Trend in Out-of-Pocket Burden in Adults Aged 18–64 Years with Diabetes: 2001-2017
Authors: WANG YU , PARK JOOHYUN , LI RUI , LUMAN ELIZABETH , ZHANG PING 
Published: June 2020

Recent changes in health coverage benefits and increases in diabetes medication prices may have affected out-of-pocket (OOP) expenditures for people with diabetes. High OOP expenditures is a barrier to get adequate medical care. We assessed national trends in OOP expenditures overall and by OOP-component among adults aged 18-64 years with diabetes from 2001 to 2017 using data from the U.S. Medical Expenditure Panel Survey. OOP expenditures were defined as the amount paid by a family with one or more members with diabetes, including insurance premiums, deductions, copays, coinsurance and payments not covered by insurance. High OOP burden was defined as spending &gt;10% of the family’s pretax income on OOP expenditures. We examined trends overall as well as by insurance type, income (as a ratio of federal poverty level, FPL), type of service, and whether patients used insulin. We tested for changes in trends using joinpoint analysis. OOP expenditures were adjusted to 2017 U.S. dollars. From 2001 to 2017, OOP expenditures decreased 4.3%, from $4328 to $4139, and the percentage of persons with high OOP burden fell 32%, from 28% to 19% (P&lt;0.001). No significant changes in trends were identified for either measure. Both OOP expenditures and percentages with high OOP burden declined for those with public or no insurance and those with family income &lt; 200% of FPL (P&lt;0.001). There were increases in OOP expenditures (P&lt;0.001) but no significant changes in percentages with high OOP burden for those with private insurance and those with income ≥ 400% of FPL. OOP expenditures on prescriptions decreased for all insurance types and income subgroups (P&lt;0.001). Decreases in total (-$58 vs. -$37, P&lt;0.001) and prescription (-$79 vs. -$68, P&lt;0.001) OOP expenditures were larger for insulin users than non-users. These most recent data show that OOP expenditures for U.S. adults with diabetes are steadily declining, especially for those least able to afford them. Future studies are needed to explain these patterns.

Disclosure
Y. Wang: None. J. Park: None. R. Li: None. E. Luman: None. P. Zhang: None.
1159-P: Cost of Achieving A1C Treatment Goals in Patients with Type 2 Diabetes: Results from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial
Authors: ZHANG PING , SHAO HUI , BERTONI ALAIN , LOVATO LAURA , CHEN HAIYING 
Published: June 2020

American Diabetes Association (ADA) guideline on glycemic control recommends an A1c &lt;7% in most adults with diabetes and 7-8% for those with history of hypoglycemia, limited life expectancy, or comorbid conditions. From 2013-2016, 64% of U.S. adults with diabetes met ADA A1c goals. Using data from the ACCORD trial, we estimated the cost of achieving the two A1c goals, defined as reaching the goal for two consecutive follow-up visits. Costs of the diabetes drugs were estimated from Marketscan data. Costs by baseline A1c levels were estimated using a generalized linear model with Gamma distribution and log link. 3698 participants in the control arm achieved the goal of 7-7.9%, and 4135 in the intervention arm achieved the goal of &lt;7%. Estimated monthly cost increased by baseline A1c level and was higher for achieving A1c&lt;7% than 7-7.9% (Figure). In patients with a baseline A1c of 11%, the estimated cost was $610 per month ($7320 per year) for achieving &lt;7% and $413 per month ($4956 per year) for achieving 7-7.9%. In patients with a baseline A1c level of 9%, the corresponding estimates were $430 per month ($5160 per year) and $266 per month ($3192 per year). Our study provides critical cost estimates needed for assessing the cost-effectiveness of tighter glucose control in the U.S.

Disclosure
P. Zhang: None. H. Shao: None. A. Bertoni: None. L. Lovato: None. H. Chen: None.
116-LB: Evaluating the Impact of Glucommander on Improvement in Time-in-Range (TIR) in Type 2 Diabetes Using Continuous Glucose Monitoring
Authors: BODE BRUCE W. , CLARKE JOHN G. 
Published: June 2020

A proof of concept single center prospective study aimed at evaluating the safety and efficacy of utilizing Glucommander outpatient insulin dosing software to assist providers in titrating basal bolus insulin doses, using Abbott Freestyle Libre 14-day glucose monitoring system. A total of 25 adults (18-80), having T2D and an A1C &gt; 8%, were enrolled. A nurse educator provided patient education on insulin administration, meal planning and use of the glucose sensor. Baseline CGM data was collected during week 1, after which time participants insulin doses were titrated weekly for the next 4 weeks. Data was collected on initial HbA1C, days of CGM wear, time in range (TIR), and time in hypoglycemia. Use of Glucommander significantly improved TIR from a baseline of 48.02% during the initial week to 73.84% during the final week of treatment (p&lt;0.00001). Time in hypoglycemia (BG &lt; 54 mg/dl) decreased from 0.37% during the initial week to 0.33% during the final week of treatment (p&gt;0.557). % Changes in insulin: %Change(Basal) = 10.5%, %Change(Total Boluses)= 19.7%, %Change(TDD)= 15.1%.

Disclosure
B.W. Bode: Advisory Panel; Self; Medtronic, Novo Nordisk A/S. Consultant; Self; Eli Lilly and Company, Medtronic, Novo Nordisk A/S. Research Support; Self; Abbott, Advance, Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., MannKind Corporation, Medtronic, National Institutes of Health, Nova Biomedical, Novo Nordisk A/S, Provention Bio, Inc., Sanofi, Senseonics. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., MannKind Corporation, Medtronic, Novo Nordisk A/S, Sanofi, Senseonics. Stock/Shareholder; Self; Aseko. J.G. Clarke: Employee; Self; Glytec. Stock/Shareholder; Self; Glytec.

Funding
Glytec, LLC
1160-P: Impact of Reduced Medication Out-of-Pocket Costs on Acute Diabetes Complications and High-Acuity Outcomes: A Natural Experiment for Translation in Diabetes (NEXT-D2) Study
Authors: WHARAM J. FRANK , LAKOMA MATTHEW , ZHANG FANG , WALLACE JAMIE , GARABEDIAN LAURA F. , SOUMERAI STEPHEN B. , ROSS-DEGNAN DENNIS 
Published: June 2020

In an attempt to improve diabetes outcomes, some employers and insurers have adopted Preventive Drug Lists (PDLs) that reduce out-of-pocket costs for antidiabetic and cardioprotective medications to $0. We sought to determine whether shifts to PDL coverage reduce acute diabetes complications and high-acuity outcomes among commercially insured patients with diabetes. Our study design was a natural experiment comparing changes in outcomes 1 year before and after the PDL switch in matched study groups. The Intervention group included 16,174 commercially-insured diabetes patients age 12-64 switched by their employers to PDL coverage; the Control group included 711,085 coarsened exact-matched contemporaneous patients whose employers offered no PDL. We conducted similar analyses in a subset of low-income members switched to PDL plans and their matched controls. Outcomes were acute diabetes complication visits, high-severity emergency department visits, and hospitalization days. Transition to the PDL was associated with a relative pre-post change of 1.6% (95% confidence interval, -7.2% to 10.3%) in acute diabetes complication visits, -3.2% (-14.4% to 8.1%) in high-severity emergency department visits, and 2.2% (-9.8% to 14.1%) in hospitalization days. Findings were similar in the low-income subgroup. We did not find detectable changes in acute diabetes complication visits and high-acuity outcomes among diabetes patients switched to low drug cost sharing health plans. Further research should assess longer-term outcomes and examine effects of reducing financial barriers to outpatient and emergency department care.

Disclosure
J. Wharam: None. M. Lakoma: None. F. Zhang: None. J. Wallace: None. L.F. Garabedian: None. S.B. Soumerai: None. D. Ross-Degnan: None.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases; Centers for Disease Control and Prevention (5U18DP006122-05)
1161-P: Differences in U.S. Health Care Costs for Patients with Type 2 Diabetes: A Comparison Based upon HbA1c Thresholds
Authors: BOYE KRISTINA , LAGE MAUREEN J. , RAIBULET NEDINA K. , YU MARIA 
Published: June 2020

Objective: The ADA defines normoglycemia as HbA1c &lt; 5.7% and glycemic control for most adults with diabetes as HbA1c &lt; 7%. This research examined U.S. healthcare costs for patients with type 2 diabetes (T2D) with index HbA1c &lt; 5.7% (normoglycemia) compared to HbA1c ≥ 7% (above target).
Methods: The IBM® MarketScan® Commercial and Medicare databases (2013-2017) were used to identify adults with T2D, a recorded HbA1c result (first such date = index date), and continuous insurance coverage from 1 year prior through a 1 year post index date (post-period). Patients with normoglycemia were matched to patients with HbA1c above target without replacement. Using the propensity-score matched cohort, multivariable analyses examined the association between index HbA1c and healthcare costs.
Results: In the 1:1 matched cohort (7,567 normoglycemia; 7,567 above target), multivariable analyses showed that patients with normoglycemia had significantly lower post-period all-cause and diabetes-related drug costs, acute care costs, and outpatient costs compared to patients above target. Total diabetes-related costs were 25% lower (Figure 1) and all-cause total costs were 4% lower (both P&lt;0.0001) for patients with normoglycemia compared to those with index HbA1c above target.
Conclusion: Results suggest significant economic benefits associated with normoglycemia compared to HbA1c ≥ 7%.

Disclosure
K. Boye: Employee; Self; Lilly Diabetes. Stock/Shareholder; Self; Eli Lilly and Company. M.J. Lage: Consultant; Self; Eli Lilly and Company. Consultant; Spouse/Partner; Eli Lilly and Company. N.K. Raibulet: Employee; Self; Eli Lilly and Company. M. Yu: Employee; Self; Eli Lilly and Company. Employee; Spouse/Partner; LifeLabs. Stock/Shareholder; Self; Eli Lilly and Company.
1167-P: CSII and Insulin: Does Extending the Wear Duration of Infusion Sets Save Expensive Insulin?
Authors: CHATTARAJ SARNATH , FIENUP MARISA , ZHANG GINA , TIECK MARIE 
Published: June 2020

Objective: Patients using continuous subcutaneous insulin infusion (CSII) as a means of insulin delivery are advised to replace their infusion set every 2-3 days, as the probability of adverse events related to insertion increases after 72 hours, according to labeling and manufacturer’s instructions. When the infusion set is changed the remaining unused insulin in the reservoir and infusion set tubing are usually thrown away. The potential savings associated with extending the duration of infusion set wear from 2-3 days to 7 days was determined from the perspective of insulin pump users.
Method: The discarded insulin volume in the reservoir and infusion set under a current-wear scenario of 2-3 days versus 7 days was modeled. A mix of best-case (use for a 3-day set/reservoir with the shortest length of tubing) and worst-case (normal use for a 3-day set/reservoir with longest tubing) scenarios was used. Insulin cost savings were computed for the 3-day scenario assuming a complete infusion set and reservoir change every 3 days. Under the 7-day scenario, a complete infusion set change occurred every 7 days, while the reservoir was changed midway between complete changes. Under the best-case scenario, reservoirs were discarded by the end of 7 days.
Results: For the insulin pump users, the average annual reduction in discarded insulin volume was calculated to save about 5-10 vials of insulin per year per pump user. The corresponding cost reduction per user due to insulin savings was ∼$1,500 to $3,000 per year per pump user (based on ∼ $300/insulin vial; IBM Micromedex Red Book).
Conclusion: Using infusion sets that last for 7 days can yield substantial savings to patients, private health plans, and other payers (e.g., Centers for Medicare and Medicaid Services). Work is in progress to assess environmental impact cost savings due to reduction in material waste when extending the duration of infusion set wear from 2-3 days to 7 days.

Disclosure
S. Chattaraj: Employee; Self; Medtronic. M. Fienup: Employee; Self; Medtronic. G. Zhang: None. M. Tieck: None.
1168-P: Effectiveness of a Comprehensive Diabetes Program for Patients with Poorly Controlled Diabetes in an Academic Health Care System: The Emory Diabetes Management Program
Authors: GALINDO RODOLFO J. , PENG LIMIN , SMITH ZIRKA T. , JACOBS SOL , KHOSRAVANIPOUR MARJAN K. , TURTON FREDERICK E. , MASI CHRISTOPHER M. , ESPER GREGORY J. , WYLDE BJAY , CASTELLANO PENNY A. , UMPIERREZ GUILLERMO E. 
Published: June 2020

The Emory Diabetes Management Program (DMP) is a four-core chronic care management model including 1) specialized ambulatory program led by educators and advanced practitioners, 2) inpatient care protocols, 3) education of healthcare professionals through webinars, live sessions and “train-the-trainer” program, and 4) surveillance and data sharing/monitoring. The DMP goal is to reduce the percentage of patients within the Emory Healthcare System with A1c &gt;9% to &lt;15%. We report our results from 02/01/18 to 01/31/2019. Among 27,061 patients, the overall % of patients with A1c &gt;9% reduced from 20.5% to 17.2%, with improvement observed in all clinic operating units-- primary care (19.4 to 16.2%), family medicine (24.2% to 21.9%) and endocrinology (23.3 to 18.8%). Among 922 patients referred to the specialized ambulatory program (core 1), 644 participated (DMP) and 278 declined participation (No-DMP). DMP participants had greater improvement in A1c from baseline (-1.3%±2.5 vs. -0.5%±2.1, p&lt;0.01), and a reduction in % of patients with A1c &gt;9% by 26% (from 64% to 38%) vs. 12% (from 61% to 49%) compared to No-DMP group, p&lt;0.01. The Emory-DMP, is an effective population management program for improving diabetes care, with significant reduction in the number of patients with poor control diabetes.

Disclosure
R.J. Galindo: Advisory Panel; Self; Lilly Diabetes. Consultant; Self; Valeritas, Inc. Research Support; Self; Novo Nordisk Inc. Other Relationship; Self; UpToDate. L. Peng: None. Z.T. Smith: None. S. Jacobs: None. M.K. Khosravanipour: None. F.E. Turton: None. C.M. Masi: None. G.J. Esper: None. B. Wylde: None. P.A. Castellano: Advisory Panel; Self; American Association of Medical Colleges. Board Member; Self; Vizient Inc. G.E. Umpierrez: None.
117-LB: Nonviral Direct Reprogramming of Human Skin Fibroblasts into Hormone-Expressing ß-Like Cell Clusters
Authors: LEMMERMAN LUKE R. , RINCON-BENAVIDES MARIA ANGELICA , TERSEY SARAH A. , BLACKSTONE BRITANI N. , POWELL HEATHER M. , HIGUITA-CASTRO NATALIA , MIRMIRA RAGHAVENDRA , GALLEGO-PEREZ DANIEL 
Published: June 2020

While allogenic islet grafting has shown significant promise for the treatment of T1D, donor tissue scarcity and the need for aggressive immunosuppression has limited widespread use of this therapy. Consequently, recent studies have focused on deriving β-like cells from autologoussources (e.g., exocrine pancreas, iPSCs) via reprogramming and/or lengthy differentiation protocols. However, current approaches to β-cell derivation face several hurdles, including limited and/or functionally impaired cell sources, tedious pre-processing steps, and heavy reliance on viral vectors (i.e., for cell transformations), among others. Here we report on the development ofa non-viral approach to β-cell derivation from human skin fibroblasts via direct reprogramming.Human fibroblasts were isolated from surgical discard tissue. Electroporation was then used to screen a pool of transcription factor genes that included Pdx1, Ngn3, MafA, Pax4, and Tcf3, to identify optimum permutations that can drive β-cell-directed conversions in human skin fibroblast cultures. Transfection extent, efficiencies, and transcriptive activity, were evaluated by qRT-PCR,fluorescence microscopy, and RNA sequencing. Transfected fibroblasts were maintained indifferentiation media for ~3 weeks. β-cell-directed transformations were evaluated in terms of morphology and C-peptide expression. Our results indicate that while transfection with Tcf3 alone did not lead to significant changes in cell morphology and phenotype compared to sham, co-transfection of Tcf3 with Pdx1+Ngn3+MafA (PNM) or Pdx1+Ngn3+MafA+Pax4 (PNMP) led to cell clustering, as well as C-peptide expression as early as day 15 post-transfection, which was absent in fibroblasts transfected only with PNM or PNMP. Altogether, our findings indicate that Tcf3 maybe a key factor in enabling direct conversion of human dermal fibroblasts into hormone-expressingβ-like cells for potential applications in β-cell replacement therapies.

Disclosure
L.R. Lemmerman: None. M. Rincon-Benavides: None. S.A. Tersey: None. B.N. Blackstone: None. H.M. Powell: None. N. Higuita-Castro: None. R. Mirmira: Advisory Panel; Self; Hibercell, Sigilon Therapeutics, Veralox Therapeutics. Employee; Spouse/Partner; Eli Lilly and Company. D. Gallego-Perez: None.
1172-P: Impact of Telemedicine Clinics in the Management of Type 1 Diabetes
Authors: EILAND LESLIE A. , SIAHPUSH MOHAMMAD , AKKIREDDY PADMAJA , KUECHENMEISTER LISA 
Published: June 2020

Background: Our institution began telemedicine clinics at rural hospitals in 2013, with standard office visits delivered synchronously via video conferencing. This project aims to assess the impact of telemedicine clinics in T1D care at our institution.
Methods: IRB approval was obtained to access records of people with T1D with three or more telemedicine visits from Nov 2013 to Oct 2019. To assess change in A1c, we used a random coefficient regression model and estimated the effect of time on A1c, controlling for gender and age at start of treatment. Data were collected on change in treatment and prior provider (PCP, outside/academic endocrinologist).
Results: The 139 patients evaluated (average age 45 y (range 16-94), 58% F) had an average of 8 A1c values (2-23) over an average duration of 32 mos (4-69). The scatterplot and fitted regression line show a temporal A1c decline. Similarly, random coefficient regression analysis provided overwhelming evidence for an A1c decline (P&lt; 0.001). Each year in telemedicine care was associated with a decline of 0.13 in A1c (95% CI: -0.20, -0.06). Age and gender were not associated with A1c. A1c decline was noted irrespective of prior provider or treatment change (ie, starting CGM/pump therapy).
Conclusions: Our data supports the concept that T1D can be effectively managed via telemedicine. Declines in A1c were seen in all groups, irrespective of age, prior provider and additions of diabetes technology.

Disclosure
L.A. Eiland: None. M. Siahpush: None. P. Akkireddy: None. L. Kuechenmeister: None.