bluuebunny/crossref_metadata_2025 huggingface dataset:
2154-PUB: Determination of Non-HDL Cholesterol in Type 1 Diabetic Patients
Authors: FERNANDES VIRGINIA O. , PEREIRA RAISSA B.O. , SALES MAYARA T.A. , SOUSA MILENA S. , ARAGÃO LUCIANA F.F. , CARVALHO ANNELISE B. , LINHARES NANCY , CASTELO MARIA HELANE , MONTENEGRO RENAN M. , MONTENEGRO ANA PAULA D.
Published: June 2020

Aim: To describe non-HDL cholesterol levels (non-HDL-c) and the factors that might interfere with these levels in children with type 1 diabetes (T1D), determining their cost-effectiveness compared to LDL-cholesterol (LDL-c) in clinical practice and the laboratory cut-off point suggestion for intervention.

Method: Cross-sectional descriptive study with analysis of cholesterol levels, especially non-HDL-c, in children (under 19 years old) with T1D and in a control group (children under 19 years without diabetes).Were evaluated 144 T1D and 138 controls. The variables were anthropometric data, pubertal staging, glycated hemoglobin (A1c) and lipid profile. Patients with disease or on medications that could cause dyslipidemia were exclude from this study. The variables were analyze using RedCap and Jamovi.

Results: A total of 282 children participated in this study. The non-HDL-c was 122.64 ± 37.67 and in the control was 108.70 ± 28.10, with no significant difference between them. Non-HDL-c was significantly correlated with A1c (p= 0,001), but did not correlate with gender, BMI, disease duration and pubertal stage. There was observed that LDL-c and had a strong correlation with each other R = 0.929. According to LDL-c abnormality values proposed for children (where values between 100 and 130 mg/dl, should initiate lifestyle change and above 130 mg/dl, drug therapy) the ROC curve presented a cutoff value of non-HDL-c of 125mg ∕ dl and 147mg ∕ dl.

Conclusion: In this population, glycemic control seems to interfere with the lipid profile, which wasn’t observed with BMI and index and pubertal stage. This study also suggest a lower cut-off point of non-HDL-c for therapeutic intervention.

Disclosure

V.O. Fernandes: None. R.B.O. Pereira: None. M.T.A. Sales: None. M.S. Sousa: None. L.F.F. Aragão: None. A.B. Carvalho: None. N. Linhares: None. M. Castelo: None. R.M. Montenegro: None. A.D. Montenegro: None.
2160-PUB: Development of an Evidence-Based Tool to Facilitate Individualized Treatment in the Clinic for Patients with Type 2 Diabetes
Authors: KAHKOSKA ANNA R. , BUSE JOHN B. , HARRING SIGNE , HOLST INGRID , KNOP FILIP K. , KVIST KAJSA , PRATLEY RICHARD E.
Published: June 2020

Type 2 diabetes (T2D) is a heterogeneous disease with many therapies available. Current guidelines recommend individualized therapy, and this could be facilitated by using estimates of outcomes based on individual characteristics instead of population-level outcomes. There are challenges to defining and implementing individualized therapy in a data-driven and patient-oriented way. We propose criteria to aid implementation of individualized medicine, including: 1) robust insights based on high-quality clinical data, to guide treatment selection; 2) integration of patient-oriented outcomes with engagement of providers and patients; 3) provision of a user-friendly, efficient tool for use in the clinic. We are developing an interactive tool that draws on data from a wide range of randomized controlled trials, e.g., all treatment arms from the full phase 3a program for once-weekly semaglutide. The tool selects the appropriate trial from a database and shows the predicted change in outcomes on initiation/continuation with different therapies over 26-30 weeks. Estimates are based on characteristics such as age, BMI, and T2D duration (Figure).

In conclusion, a tool such as this could help clinicians and patients use high-quality, large-scale data from contemporary trials to select individualized treatment regimens.

Disclosure

A.R. Kahkoska: Other Relationship; Self; Novo Nordisk A/S. J.B. Buse: Consultant; Self; Cirius Therapeutics, CSL Behring, Neurimmune. Research Support; Self; American Diabetes Association, National Institutes of Health, Novo Nordisk A/S, Patient-Centered Outcomes Research Institute, Sanofi, Tolerion, Inc., vTv Therapeutics. Stock/Shareholder; Self; Mellitus Health, Pendulum Therapeutics, PhaseBio Pharmaceuticals, Inc., Stability Health. Other Relationship; Self; ADOCIA, AstraZeneca, Dance Biopharm Holdings, Inc., Eli Lilly and Company, MannKind Corporation, NovaTarg Therapeutics, Novo Nordisk A/S, Senseonics, Inc, vTv Therapeutics, Zafgen, Inc. S. Harring: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. I. Holst: Employee; Self; Novo Nordisk A/S. F.K. Knop: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk A/S, Sanofi. Consultant; Self; Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Gubra, Novo Nordisk A/S, Sanofi, Zealand Pharma A/S. Speaker’s Bureau; Self; AstraZeneca, Lupin Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Norgine B.V., Novo Nordisk A/S. K. Kvist: Employee; Self; Novo Nordisk A/S. R.E. Pratley: Other Relationship; Self; AstraZeneca, Eli Lilly and Company, GlaxoSmithKline plc., Glytec, Janssen Scientific Affairs, LLC., Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals Incorporated, Merck & Co., Inc., Novo Nordisk Inc., Sanofi.

Funding

Novo Nordisk A/S
2166-PUB: Surprisingly High Prevalence of Vitamin D Deficiency in Japanese Diabetic Patients
Authors: KASHIMA NAOYASU , HAMANO KUMIKO
Published: June 2020

Vitamin D is known to regulate many cellular functions such as insulin secretion, cardiac function, immune system, skeletal muscle in addition to bone mineral metabolism. With respect to diabetes, diabetes prevention trials by vitamin D supplementation and reports showing an association between low levels of blood vitamin D and cardiovascular events, bone fractures, falls and most recently the life prognosis have been published. However, reports on Japanese diabetic patients and vitamin D is scarce. We measured serum 25 (OH) D concentration (ECLIA) in 133 patients (M/F: 85/48) with type 1 (n=15) and type 2 diabetes patients (118). Age, sex, BMI and biochemical indicators (serum Ca, P, Alb, HbA1c, LDL-C, TG, CPR and atherosclerosis indices (urinary albumin, NT-proBNP, baPWV and max IMT) were investigated. The subjects mean age was 59.1±14.0 years (mean±SD) and HbA1c9.1 ±2.6%, and BMI25.0±4.3. Serum 25 (OH) D concentration state was only 3% in sufficient group(>30ng/ml), 11% insufficient group and 86% was in deficiency (<20ng/ml). This was the same regardless of type 1 or type 2. Correlations with the aforementioned indicators including HbA1c was not observed. However, serum 25 (OH) D concentration and max IMT in HbA1c above 8% group had a weak but significant reverse correlation, which was consistent with the previous metaanalysis. The limitation of this study is a single center based, and it does not include data on dieting status, or exposure to sunlight. However, subjects have a history of medical nutritional education and they are residents of urban areas with adequate ADL, it is unlikely that they are particularly biased diabetes populations. In an aging society, it is important to prevent sarcopenia, and fractures in diabetes. The present results shed a new insight in Japanese medical nutritional therapy. For vitamin D deficiency cohort, interventions and bone salt quantification are going to be carried out and osteoporosis, fractures, and cardiovascular risk are evaluated in a prospective manner.

Disclosure

N. Kashima: None. K. Hamano: None.
2177-PUB: Improved Time-in-Range and Glycemic Variability in Adults with Type 1 Diabetes: An Analysis of 12-Week Flash Glucose Monitoring Data from a Multicenter Prospective Trial
Authors: GUO LIXIN , ZHANG MEI , KUANG HONGYU , LI YUXIU , XIAO XINHUA , JIA XIAOFAN , YANG TAO
Published: June 2020

Aims: Studies have demonstrated that CGM can improve HbA1C and reduce glucose variability in individuals with type 1 diabetes (T1D). We aim to assess the efficacy of flash glucose technology on glycemic accuracy control in T1D by lifestyle and/or medication modification and to use the CGM time in range (TIR) as outcomes of measures.

Methods: The program is a multicenter, prospective, RCT enrolled adults from 5 Chinese diabetes centers. Individuals were eligible to participate if they had T1D and were deemed technically capable of using flash glucose technology. All participants had no experience with Flash before participating the study and received the education of diabetes self-care at baseline. Based on the glucose reports, dietary, excise and insulin therapy changes were made by self-care behaviors. Data from 153 adults who using flash glucose monitoring for 12 weeks were analyzed.

Results: After 153 participants who had no experience with flash used flash for 12 weeks, HbA1C was reduced from (7.96± 1.78) % at baseline to (7.54±1.20) % at 12 weeks (P<0.05). An increase in TIR70-180 was from 51.49% to 54.68%. The TAR >250 drop from 12.65% to 7.77%, with a concurrent decrease in TBR54-69 from 9.96% to 8.31% and TBR<54 from 4.21% to 3.19%(P<0.005). And the CV reduced from 39.5% to 37.3% in these patients(P<0.05).

Conclusion: T1D patients who had no experience with flash achieved a better glycemic profile from the flash glucose monitoring. Flash glucose technology is useful for improving glycemic control of T1D patients by changes to patient’s lifestyle and/or insulin therapy.

Disclosure

L. Guo: None. M. Zhang: None. H. Kuang: None. Y. Li: None. X. Xiao: None. X. Jia: None. T. Yang: None.
2179-PUB: Trends in the Use of Diabetes Technologies in Germany
Authors: HEINEMANN LUTZ , HERMANNS NORBERT , EHRMANN DOMINIC , KULZER BERNHARD
Published: June 2020

Since 2018, an annual survey is conducted to assess the use of diabetes technology in Germany. In this year’s evaluation of current use of diabetes technology, 326 diabetologists participated in the online survey. On average, the participating diabetologists reported that they had 189 people with type 1 diabetes and 850 people with type 2 diabetes in their clinical unit. We compared the use of insulin pumps (CSII), Flash Sensor-based Glucose Monitoring use (FSGM) and real-time Continuous Glucose Monitoring (rtCGM) in 2018 and 2019. In type 1 diabetes, the number of insulin pump users rose from 56 to 75 persons per clinical unit representing an increase of 34%, the number of FSGM users increased by 38% from 81 to 112 persons per clinical unit, and the number of rtCGM users rose by 76% from 33 to 58 persons per clinical unit. Per clinical unit, three users with a commercially available closed loop system and on average one user with a self-constructed closed loop system were reported. In the year 2019 the diabetologist reported that 22.3% of all persons type 1 diabetes used rtCGM; 44.2% used FSGM and 27.9% were CSII users. Overall 67% of type 1 diabetes used one of these key diabetes technologies. In type 2 diabetes, FSGM was the most common used diabetes technology. Its use increased by 38% from 81 to 112 persons per clinical unit; insulin pumps were rather rarely used with only 4 and 3 users per unit in 2018 and 2019, respectively. rtCGM was only used by 10 persons per clinical unit in 2019, representing an increase of 25% compared to 2018. In type 2 diabetes the overall the use of diabetes technology was much smaller than in type 1 diabetes; 1% were rtCGM users, 12% used FSGM and only 0.3% used CSII. The use of diabetes technology is clearly more prominent in type 1 diabetes, in which 2 out of 3 persons are using at least one of the key diabetes technologies. There is also a clear trend of an increased use of diabetes technology in type 1 and type 2 diabetes in Germany.

Disclosure

L. Heinemann: Consultant; Self; Becton, Dickinson and Company, LifeCare, Inc., Roche Diabetes Care. Stock/Shareholder; Self; Profil Institute for Clinical Research. N. Hermanns: Advisory Panel; Self; Roche Diabetes Care. Research Support; Self; Abbott, AstraZeneca, Berlin-Chemie AG. D. Ehrmann: Speaker’s Bureau; Self; Abbott, Berlin-Chemie AG, Glooko, Inc. Other Relationship; Self; Dexcom, Inc., Roche Diabetes Care. B. Kulzer: Research Support; Self; Abbott, AstraZeneca, Berlin-Chemie AG, Roche Diabetes Care. Speaker’s Bureau; Self; Abbott, Ascensia Diabetes Care, Berlin-Chemie AG, Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Roche Diabetes Care.

Funding

Berlin-Chemie AG
2180-PUB: Integration of Continuous Glucose Monitoring in Diabetes Self-Management Education for Type 2 Diabetes Improves Glycemic Control
Authors: FORTMANN ADDIE L. , BASTIAN ALESSANDRA , LENSING CODY J. , HOVERSTEN SHANE , LUU KIMBERLY , BARGER KELLY , TALAVERA LAURA , PHILIS-TSIMIKAS ATHENA
Published: June 2020

Continuous glucose monitors (CGM) are an integral aspect in the glucose management of many individuals with type 1 diabetes, and a growing number of people with insulin-requiring type 2 diabetes (T2D). A 2019 meta-analysis of 7 randomized controlled trials that investigated CGMs for T2D reported that CGM users had significantly lower HbA1c and shorter time spent with hypoglycemia compared with self-monitoring blood glucose comparison groups. However, little is known about optimal, real world approaches for integrating CGM in the routine management of patients with T2D. A pragmatic, feasibility pilot (n=6) was conducted to document the preliminary effectiveness and acceptability of introducing CGM in the context of a 5-class diabetes self-management education (DSME) series at Scripps Health, a large, non-profit, private insurance-based health system in San Diego, CA. Prior to class 2, English- (n = 3) and Spanish-speaking (n = 3) adults with T2D self-inserted the CGM and received enough sensors to wear the CGM until 6 weeks post-DSME (10 weeks total). During classes 3-5, time was devoted to reviewing the past week’s CGM data report and participants were encouraged to make associations between glucose trends and eating and exercise patterns. CGM wear ranged from 5 to 10 weeks (M =7.8 ± 1.7 weeks). Time-in-range (70-180 mg/dL) and mean average glucose improved from 54% and 185.1 ± 67.9 mg/dL at baseline to 74% and 159.1 ± 50.5 mg/dL by the end of DSME, and to 84% and 142.7 ± 30.6 mg/dL at 4-weeks post-DSME. Self-report surveys indicated improvements in healthful eating and physical activity over this time, and participants reported very high satisfaction with the CGM; the majority expressed a desire to continue CGM use post-study. Findings highlight DSME as a promising environment for effectively integrating CGM in the management of T2D. Future research should pinpoint the duration and frequency of CGM use for optimal clinical benefit in the general T2D population.

Disclosure

A.L. Fortmann: None. A. Bastian: None. C.J. Lensing: Employee; Self; UnitedHealth Group. Employee; Spouse/Partner; UnitedHealth Group. S. Hoversten: Employee; Self; UnitedHealth Group. K. Luu: None. K. Barger: None. L. Talavera: None. A. Philis-Tsimikas: Advisory Panel; Self; Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi.

Funding

UnitedHealth Group; Dexcom, Inc.
2187-PUB: Identifying Risk Predictors for Gastrointestinal Adverse Events with Once-Weekly Semaglutide
Authors: VILSBØLL TINA , HARRING SIGNE , HOLST INGRID , KNOP FILIP K. , KVIST KAJSA , LINGVAY ILDIKO
Published: June 2020

Gastrointestinal adverse events (GI AEs) are common with glucagon-like peptide-1 receptor agonists (GLP-1RAs). We aimed to identify risk predictors for GI AEs with once-weekly semaglutide to support clinicians identify high-risk patients. Data from SUSTAIN 1-10 and two SUSTAIN Japanese trials were used to assess the effects of age, region, ethnicity, diabetes duration, gender, renal function, smoking status, HbA1c, body weight (BW), alanine aminotransferase and bilirubin on the incidence of GI AEs with semaglutide vs. non-GLP-1RA comparators (exenatide extended release, dulaglutide and liraglutide were excluded). Changes in HbA1c and BW were assessed by GI AE status. Frailty (age, renal impairment, smoking) and female gender were associated with marginally higher risk of GI AEs than non-frailty and male gender, regardless of treatment. With semaglutide, patients with lower baseline BW were at higher risk of GI AEs vs. those with higher BW. With comparators, lower baseline BW was associated with lower risk than higher BW. These results were confirmed by formal statistical analysis (data not shown). Semaglutide reduced HbA1c and BW across the trials, regardless of GI AEs (Figure). In conclusion, GI AEs are hard to predict although they tend to be more common in frail vs. non-frail patients and females vs. males, regardless of treatment. Semaglutide reduced HbA1c and BW regardless of the presence/absence of GI AEs.

Disclosure

T. Vilsbøll: Advisory Panel; Self; AstraZeneca, Mundipharma International, Novo Nordisk A/S, Sun Pharmaceutical Industries Ltd. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes, Medscape, Merck Sharp & Dohme Corp., Sanofi. S. Harring: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. I. Holst: Employee; Self; Novo Nordisk A/S. F.K. Knop: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk A/S, Sanofi. Consultant; Self; Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Gubra, Novo Nordisk A/S, Sanofi, Zealand Pharma A/S. Speaker’s Bureau; Self; AstraZeneca, Lupin Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Norgine B.V., Novo Nordisk A/S. K. Kvist: Employee; Self; Novo Nordisk A/S. I. Lingvay: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., MannKind Corporation, Novo Nordisk A/S, Sanofi, TARGET PharmaSolutions, Valeritas, Inc. Other Relationship; Self; Novo Nordisk A/S.

Funding

Novo Nordisk A/S
2205-PUB: New Strategy for Treating Diabetes with Traditional Chinese Medicine
Authors: HUA XIANGRONG , HUANG AMY Y.
Published: June 2020

Introduction: Diabetes is a group of metabolic disorders characterized by high blood glucose in patients. In spite of numerous progresses have been achieved in diabetes research and care, it is still challenging to cure diabetes. The objective of this study was to explore a new approach to treat diabetes with Traditional Chinese Medicine.

Materials and Method: The Traditional Chinese Medicine used in this study was a natural bio-product(s) (NBP) which has been used for humans for several hundred years. This NBP was dried and grinded into powders and capsulated (patent pending). Based on the degree of severity determined by OGTT data analysis, patients took 4.5g - 30g of this NBP orally per day for 3 to 24 months, and might take prescribed medicines (Gliclazide MR, Metformin, and/or Saxagliptin) at the initial stage of therapy. Starting on the first day of therapy, the patients discontinued the insulin injection if they had relied on it.

Results: The patients ranged from 34 yo to 73 yo (mean=55.6 yo, n=18). Before therapy, six of 18 patients were on a regular insulin injection with various dosages, and the mean HbA1c was 7.65 (SD=1.97, n=18). After therapy (without any insulin injection) for an average of 231 days (97-748 days), the mean HbA1c was 6.61 (SD=0.86, n=18). The difference was statistically different (t-test, p=0.008). Ten of 18 patients were on western medicines for an average of 77 days while the rest took NBP only. The insulin resistance (estimated by HOMA-IR) decreased and the disposition index (estimated at 2-h OGTT) increased in 12 of the 18 patients.

Discussion and Conclusion: This NBP can effectively control plasma glucose level by reducing the insulin resistance and enhancing the beta cell functions. However, its exact mechanism is not clear, partially because this NBP is a compound which may affect multiple systems simultaneously. This method might not be suitable for all patients with T2DM. Further studies are needed in order to fully understand its mechanisms for controlling plasma glucose level.

Disclosure

X. Hua: Board Member; Self; CYX Biotechnology Ltd. A.Y. Huang: Research Support; Self; CYX Biotechnology Co.
2211-PUB: Safety and Efficacy of Hydroxychloroquine (HCQ) in Management of Patients with T2D
Authors: CHAWLA MANOJ S. , CHAWLA PURVI M. , SAYYED ALFALAK , SHAH AMI , MURTHY NANDITA
Published: June 2020

Chronic inflammation is implicated in the pathophysiology of type 2 diabetes (T2D), and therefore targeting inflammation may ameliorate diabetes, slowing its progression and complications. HCQ, an anti-inflammatory agent used since several decades in rheumatology, is approved in India for the management of T2D. We assessed the real-life safety and effectiveness of HCQ in 95 T2D patients uncontrolled on 2 or more OHAs with or without insulin. HCQ was started only in patients with normal retina on fundoscopy, which was repeated again within 52 weeks. Mean duration of diabetes was 9.09 years; 51 and 38 patients were receiving statins and anti-hypertensives, respectively at baseline. There was a reduction in A1c and other glycemic parameters at Week 12 and week 24 from baseline. Total cholesterol and LDL also reduced with HCQ use. Mean body weight reduced from 73.59 kg at baseline to 72.84 kg at Week 24. Reassuringly, there were no cases of HCQ-induced retinopathy in any of the patients followed till week 52; 1 patient was detected with mild NPDR at week 12 and drug was discontinued. Of the 12 AEs reported, 11 were mild in intensity and unlikely related to HCQ. There was no incidence of derangement in hepatic or renal parameters. Thus, HCQ could be a well-tolerated and effective therapeutic option for patients with T2D uncontrolled on 2 or more OHAs. Long term data for safety and efficacy of HCQ needs to be studied from other centers too.

Disclosure

M.S. Chawla: Speaker’s Bureau; Self; Abbott, Alkem Laboratories, AstraZeneca, Biocon. Speaker’s Bureau; Spouse/Partner; Boehringer Ingelheim Pharmaceuticals, Inc. Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Glenmark Pharmaceuticals Limited, Lupin Pharmaceuticals, Inc., Novartis AG, Novo Nordisk A/S. Speaker’s Bureau; Spouse/Partner; Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; Sanofi, Serdia Pharmaceuticals (India) Pvt. Ltd. P.M. Chawla: Speaker’s Bureau; Spouse/Partner; Abbott, Alkem Laboratories, Boehringer Ingelheim Pharmaceuticals, Inc. Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Speaker’s Bureau; Spouse/Partner; Eli Lilly and Company, Lupin Pharmaceuticals, Inc. Speaker’s Bureau; Self; Novo Nordisk A/S. Speaker’s Bureau; Spouse/Partner; Novo Nordisk A/S. Speaker’s Bureau; Self; Sanofi. Speaker’s Bureau; Spouse/Partner; Sanofi. A. Sayyed: None. A. Shah: None. N. Murthy: None.
2215-PUB: Impact of Continuous Positive Airway Pressure Compliance on Complications in Patients with Type 2 Diabetes and Obstructive Sleep Apnea
Authors: REUTRAKUL SIRIMON , PRASAD BHARATI , SAHNI ASHIMA , MATANI SARA , SHETH URMI , DANIELSON KIRSTIE K. , MONSON REBECCA S. , CARLUCCI MELISSA , MERCADO TOMAS , SMITH MAUREEN
Published: June 2020

Continuous positive airway pressure (CPAP) treatment has been shown to be beneficial to patients with obstructive sleep apnea (OSA) by reducing blood pressure and possibly slowing progression of chronic kidney disease. However, there is a dearth of research on the effects of CPAP treatment, especially compliance, on these outcomes in patients with type 2 diabetes (T2D) in a real world setting.

Methods: A single-center, retrospective chart review was conducted on patients with T2D who were diagnosed with OSA between 2010 and 2018. The first available CPAP report following the polysomnography was used to determine compliance (CPAP usage for >4 h/night for >70% of nights). Data such as estimated glomerular filtration rate (eGFR), A1C, blood pressure, lipid panel, and incident cardiovascular/peripheral vascular/cerebrovascular events (CVD, PVD and CVA) were extracted from the charts. Mixed-effects linear regression modeling of longitudinal repeated measures within patients was utilized for continuous outcomes, and logistic regression modeling was used for incident events. All models were controlled for age, sex, body mass index (BMI), medications, and baseline levels of outcomes.

Results: Of the 1,295 patients, 239 (18.4%) were compliant and 339 (26.2%) were non-compliant with CPAP, while 717 (55.3%) had insufficient data. Compared to those who were CPAP non-compliant, those who were compliant had a significantly lower systolic blood pressure (β=-2.28 mmHg, p=0.0002), lower diastolic blood pressure (β=-2.52 mmHg, p<0.0001), and higher HDL (β=3.81 mg/dL, p=0.03). There were no significant differences between the two groups in eGFR, total cholesterol, LDL, triglycerides, A1C, incident CVD, PVD or CVA.

Conclusion: T2D patients with OSA who were compliant with CPAP had significantly lower blood pressure as well as higher HDL. However, eGFR, A1C, or cardiovascular events did not significantly differ by CPAP compliance in this study.

Disclosure

S. Reutrakul: None. B. Prasad: None. A. Sahni: None. S. Matani: None. U. Sheth: None. K.K. Danielson: None. M. Carlucci: None. T. Mercado: None. M. Smith: None.
2217-PUB: Remogliflozin in Indian T2DM Patients: A Real-World Study
Authors: BHATTACHARYA SUPRATIK , KATARE SAGAR
Published: June 2020

Introduction: Remogliflozin is new SGLT2i approved in India. It is prudent to evaluate its effectiveness and tolerability in real world setting.

Methods: In this observational study, retrospective data from EMR of tertiary care hospital in Kolkata, India was retrieved. The records of patients who were uncontrolled (HbA1c>7.5) on dual therapy (Metformin + DPP-4 inhibitors/Sulphonylureas) and subsequently treated with Remogliflozin for period of at least 6 months were selected. The records with evidence of active UTI at baseline, receiving injectable antidiabetic drugs or recorded eGFR <45 mL/min were excluded. The effectiveness was assessed in terms of change in HbA1c, FBS, PPBS, body weight after 3 and 6 months of treatment. The safety was assessed by adverse events recorded in medical records in terms of abnormal symptoms, signs or laboratory reported values. The data was analysed using appropriate statistical techniques.

Results: Medical records of 120 adult patients (56.7% male) with T2DM was selected. The mean baseline characteristics of the patients in terms of Age, HbA1c levels, FBS, PPBS, weight and BMI was 58±13 years, 8.2±0.6%, 132.8±12.4 mg/dL, 204±28.2 mg/dL, 71.8±5.4 kg and 28.2±2.6 kg/m2 respectively At end of 6 months of add on Remogliflozin treatment , the mean change from baseline in HbA1c, FBS, PPBS, Body weight and BMI was -1.3±0.4%, -17.2±9.2 mg/dL, -56.4±18.4 mg/dL, -4.2±1.8 kg, -1.8±0.6 kg/m2 (P<0.05 for all parameters). The reduction in body weight was more in patients on SUs as compared to DPP-4 inhibitors (-5.2 vs. -2.9kg). At end of 6 months, HbA1c reduced <8% in all patients while 66% achieved target HbA1c of 7%. No events of hypoglycaemia or electrolyte disturbances were reported. Combined incidence of UTI and GTI was 5.8% which were mild. In none of the patients Remogliflozin was discontinued for adverse events.

Conclusion: In real world clinical practice, add on therapy of Remogliflozin to existing OHA regimen is observed to be an effective, safe and tolerable option in management of Indian patients with type 2 diabetes mellitus.

Disclosure

S. Bhattacharya: None. S. Katare: Employee; Self; Glenmark Pharmaceuticals Limited.
2218-PUB: Initiation of SGLT2 Inhibitors in Hospitalized Patients with CVD
Authors: PALERMO NADINE E. , GOODBERLET MELANIE , CROMWELL GRACE , SMITH COLLEEN M. , CHANG LEE-SHING , BILODEAU AMY , PLUTZKY JORGE , SZUMITA PAUL M. , HULME OLIVIA , CANNON CHRISTOPHER , MCDONNELL MARIE E.
Published: June 2020

Recent data have shown significant benefit from SGLT2 inhibitors (SGLT2i) in patients with diabetes (DM) and cardiovascular disease (CVD) but experience with use in the acute care setting is limited and feasibility of initiating in the hospital is unclear. A multidisciplinary team of cardiology, endocrinology, and pharmacy developed a pilot to assess the feasibility of initiating SGLT2i in the hospital and subsequent transition of care. From 5/4/19 to 10/6/19, patients with DM on the cardiology service were identified and initiated on therapy with an SGLT2i if there were no contraindications. All patients were offered education via fact sheet, video, and/or focused consultation from the inpatient diabetes team. All prescriptions were either filled or verified as covered by insurance prior to discharge. An electronic communication was sent to notify the PCP and recommend basic metabolic labs be done at 2 weeks after initiation. 24 patients were eligible and 23 (96%) filled the prescription at discharge. 54.2% had CAD while 75% had CHF: 45.8% HFrEF and 29.2% HFpEF. The median GFR was 54 mL/min (44-64) and mean A1c was 8.1%. At 1 month, 71% remained on SGLT2i (n=17) and 63% completed recommended labs (n=15). 79% had outpatient follow up by 30 days (N=24) and 91% by 90 days (N=12). One patient died of respiratory failure within 30 days. 33% were readmitted within 90 days due to non-CHF cardiac illness (50%), respiratory problem (25%), lightheadedness (13%, n=1), or urinary tract infection (13%, n=1), and none for diabetes or CHF. There were no cases of metabolic acidosis or electrolyte disturbance. There was both a significant decrease in estimated GFR at 1 month (-6.95 mL/min, p= <0.01) and in systolic blood pressure of -4.62 mmHg (p=0.04). 6 patients had >30% reduced GFR and 1 advanced from CKD stage 4 to 5.

In conclusion, initiation of SGLT2i therapy in select patients with CVD and DM in the acute care setting appears to be feasible. Guidance is needed to ensure appropriate patient selection and medication adjustment in these patients.

Disclosure

N.E. Palermo: None. M. Goodberlet: None. G. Cromwell: None. C.M. Smith: None. L. Chang: Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc. Other Relationship; Self; Applied Therapeutics, Fractyl Laboratories, Inc., Novo Nordisk Inc., Sanofi. A. Bilodeau: None. J. Plutzky: Consultant; Self; Amgen, AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk A/S. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc. P.M. Szumita: None. O. Hulme: None. C. Cannon: None. M.E. McDonnell: None.
222-OR: A Call for a New Limb Salvage Paradigm for Patients with Diabetes
Authors: ZOLPER ELIZABETH G. , FAN KENNETH L. , MESHKIN DEAN , BEKENY JENNA C. , HILL CHRISTINE , MISHU MARK D. , CONNOLLY PATRICK , EVANS KAREN , ATTINGER CHRISTOPHER
Published: June 2020

Five-year mortality rates for patients with diabetes who undergo lower extremity amputation (LEA) have long been regarded as high and inevitable. Accepted five-year mortality rates exceed 50%. The aim of this study was to assess 5-year mortality after LEA performed with a multidisciplinary approach focused on function. We retrospectively enrolled all patients (n=312) with diabetes who underwent primary non-traumatic LEA at our institution from 2010-2013. Patients were stratified by LEA type: minor (toe, ray, TMA, Lisfranc, Chopart, Symes) or major (BKA, AKA). Surgical technique optimized biomechanics via tendon rebalancing with repurposing plantar skin for anterior coverage for minor LEA and myodesis of residual muscles with posterior myocutaneous flap closure for major LEA. Our multidisciplinary team, consisting of wound care, reconstructive, podiatric, vascular, and prosthetic specialists, ensures recovery and post-LEA function. Mortality was established via medical records and a commercial database then analyzed with Kaplan-Meier estimates. Five-year mortality was 31% (Figure); Charlson Comorbidity Index was 5.5±2.2. Five-year mortality was not significantly different for minor versus major LEA.

In conclusion, we have demonstrated improved 5-year mortality after LEA with multidisciplinary care focused on functional outcomes. Successful “limb salvage” is evaluated by preservation of function instead of limb length.

Disclosure

E.G. Zolper: None. K.L. Fan: None. D. Meshkin: None. J.C. Bekeny: None. C. Hill: None. M.D. Mishu: None. P. Connolly: None. K. Evans: None. C. Attinger: Consultant; Self; Acelity, Integra LifeSciences.

Funding

MedStar Diabetes
2227-PUB: The Experience of Spanish Speakers in the Real Health Study
Authors: CROMER SARA , RODRIGUEZ ANTHONY R. , BISSETT LAURIE , DUSHKIN AMY , GOLDMAN VALERIE M. , MCCARTHY JEANNA , DELAHANTY LINDA M. , WEXLER DEBORAH J.
Published: June 2020

The REAL HEALTH Diabetes study was a pragmatic trial of an intensive lifestyle intervention (ILI) for patients with type 2 diabetes (T2DM) adapted from Look AHEAD for delivery in routine primary care settings in English and Spanish. Given the high prevalence of T2DM in the Latino population, underrepresentation of this population in research, and disparities in outcomes, we evaluated the experience of Spanish speakers, as compared to English speakers, screened for and enrolled in REAL HEALTH. The trial screened 715 patients who spoke Spanish as a primary language, of whom 17 subjects (8.1% of enrollees, 2.4% of screened Spanish speakers) enrolled in the study. Compared to English speakers, Spanish speakers were less likely to decline participation due to lack of interest (OR 0.43, p<0.01) and equally likely to attend a screening visit (p=0.54) but more likely to be lost to recruitment due to inability to contact the patient for a phone screen (OR 2.0, p<0.01). Engagement of Spanish speakers was lower than among English speakers, with lower rates of completion of the ILI (OR 0.22, p=0.04) and a trend for lower attendance for medical nutrition therapy. Despite this, Spanish-speakers had higher increases in (p=0.01) and final levels of (p=0.03) self-reported physical activity. Weight loss at 12 months in the ILI did not significantly differ between groups (2.8kg among Spanish-speakers vs. 4.8kg among English speakers, p=0.11). It is important to recognize barriers to clinical trial and ILI engagement, as well as the nuances of experiences and outcomes within clinical trials. Enrollment of Spanish speakers was limited by difficulty contacting potential subjects, despite extensive recruitment efforts by study staff. Enrolled participants engaged differently but had similar weight loss compared to English speakers in the ILI. Spanish-speakers represent a unique group who may benefit from tailored interventions.

Disclosure

S. Cromer: Employee; Spouse/Partner; Johnson & Johnson. A.R. Rodriguez: None. L. Bissett: None. A. Dushkin: None. V.M. Goldman: None. J. McCarthy: None. L.M. Delahanty: Advisory Panel; Self; Jana Care Inc., Omada Health, Weight Watchers International, Inc. D.J. Wexler: Other Relationship; Self; Novo Nordisk A/S.

Funding

National Institutes of Health (T32DK007028)
223-OR: Preliminary Evidence that "Structured Eating" (SE) May Be Acceptable and Promote Glycemic Control in Type 1 Diabetes (T1D)
Authors: CRISTELLO ANGELICA , KAHKOSKA ANNA R. , SMART CARMEL E. , COUCH SARAH C. , IGUDESMAN DARIA , KAGER LAUREN , MAYER-DAVIS ELIZABETH J.
Published: June 2020

Research on eating patterns in T1D is scarce, especially in youth. This population is in particular need of effective behavioral strategies during adolescence when HbA1c peaks and lifelong behaviors form. Case studies from pediatric T1D clinics suggest SE (consistent frequency, timing and spacing of meals, snacks and macronutrients throughout the day) is helpful for meeting glycemic targets, yet the health impacts and feasibility of SE as a clinical guideline are not well documented. We developed SE variables and used linear mixed effects models to explore associations between individual SE behaviors and CGM metrics in 24-hr dietary recall and 7-day CGM data of adolescents (n=319, 13-16 yrs, HbA1c 8-13%) from the Flexible Lifestyles Empowering Change (FLEX) intervention. We also conducted a small pilot (n=9, 13-16 yrs, HbA1c 8-13%), “MyPlan”, to explore acceptability of SE. In FLEX, SE behaviors were associated with favorable CGM profile, including time in range (Table 1). In MyPlan, acceptability of SE (scale 0-8) was high among adolescents (mean: 6.8; SE:1.6) and their parents (mean: 7.1 SE: 1.2). Our preliminary evidence suggests benefit and feasibility of SE in adolescents. To inform future trials and ultimately, clinical guidelines, further analyses in diverse samples are needed to more specifically characterize SE patterns and understand their role in T1D health outcomes.

Disclosure

A. Cristello: None. A.R. Kahkoska: Other Relationship; Self; Novo Nordisk A/S. C.E. Smart: None. S.C. Couch: None. D. Igudesman: None. L. Kager: None. E.J. Mayer-Davis: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (1UC4DK101132)
2230-PUB: A Portrait of HbA1c Levels amongst Adults Diagnosed with Diabetes Mellitus in Suburban Ahmedabad
Authors: SHAH SHIVESH , SABOO BANSHI D. , SHAH SHAILIN , HASNANI DHRUVI , CHAVDA VIPUL , KESAVADEV JOTHYDEV , SHAH HARSHAL B. , PATEL KARNIK J.
Published: June 2020

Background: Many studies have estimated the prevalence of type 2 diabetes in suburban regions of India, such as Ahmedabad, Gujarat. However, there are few studies that examine the progression of HbA1C levels in patients diagnosed with diabetes over multiple visits to healthcare facilities.

Objective: The primary aims of this study were to assess the efficacy of patient treatment at a diabetes care center in Gujarat, India and determine factors that may affect the progression of HbA1C levels over multiple visits.

Methods: A total of 2,037 individuals aged ≥25 years (mean age 53.7 years) were included in this retrospective study. All individuals were previously diagnosed with diabetes and received treatment at the Dia Care Advanced Diabetes Care Center in Ahmedabad. Patient data was acquired from the clinic’s HealthPlix EMR.

Results: Of those meeting inclusion criteria, males constituted 69.1%. The average BMI of all subjects was 29.7 kg/m2. Of all 2,037 subjects, only 22.0% (n=442) patients were tested for HbA1C levels multiple times. On average, these subjects underwent blood tests for HbA1C values 3.3 times in a one-year period and HbA1C levels dropped by 0.51 mg/dl (95% CI 0.70-0.31). There was a substantial correlation between the number of clinic visits and the decrease in HbA1C values (R = 0.71). Over the course of one year, 22.6% (19.9-25.1) of subjects who returned to the clinic saw a drop in HbA1C to levels not indicative of diabetes (≤6.5 mg/dl). A significant correlation was observed between RBS measurements and HbA1C levels. Notably, there was also a slight negative correlation between BMI and the number of clinic visits (R = 0.74).

Conclusion: Results from this study reinforce the conventional wisdom that frequent visits to one’s physician help achieve glycemic control. More importantly, these results also reflect the success of suburban clinics such as Dia Care and call for physicians to stress the importance of clinic visits and address improvement in metabolic status regularly.

Disclosure

S. Shah: None. B.D. Saboo: None. S. Shah: None. D. Hasnani: None. V. Chavda: None. J. Kesavadev: Speaker’s Bureau; Self; Biocon, Novo Nordisk Inc., Sanofi-Aventis. H.B. Shah: None. K.J. Patel: None.
2231-PUB: Perioperative Glucose Control Protocol: Hip and Knee Arthroplasty
Authors: PICK ANTHONY , BARALLI JENNIFER D. , SANDHU HARJYOT , KHORZAD REBECA
Published: June 2020

Diabetes and stress hyperglycemia is associated with surgical site infections and other complications. Glucose control may be a modifiable risk factor. Our hospital and healthcare system did not have a standardized protocol for perioperative glucose management. There was variability in pre-surgery diabetes medication adjustments, no proactive glucose monitoring, no glucose control metrics and variable approaches to peri-operative glucose management. We, therefore, initiated a pilot quality improvement project. The population selected were total hip and knee replacement patients as diabetes (∼25%) is a common co-morbidity and there was a signal that diabetes (40% of cases) was associated with deep surgical site infections. The project was an opportunity to implement a population health approach to peri-operative and inpatient glucose management; decrease practice variability and foster a multi-disciplinary team approach. We standardized the recommended adjustments of diabetes medications prior to surgery (e.g., basal insulin decreased 20% the day before surgery); established a uniform A1c threshold of 8% (changed to 7.5%) to postpone surgery and started routine glucose monitoring on the day of surgery in all joint surgery cases. We implemented a standardized correction insulin protocol to be used by anesthesiology and encouraged the use of basal-meal-correction insulin, rather than sliding scale insulin, after surgery, in suitable patients by the hospitalists. The quality project showed a dramatic decrease in hypoglycemia on the day of surgery (∼95% decrease), significantly increased A1c monitoring (3 fold), detected unrecognized diabetes (13%), prediabetes (37%) and stress hyperglycemia and increased the use of correction insulin. Although suggestive, the small sample size and short intervention duration (6 months) were insufficient to detect a significant drop in infection rates. This project is in sustain phase and expanding to other high risk surgeries and can be a model for the entire system.

Disclosure

A. Pick: None. J.D. Baralli: None. H. Sandhu: None. R. Khorzad: None.
2237-PUB: Diabetes Inside: Regional Collaborative to Improve DM and CVD Care Quality
Authors: FURMAN ROY E. , HILL-BRIGGS FELICIA , IWAMAYE AMY , KNIGHT COLETTE , KOUVATSOS TASHA , LEV YAIR , LORINCZ ILONA , MARELLA WILLIAM M. , RUBIN DANIEL J. , SCHUTTA MARK H. , SWAVELY DEBORAH A. , WARD LAWRENCE , FURMAN ELISE C. , LIPTAK GREG
Published: June 2020

The American Diabetes Association (ADA) and the American Heart Association launched a multi-faceted national partnership in 2018, Know Diabetes by Heart™, to reduce cardiovascular disease (CVD) deaths, heart attacks and strokes in people living with type 2 diabetes.

To support this initiative, the ADA’s Diabetes INSIDE® (DI) program formed a mid-Atlantic quality improvement (QI) collaborative of five academic medical centers and a health information exchange (HIE) with partners from primary care, endocrinology, cardiology, nephrology, nursing, pharmacy, health IT, diabetes education, population health and industry. The collaborative’s goal is to accelerate clinical adoption of recent CVD findings using population health analytics, care system redesign, shared learning, provider and patient training, education, and community resources.

DI works with each partner to identify, design and monitor quantifiable QI programs to address care quality gaps. The collaborative shared their initial findings and goals at a November 2019 meeting.

Three systems identified opportunities to improve low use of SGLT2 inhibitors and GLP-1 agonists in eligible patients (∼12%) or departmental prescribing gaps between primary care and cardiology vs. endocrinology (SGLT2 5% vs. 11%; GLP-1 7.5% vs. 24.6%). Other gaps included coordinating care teams and communication between inpatient and outpatient settings both within and across overlapping health systems, a gap the HIE aims to address. Other systems are implementing DM screening in cardiology clinics or training cardiologists to assume a larger role in managing patients with DM and CVD. A system with a large racial/ethnic minority population is qualitatively evaluating the social, cultural, economic, and literacy factors that facilitate or inhibit optimal care. This regional collaborative across overlapping health systems offers increased opportunity to accelerate improvement of DM and CVD care for all patients and may serve as a model for other regions.

Disclosure

R.E. Furman: None. F. Hill-Briggs: None. A. Iwamaye: None. C. Knight: None. T. Kouvatsos: None. Y. Lev: None. I. Lorincz: None. W.M. Marella: None. D.J. Rubin: None. M.H. Schutta: Employee; Spouse/Partner; Merck & Co., Inc. D.A. Swavely: None. L. Ward: None. E.C. Furman: None. G. Liptak: Employee; Spouse/Partner; Janssen Pharmaceuticals, Inc.

Funding

Know Diabetes By Heart™; Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance; Novo Nordisk; Sanofi; AstraZeneca; Bayer
2245-PUB: Insulin Pump Access to Low-Income Pediatric Patients with Type 1 Diabetes Living in Massachusetts
Authors: BONETTI IVANA , SEGAL ALISSA R. , MARCUS GAIL
Published: June 2020

Purpose: To evaluate whether low-income pediatric patients with type-1 diabetes living in Massachusetts experience disparities in access to insulin pumps and if there are disparities, what are the root causes.

Methods: The first part of this study was a literature review to identify access disparities and any barriers experienced by the population. The second part of this study was interviewing stakeholders in Massachusetts who have insight on this topic. Stakeholders in this study are defined as experts who have an impact or interaction with the investigated population. A snowballing method of sampling method was used where stakeholders were asked to refer someone. The stakeholders consisted of physicians (33%), nurses/educators (33%), pump representatives/trainer (17%), and health insurance workers (17%). A transcription tool, NVivo™, was used to search for common themes among the interviews.

Results: Common barriers were identified as: economics, social factors, developmental stage, education level and patient-provider assessment. Economically, patients encountered unaffordable copays and extensive paperwork. Socially, patients feared embarrassment and admission of their diagnosis. Younger patients, usually children under an adolescent age, are commonly denied a pump due to the lack of management control and physical discomfort with pump attachment. Lack of education from guardians and/or patients operating a pump limited access and influenced opting out. Provider assessment of the patient’s glycemic control also determined pump access.

Conclusion: Findings from this study have confirmed that there is an access gap for this population in Massachusetts. Access to pumps have been found to be influenced by the following barriers: economics, social factors, developmental stage, education level and patient-provider assessment.

Disclosure

I. Bonetti: None. A.R. Segal: None. G. Marcus: None.

Funding

Massachusetts College of Pharmacy and Health Sciences