bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy and Safety of Ertugliflozin in Patients With Type 2 Diabetes Mellitus and Established Cardiovascular Disease Using Insulin
Authors: Lingvay Ildiko , Greenberg Michelle D , Gallo Silvina , Shi Harry , Liu Jie , Gantz Ira 
Published: May 2021

Abstract
Introduction: Ertugliflozin (ERTU), a sodium-glucose cotransporter 2 inhibitor, is approved as an adjunct to diet and exercise to improve glycemic control in patients (pts) with type 2 diabetes mellitus (T2DM). Aim: As part of the VERTIS CV trial (NCT01986881), the efficacy and safety of ERTU were assessed in pts with T2DM and established atherosclerotic cardiovascular disease (ASCVD) inadequately controlled by insulin. Methods: Pts were randomly assigned to placebo (PBO), ERTU 5 mg or 15 mg once daily. A pre-specified sub-study was conducted in pts on a stable dose of insulin ≥20 units/day (± metformin). The primary endpoint was HbA1c change from baseline at 18 weeks. Key secondary endpoints included proportion of patients achieving HbA1c &lt;7%, fasting plasma glucose (FPG), body weight (BW), and systolic blood pressure (SBP). Changes from baseline at Week 18 for continuous efficacy endpoints were assessed using a constrained longitudinal data analysis model. HbA1c reduction was also assessed in subgroups based on baseline HbA1c, age, sex, race, ethnicity, and use of metformin. Results: Of 8246 pts randomized in VERTIS CV, 1065 pts (ERTU 5 mg: 348; ERTU 15 mg: 370; PBO: 347) with T2DM and ASCVD were included in the sub-study. Mean baseline characteristics were similar across treatment groups; age 64.8 years, T2DM duration 16.7 years, HbA1c 8.4%, and eGFR 73.7 mL/min/1.73 m2. At baseline, 40.6% of pts were on insulin alone, 59.4% were receiving insulin + metformin; median (range) insulin dose was 58.0 (20–350) units/day. At Week 18, least squares mean change (95% confidence interval) from baseline in HbA1c was significantly greater with ERTU 5 mg and 15 mg vs PBO. PBO-adjusted differences were −0.6% (−0.7, −0.4) and −0.7% (−0.8, −0.5), for ERTU 5 mg and 15 mg, respectively (P&lt;0.001 for both). HbA1c reductions were greater with ERTU vs PBO for all subgroups including by use of metformin. At Week 18, 10.7%, 20.7%, and 21.1% of pts with PBO, ERTU 5 mg and 15 mg, respectively, achieved HbA1c &lt;7.0%. ERTU 5 mg and 15 mg significantly reduced FPG, BW, SBP, and ERTU 15 mg led to a small reduction in total daily insulin dose. The overall incidence of adverse events and serious adverse events was similar across treatment groups. In women, the incidences of genital mycotic infections was higher with ERTU 5 mg (3.4%; P=0.05) and ERTU 15 mg (3.6%; P=0.04) vs PBO (0.0%). The incidences of urinary tract infections (3.2–4.1%), symptomatic hypoglycemia (26.4–28.5%), and severe hypoglycemia (3.5–5.1%) were similar across treatment groups. The incidences of hypovolemia were low (1.4–2.4%) and similar across treatment groups. Conclusion: ERTU added to insulin (± metformin) led to greater reductions from baseline in HbA1c, FPG, BW, and SBP, and a higher proportion of pts achieving HbA1c &lt;7.0%, vs PBO at 18 weeks in pts with T2DM and ASCVD, without increasing the risk of hypoglycemia.
Improving Glycemic Control of Diabetic Patients in an Outpatient Practice
Authors: Gibbs Otto T , Otuonye Gene C , Sammour Ahmed H , Aguasvivasbello Marnie , Williams Karlene D 
Published: May 2021

Abstract
Diabetes Mellitus (DM) is a devastating condition with premature mortality, poor quality of life, & vast economic cost contributing to substantial societal burden. More resources are allocated to DM than any other condition, & with an estimated worldwide prevalence of 350 million people by 2025, it remains an urgent epidemic. Providing standardized, high quality care (HQC) to improve DM control is a matter of utmost importance. Our residents receive primary care training in a federal funded healthcare system, with yearly reports from Medicare addressing compliance with current accepted standards, including but not limited to DM management. In this Quality Improvement (QI) project, we sought to directly address deficiencies in their management.
A retrospective chart review was conducted over 1 year. Patients with uncontrolled (UC) DM were identified & a root cause analysis conducted. It was noted that over 40% of diabetics were UC, with a hemoglobin A1c (HbA1c) &gt;8%; 60% of whom did not have appropriate escalation of management (AEOM) in further encounters. A QI intervention was developed aiming to improve AEOM in patients. Plan-Do-Study-Act cycles focused on the creation of a standardized documentation system (SDS) for UC DM encounters, a tracking system & a designated “DM manager”, who ensured electronic prescription delivery & early follow-up (F/U) appointments. Clear metrics of AEOM were established & clinicians underwent small group educational sessions emphasizing each intervention, with review of updated ADA guidelines. Although prospective biweekly chart review is ongoing, Fisher’s exact test was used for statistical analysis of initial post interventional data.
A total of 33 UC DM patient encounters were analyzed thus far. In January 2020, 31% of all encounters used the newly created SDS; of which 69% had AEOM. In February 2020, 57% of all encounters used the SDS; 71% of providers had AEOM. Of the encounters using the SDS, 83% had AEOM compared to 67% in those without (p:0.42). Average F/U time per patient was 6 weeks.
Delivering standardized & HQC in DM patients presents a challenge dependent on a variety of system & patient factors. This becomes more apparent in rural & low-income populations as in our clinic. Although HbA1c is a well-established method of monitoring glycemic control, we propose that other uniform performance measures be used to dynamically assess overall DM management. Our metrics include standardized, replicable documentation, early F/U time & defined AEOM parameters such as timely addition of new medication, dose adjustments, & utilization of resources such as DM educators. Thus far, there appears to be a non-statistically significant trend towards improved standardization of provider documentation, F/U visits & AEOM. Further data is needed. We hope to see these measures translate into overall improved glycemic control.
A Case Series of Hyperglycemic Hyperosmolar State During the Global COVID-19 Pandemic
Authors: Hoag Benjamin Donald , Knoll Michelle , Paprocki Emily 
Published: May 2021

Abstract
Hyperglycemic hyperosmolar state (HHS) is rare in pediatrics, particularly in patients with antibody positive diabetes mellitus (DM). Recent literature has implicated COVID-19 in the reported increase in new-onset DM cases, as well as mixed diabetic ketoacidosis (DKA) and HHS cases, however a rise in HHS cases alone has not been well reported [1,2]. We noted an anecdotal increase in the frequency of HHS cases in our pediatric tertiary care center following the onset of the global COVID-19 pandemic. To investigate further, a retrospective chart review evaluating all patients with DM admitted in the first 6 months of 2019 and the first 6 months of 2020 was conducted. A diagnosis of HHS was defined as a blood glucose over 600 mg/dL with a serum osmolality (calculated or measured) greater than 320 mOsm/kg on initial laboratory evaluation. Patients with DKA, defined as a serum bicarbonate level less than 16 mmol/L with evidence of significant ketosis (serum ketones greater than 3 mmol/L), were excluded from the study. During the first 6 months of 2019, 1 patient met inclusion criteria. However, the diagnosis of HHS was complicated by a concurrent diagnosis of diabetes insipidus, which may have contributed to the hyperosmolar state, and a nonketotic lactic acidosis. Five HHS cases were noted in the first 6 months of 2020, 4 of which occurred in May and June. For the 2020 HHS cohort, the average patient age ± SD was 12 ± 3.34 years. The mean ± SD laboratory values included bicarbonate 18.2 ± 1.64 mmol/L, serum blood glucose 776.8 ± 30.75 mg/dL, calculated serum osmolality 328 ± 4.18 mOsm/kg, and HgA1C 12.72 ± 1.16%. All 5 patients in the 2020 cohort had new-onset DM, with 4 of the 5 patients having at least 1 positive DM antibody (GAD antibodies were positive in 3, ICA/IA-2 antibodies in 2, and Zinc Transporter 8 antibodies in 1). No patients displayed COVID-19 symptoms, and only 1 patient was tested for COVID-19 by PCR, which returned negative. However, SARS-CoV2 antibody testing was not available, and it is unknown if these patients had prior COVID-19 illness. In conclusion, we noted an increased incidence of HHS at our hospital, particularly among new-onset, antibody positive DM patients during the initial months of the COVID-19 pandemic. Further study and investigation are needed to determine the cause of this increased local incidence, and if infectious, social, or economic influences related to the COVID-19 pandemic contributed. References: [1] Chan, K.H., et al., Clinical characteristics and outcome in patients with combined diabetic ketoacidosis and hyperosmolar hyperglycemic state associated with COVID-19: A retrospective, hospital-based observational case series. Diabetes Res Clin Pract, 2020. 166: p. 108279. [2] Unsworth, R., et al., New-Onset Type 1 Diabetes in Children During COVID-19: Multicenter Regional Findings in the U.K. Diabetes Care, 2020.
An Observational Study on Glycemic Outcomes, Lifestyle and Psychosocial Health of Patients With Diabetes During Covid-19 Lockdown From Bangalore
Authors: Selvarajan Raja , Jaganmohan Balaji , Vijayaraghavan Radhika 
Published: May 2021

Abstract
Background and Aims:
Lockdown during the COVID-19 pandemic imposed many restrictions on the public. Loss of continuum of care along with improper lifestyle was expected to worsen glycemic control in people with type 2 diabetes (T2D). We aimed to identify the effects of lockdown on their glycemic status, lifestyle changes and psychosocial health.
Methods:
The pre- and post-lockdown data of 110 adults with T2D who were under regular follow up was collected by direct interview during their visit to the diabetes clinic. The variables analyzed included demographic data, HbA1c, body weight, lifestyle changes, psychosocial factors and use of technology.
Result:
The overall physical activity had dipped significantly accounting to lockdown restrictions and fear. Dietary adherence was better with participants exhibiting increased consumption of vegetables (80.9%), fruits (42.7%), and decreased unhealthy snacking (63%). 90% of them had access to medications during lockdown. There was significant change noted in the mean HbA1c (0.9- 1.45%) and body weight (1–3.5kgs) before and after lockdown. There was a great increase in Screen time attributing to Work from home and restrictions to move out. 63.6% of them spent time with their family members. Those with prior mental stress,poor sleep and unhealthy dietary habits had worsening glycemic control as seen in those with less physical activity and an unhealthy diet. An increasing trend of utilisation of health related mobile internet technology apps were noted.
Conclusion:
Lockdown did cause a major change in the overall glycemic control. Measures to promote healthy lifestyle practices along with ways to reduce psychosocial stress must be implemented for better T2D management during such restricted times. Telemedicine paved a greater way and scope of continuum of Diabetes care.
How Did Elderly T2D Patients Cope With the Quebec Covid-19 Lockdown
Authors: Elstein Jack , Gilfix Reisa , Elstein Eleanor 
Published: May 2021

Abstract
The Canadian city most affected by the first wave of the Covid-19 (CV19) pandemic was Montreal. Montreal was in lockdown (LD) from Mar 13- Jun 15, 2020. The elderly, diabetics, and the economically disadvantaged are among the groups most at risk of CV19 and the psychosocial effects of LD. We sought to ascertain the effect of the LD on the wellbeing of lower income elderly T2D pts. As we felt it unethical to do non-essential testing during a pandemic we relied on clinically available HbA1c’s as surrogates for metabolic wellbeing. Most HbA1c‘s used reflect a high (r=0.91) correlation with 3 month values for the time periods of interest. The study group was composed of 38 mostly elderly T2D pts. All pts lived alone or with similarly aged spouses in non-institutional settings in a lower middle class neighborhood of Montreal. None had organized domestic help from family or the community. None had documented acute medical episodes or medication changes between Jan and Sept 2020. None have conditions known to render HbA1c non reliable. Pts were interviewed by telephone to assess their overall coping with the LD. In particular they were questioned about medical issues, difficulties obtaining medications +/- groceries and psychological or social stress. HbA1c values between Jan 1 - Mar 15, 2020 and after Aug 25, 2020 (non LD values) and between Apr 20 - Aug 15, 2020 (LD values) were recorded. Differences in the recorded non LD and LD HbA1c’s were compared and analyzed for the group as a whole, by gender, and by insulin use. There were 38 pts, 22 M 56–77 yrs (mean 72.1) and 16 F 41–90 yrs (mean 75.2), 89.5% (34/38) were &gt; 65 yrs. Ten M and 9 F were on insulin. No pt reported severe hypoglycemia or weight fluctuations. All claimed to be following public health guidelines. There were no significant differences (d) between the mean HbA1c’s non LD compared to LD neither for the entire group (d= 0.2), M (d=0.2), F (d=0.2), insulin treated pts (d=0.3) nor those not treated with insulin (d=0.0). There were no overt medical decompensations. No pt reported having been unable to access medications or groceries. No pt reported significant psychological distress or feelings of isolation. None had been diagnosed with CV19. This largely geriatric T2D cohort did not report any overt deleterious effects from the LD. There were no significant differences in HbA1c non LD compared to LD. It is not possible to determine how effective the LD was in protecting these pts from CV19 other than to note that none had been diagnosed as having contracted the disease. As the 2nd wave of CV19 evolves, health care professionals will have the opportunity to study the effect of public health interventions, not only on controlling the spread of CV19, but also on the general wellbeing of different pt populations.
Hyperglycemia Is Associated With Increased Mortality in Critically Ill Patients With COVID-19
Authors: Bass* Ilana R , Mazori* Alon , Chan Lili , Mathews Kusum , Altman Deena , Saha Aparna , Soh Howard , Wen Huei Hsun , Bose Sonali , Leven Emily , Wang Jing Gennie , Mosoyan Gohar , Pattharanitima Pattharawin , Greco Giampolo , Gallagher Emily Jane 
Published: May 2021

Abstract
Objective: To explore the relationship between diabetes mellitus (DM), hyperglycemia, and adverse outcomes in critically ill patients with coronavirus disease 2019 (COVID-19).
Research Design and Methods: The study population comprised 133 patients with COVID-19 admitted to an intensive care unit (ICU) at an academic, urban, quaternary-care center between March 10th and April 8th, 2020. Patients were categorized based on the presence of DM and early-onset hyperglycemia (EHG), defined as a blood glucose &gt;180 mg/dL during the first two days of ICU admission. The primary outcome was 14-day in-hospital mortality; also examined were 60-day in-hospital mortality and the levels of C-reactive protein (CRP), interleukin 6, procalcitonin, and lactate. Results: Compared to non-DM patients without EHG, non-DM patients with EHG exhibited higher adjusted hazard ratios (HR) for in-hospital mortality at 14 days (HR 5.76, p=0.008) and 60 days (HR 7.28, p=0.004). Non-DM patients with EHG also featured higher levels of mean CRP (322.3±177.7 mg/L, p=0.036), procalcitonin (34.75±69.33 ng/mL, p=0.028), and lactate (2.7±2.1 mmol/L, p=0.023). Conclusions: In patients with critical illness from COVID-19, those without DM with EHG were at greatest risk of 14-day and 60-day in-hospital mortality. The limitations of our study include its retrospective design, and relatively small cohort. However, our results raise the possibility that the combination of elevated glucose and lactate may identify a specific cohort of individuals at high mortality risk from COVID-19, and suggest that glucose testing and control are important in individuals with COVID-19, even in those without pre-existing diabetes.
Impact of Covid19 Lockdown on Glycemic Control
Authors: Rodriguez Giovanna , Bahtiyar Mert , Kirupakaran Johnathan , Kubbar Alaa , Singh Shikha , Karnik Suruchi , Hashmi Syed Salman , Bahtiyar Gul 
Published: May 2021

Abstract
Evidence shows that people with poor glycemic control are at greater risk of mortality due to Covid19. It is important to achieve and maintain good glycemic control to prevent negative outcomes during this pandemic (1). To study the effect of lockdown on glucose control we conducted an observational, retrospective cohort study involving 98 patients followed at endocrine clinic at an inner city, community hospital in Brooklyn, NY in the period February to May 2020. Of the cohort, 60% were women, mean age was 54.1 + 15.3 years, 70% was Hispanic, 24% was African American with a predominance of type 2 diabetes (86%). Mean HbA1c of prelockdown and lockdown phase was 9.77 ± 2.26% and 9.49 ± 2.17 % respectively and the difference was statistically significant (p &lt; 0.001) both in patients with Type 1 and Type 2 diabetes. Mean BMI of prelockdown and lockdown phase was 30.5 ± 6.8% and 30.1 ± 6.05% respectively and the difference was not statistically significant (p = 0.33). Despite no significant change in BMI, the factors responsible for improvement in HbA1c might be a result of refined eating patterns (increased consumption of homemade food), increased adherence to medication and time to cope with the daily challenges of diabetes management (1). Reference: Maddaloni E, Coraggio L, Pieralice S, Carlone A, Pozzilli P, Buzzetti R. Effects of COVID-19 Lockdown on Glucose Control: Continuous Glucose Monitoring Data From People With Diabetes on Intensive Insulin Therapy. Diabetes Care Aug 2020, 43 (8) e86-e87; DOI: 10.2337/dc20-0954
Implementation of a Continuous Glucose Monitoring Program at a Safety Net Hospital During Covid 19 Pandemic
Authors: Finn Erin E , Schlichting Lindsay , Pereira Rocio Ines 
Published: May 2021

Abstract
Background: COVID 19 disproportionately impacts individuals with diabetes leading to increased morbidity and mortality. Hyperglycemia is common in hospitalized patients with COVID requiring intensive monitoring and management. Close monitoring of glucoses requires increased use of personal protective equipment (PPE), which has been in limited supply since the beginning of the pandemic. The FDA granted conditional allowance for use of continuous glucose monitors (CGM) in hospital settings during the COVID pandemic to allow for preservation of PPE. We present the process of implementing a continuous glucose monitoring program in an urban safety net hospital.
Methods: The program was implemented at a county urban safety net hospital. Patients were eligible to be started on Dexcom G6 CGM if they had hyperglycemia requiring multiple insulin injections daily, were in contact isolation, and were located in 1 of 3 units of the hospital (medical intensive care unit [MICU], surgical intensive care unit, COVID 19 floor unit). Initial program was started in the MICU and subsequently expanded. Nurses and staff underwent training using videos, in-person demonstrations, and written guides. Informational Technology modified the electronic medical system to allow for ordering and documentation of CGM values by nurses. Supplies were stored both on unit and in central supply allowing for primary team to initiate monitoring independent of diabetes team. Records of patients participating in program were maintained by the diabetes team. Amount of PPE saved was estimated to be 10 instances/day while on insulin drip and 3/day when using subcutaneous insulin.
Results: A total of 69 patients used a CGM during their hospital course. Average age was 56 years old, 69 % were male, average BMI 31, and 84% had known diabetes prior to admission. The majority of patients were critically ill with 68% intubated, 48% on vasopressors, 6% requiring dialysis, 38% on insulin drip, 46% were on tube feeds, and 74% received steroids. The racial demographics of the patients were 72% White, 3% Black, 4% Native American, 4% Asian, and 14% other. For ethnicity, 73% identified as Hispanic and half spoke Spanish as their primary language. An estimated 2600 instances of PPE were saved. Challenges that were faced in implementing the program included consistent training of large numbers of staff, maintaining supplies in stock, troubleshooting discordant values, and restricting use of CGM to patients who met qualifications.
Conclusion: Overall, the implementation of CGM was successful and received a positive response. Staff in the primary units quickly became comfortable with the application of the technology. Potential challenges in the future include ongoing training, improving troubleshooting of technology, validating the accuracy of the devices, and developing funding for CGM equipment and interpretation.