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Background: The COVID-19 pandemic necessitated rapid implementation of continuous glucose monitoring (CGM) in the intensive care unit (ICU). Although rarely reported, perceptions from nursing staff who used the systems are critical for successful implementation and future expanded use of CGM in the inpatient setting. Methods: A 22-item survey focused on CGM use was distributed to ICU nurses at two large academic medical centers in the United States in 2022. Both institutions initiated inpatient CGM in the spring of 2020 using the same CGM+point of care (POC) hybrid protocol. The survey employed a 1- to 5-point Likert scale regarding CGM sensor insertion, accuracy, acceptability, usability, training, and perceptions on workload. Results: Of the 71 surveys completed, 68 (96%) nurses reported they cared for an ICU patient on CGM and 53% reported they had independently performed CGM sensor insertion. The ICU nurses overwhelmingly reported that CGM was accurate, reduced their workload, provided safer patient care, and was preferred over POC glucose testing alone. Interestingly, nearly half of nurses (49%) reported that they considered trend arrows in dosing decisions although trends were not included in the CGM+POC hybrid protocol. Nurses received training through multiple modalities, with the majority (80%) of nurses reporting that CGM training was sufficient and prepared them for its use. Conclusion: These results confirm nursing acceptance and preference for CGM use within a hybrid glucose monitoring protocol in the ICU setting. These data lay a blueprint for successful implementation and training strategies for future widespread use.

Traditionally, the care of critically ill patients with diabetes or stress hyperglycemia in the intensive care unit (ICU) demands the use of continuous intravenous insulin (CII) therapy to achieve narrow glycemic targets. To reduce the risk of iatrogenic hypoglycemia and to achieve glycemic targets during CII, healthcare providers (HCP) rely on hourly point-of-care (POC) arterial or capillary glucose tests obtained with glucose monitors. The burden of this approach, however, was evident during the beginning of the pandemic when the immediate reduction in close contact interactions between HCP and patients with COVID-19 was necessary to avoid potentially life-threatening exposures. Taking advantage of the advancements in current diabetes technologies, including continuous glucose monitoring (CGM) devices integrated with digital health tools for remote monitoring, HCP implemented novel protocols in the ICU to care for patients with COVID-19 and hyperglycemia. We provide an overview of research conducted in the ICU setting with the use of initial CGM technology to current devices and summarize our recent experience in the ICU.

The annual Virtual Hospital Diabetes Meeting was hosted by Diabetes Technology Society on April 1 and April 2, 2022. This meeting brought together experts in diabetes technology to discuss various new developments in the field of managing diabetes in hospitalized patients. Meeting topics included (1) digital health and the hospital, (2) blood glucose targets, (3) software for inpatient diabetes, (4) surgery, (5) transitions, (6) coronavirus disease and diabetes in the hospital, (7) drugs for diabetes, (8) continuous glucose monitoring, (9) quality improvement, (10) diabetes care and educatinon, and (11) uniting people, process, and technology to achieve optimal glycemic management. This meeting covered new technology that will enable better care of people with diabetes if they are hospitalized.

OBJECTIVE The efficacy and safety of continuous glucose monitoring (CGM) in adjusting inpatient insulin therapy have not been evaluated. RESEARCH DESIGN AND METHODS This randomized trial included 185 general medicine and surgery patients with type 1 and type 2 diabetes treated with a basal-bolus insulin regimen. All subjects underwent point-of-care (POC) capillary glucose testing before meals and bedtime. Patients in the standard of care (POC group) wore a blinded Dexcom G6 CGM with insulin dose adjusted based on POC results, while in the CGM group, insulin adjustment was based on daily CGM profile. Primary end points were differences in time in range (TIR; 70–180 mg/dL) and hypoglycemia ( RESULTS There were no significant differences in TIR (54.51% ± 27.72 vs. 48.64% ± 24.25; P = 0.14), mean daily glucose (183.2 ± 40 vs. 186.8 ± 39 mg/dL; P = 0.36), or percent of patients with CGM values CONCLUSIONS The inpatient use of real-time Dexcom G6 CGM is safe and effective in guiding insulin therapy, resulting in a similar improvement in glycemic control and a significant reduction of recurrent hypoglycemic events compared with POC-guided insulin adjustment.

Nonalcoholic steatohepatitis (NASH) is an increasingly common etiology for liver-related hospitalizations in the United States. The aim of this study was to examine the differences of disease characteristics and outcomes between hospitalized Black and White patients with NASH.We used the National Inpatient Sample (NIS) to identify all adult hospitalizations with NASH (ICD-10 code: K75.81) from 2016 to 2018. We compared demographic and clinical characteristics between Black and White patients. Multivariable models were computed to compare all-cause mortality, length of stay (LOS), and total hospital costs between the groups.There were 43,409 hospitalizations with NASH (41,143 White, 2266 Black). Black patients were less likely to have cirrhosis (33.6%) compared with Whites (56.4%), P0.0001. Black patients were less likely to have esophageal variceal bleeding (1.2% vs. 3.5%), ascites (17.1% vs. 28.8%), and acute liver failure (16.2% vs. 28.9%) compared with Whites (all P0.0001). These findings were consistent among patients with cirrhosis. Mortality was higher among Blacks compared with Whites (3.9% vs. 3.7%, adjusted odds ratio=1.34; 95% confidence interval: 1.05-1.71, P=0.018). Compared with Whites, Blacks had a longer LOS (6.3 vs. 5.6, P0.001), and higher hospital costs ($18,602 vs. $17,467; P=0.03).In this large population of inpatients with NASH, Black patients were less likely to have cirrhosis and liver disease-related complications, but had overall worse hospital mortality, longer LOS, and higher hospital costs. Further research is warranted to elaborate on factors that generate the health inequities in NASH outcomes between Black and White patients.

This article is the work product of the Continuous Ketone Monitoring Consensus Panel, which was organized by Diabetes Technology Society and met virtually on April 20, 2021. The panel consisted of 20 US-based experts in the use of diabetes technology, representing adult endocrinology, pediatric endocrinology, advanced practice nursing, diabetes care and education, clinical chemistry, and bioengineering. The panelists were from universities, hospitals, freestanding research institutes, government, and private practice. Panelists reviewed the medical literature pertaining to ten topics: (1) physiology of ketone production, (2) measurement of ketones, (3) performance of the first continuous ketone monitor (CKM) reported to be used in human trials, (4) demographics and epidemiology of diabetic ketoacidosis (DKA), (5) atypical hyperketonemia, (6) prevention of DKA, (7) non-DKA states of fasting ketonemia and ketonuria, (8) potential integration of CKMs with pumps and automated insulin delivery systems to prevent DKA, (9) clinical trials of CKMs, and (10) the future of CKMs. The panelists summarized the medical literature for each of the ten topics in this report. They also developed 30 conclusions (amounting to three conclusions for each topic) about CKMs and voted unanimously to adopt the 30 conclusions. This report is intended to support the development of safe and effective continuous ketone monitoring and to apply this technology in ways that will benefit people with diabetes.

AIMS: Limited data exists about the use of insulin degludec in the hospital. This multicentre, non-inferiority, open-label, prospective randomised trial compared the safety and efficacy of insulin degludec-U100 and glargine-U100 for the management of hospitalized patients with type 2 diabetes. METHODS: A total of 180 general medicine and surgery patients with an admission blood glucose (BG) between 7·8 – 22·2 mmol/L, treated with oral agents or insulin prior to hospitalization were randomly allocated (1:1) to a basal bolus regimen using degludec (n=92) or glargine (n=88), as basal and aspart before meals. Insulin dose was adjusted daily to a target BG between 3·9 – 10·0 mmol/L. The primary end point was difference in the mean hospital daily BG between groups. RESULTS: Overall, the randomization BG was 12·2 ± 2·9 mmol/L and HbA1c 84 mmol/mol (9·8±2·0%). There were no differences in mean daily BG (10·0±2·1 vs. 10·0±2·5 mmol/L, p=0·9), proportion of BG in target range (54·5± 29% vs. 55·3 ± 28%, p=0·85), basal insulin (29·6 ± 13 vs 30·4 ± 18 units/day, p=0·85), length of stay (median (IQR): 6·7 (4·7–10·5) vs. 7·5 (4·7–11·6) days, p=0·61), hospital complications (23% vs. 23%, p=0·95) between treatment groups. There were no differences in the proportion of patients with BG

OBJECTIVE Advances in continuous glucose monitoring (CGM) have transformed ambulatory diabetes management. Until recently, inpatient use of CGM has remained investigational, with limited data on its accuracy in the hospital setting. RESEARCH DESIGN AND METHODS To analyze the accuracy of Dexcom G6, we compared retrospective matched-pair CGM and capillary point-of-care (POC) glucose data from three inpatient CGM studies (two interventional and one observational) in general medicine and surgery patients with diabetes treated with insulin. Analysis of accuracy metrics included mean absolute relative difference (MARD), median absolute relative difference (ARD), and proportion of CGM values within 15, 20, and 30% or 15, 20, and 30 mg/dL of POC reference values for blood glucose >100 mg/dL or ≤100 mg/dL, respectively (% 15/15, % 20/20, % 30/30). Clinical reliability was assessed with Clarke error grid (CEG) analyses. RESULTS A total of 218 patients were included (96% with type 2 diabetes) with a mean age of 60.6 ± 12 years. The overall MARD (n = 4,067 matched glucose pairs) was 12.8%, and median ARD was 10.1% (interquartile range 4.6, 17.6]. The proportions of readings meeting % 15/15, % 20/20, and % 30/30 criteria were 68.7, 81.7, and 93.8%, respectively. CEG analysis showed 98.7% of all values in zones A and B. MARD and median ARD were higher in the case of hypoglycemia ( CONCLUSIONS Our results indicate that CGM technology is a reliable tool for hospital use and may help improve glucose monitoring in non–critically ill hospitalized patients with diabetes.

Background: The efficacy and safety of continuous glucose monitoring (CGM) in adjusting inpatient insulin therapy has not been evaluated. Methods: This randomized trial included 185 general medicine and surgery patients with type 1 and type 2 diabetes treated with a basal bolus insulin regimen. All subjects underwent point-of-care (POC) capillary glucose testing before meals and bedtime. Patients in the standard of care (POC group) wore a blinded Dexcom G6 CGM with insulin dose adjusted based on POC results; while in the CGM group, insulin adjustment was based on daily CGM profile. Primary endpoints were differences in time in range (TIR, 70-180 mg/dL) and hypoglycemia ( Results: There were no significant differences in TIR (54.51%±27.72 vs 48.64%±24.25, p=0.14), mean daily glucose (183.2±40 mg/dL vs 186.8±39 mg/dL, p=0.36), percent of patients with CGM values Conclusion: The inpatient use of real-time Dexcom G6 CGM is safe and effective in guiding insulin therapy resulting in a similar improvement in glycemic control and a significant reduction of recurrent hypoglycemic events compared to POC-guided insulin adjustment.

Objective: Administration of supplemental sliding scale insulin (SSI) for correction of hyperglycemia in non-ICU patients with type 2 diabetes is frequently used with basal-bolus insulin regimens. This non-inferiority randomized controlled trial tested whether glycemic control is similar with and without aggressive SSI before meals and bedtime in patients treated with basal-bolus insulin regimens. Research Design and Methods: Patients with type 2 diabetes, with admission blood glucose (BG)140-400 mg/dl treated with basal-bolus insulin were randomized to Intensive (correction for BG>140 mg/dl, n=108) or to Non-Intensive (correction for BG>260 mg/dl, n=107) administration of rapid-acting SSI before meals and bedtime. Both groups received the same amount of SSI for BG>260 mg/dl. Primary outcome was difference in mean daily BG levels between the groups during hospitalization. Results: Mean daily BG in the Non-Intensive group was non-inferior to BG in the Intensive group with equivalence margin of 18 mg/dl (Intensive: 172±38 mg/dl vs Non-Intensive: 173±43 mg/dl, p=0.001 for non-inferiority). There were no differences in the proportion of target BG readings of 70-180 mg/dl, hypoglycemia (350 mg/dl), or total, basal or prandial insulin doses. Significantly fewer subjects received SSI in the Non-Intensive (n=36,34%) compared to the Intensive group (n=98,91% [p Conclusions: Among non-ICU patients with type 2 diabetes on optimal basal-bolus insulin regimen with moderate hyperglycemia (BG

IDegLira-HIGH trial was a non-inferiority, prospective, randomized clinical trial, comparing the efficacy and safety of insulin degludec/liraglutide combination (IDegLira) and a regimen of multiple daily injections (MDI) with basal-bolus insulin (BB) in adults (>18-80 years of age) , with type 2 diabetes (T2D) , and very high HbA1c (>9%-15%) , previously treated with basal insulin or multiple oral agents. Primary endpoint was change in HbA1c from baseline to week 26. Secondary endpoints included incidence of hypoglycemia, changes on weight and glycemic variability (% coefficient of variation [%CV]) . Treatment with IDegLira and BB insulin resulted in similar improvement in glycemic control: 7.7±1.7% and 7.7±1.5%, (p=0.76) , with a reduction from baseline of -3.2±2.3% and -3.0±1.8%, (p=0.39) at 26-weeks. IDegLira resulted in lower rates of hypoglycemia Disclosure R.J.Galindo: Advisory Panel; Sanofi, WW International, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk. G.E.Umpierrez: Research Support; AstraZeneca, Dexcom, Inc., Novo Nordisk. B.Moazzami: None. M.F.Scioscia: None. P.Vellanki: n/a. G.M.Davis: Consultant; Medscape, Research Support; Insulet Corporation. F.J.Pasquel: Consultant; AI Health LLC, Boehringer Ingelheim International GmbH, Dexcom, Inc., Research Support; Dexcom, Inc., Insulet Corporation, Merck & Co., Inc. M.Fayfman: None. A.L.Migdal: None. J.Saling: None. Funding Investigator-initiated study to Emory University (PI. Dr. Rodolfo J. Galindo) from Novo Nordisk.

Few studies have reported on differences in glycemic control and glucose variability by continuous glucose monitoring (CGM) in hospitalized insulin-treated older adults with type 2 diabetes (T2D) . Accordingly, we combined data from 3 inpatient randomized clinical trials using CGM in insulin-treated patients with T2D. Glycemic parameters were compared in 103 older adults (≥60 years) and 160 younger adults ( Disclosure T.Idrees: None. F.J.Pasquel: Consultant; AI Health LLC, Boehringer Ingelheim International GmbH, Dexcom, Inc., Research Support; Dexcom, Inc., Insulet Corporation, Merck & Co., Inc. L.Peng: None. G.E.Umpierrez: Research Support; AstraZeneca, Dexcom, Inc., Novo Nordisk. R.J.Galindo: Advisory Panel; Sanofi, WW International, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk. M.A.Urrutia: None. I.A.Castro-revoredo: None. E.Moreno: None. A.L.Migdal: None. G.Davis: Consultant; Medscape, Research Support; Insulet Corporation. P.Vellanki: n/a. M.Fayfman: None.

Inpatient use of CGM results in higher detection of hypoglycemic and hyperglycemic events compared to point of care testing (POC) but its efficacy and safety in adjusting insulin therapy has not been evaluated. This randomized controlled trial included 181 general medicine and surgery patients with type 1 (n= 18) and type 2 (n= 155) diabetes treated with a basal bolus insulin regimen. All patients underwent POC testing AC & HS. Patients in the POC group wore a blinded Dexcom G6 CGM with insulin dose adjusted based on POC results; while in the CGM group, insulin adjustment was based on daily Dexcom G6 CGM profile review. Hypoglycemia alarms were set at 80 mg/dl in the CGM group. Primary endpoints were differences in time in range (70-180 mg/dl) and hypoglycemia ( Results: There were no differences on admission clinical characteristics, HbA1c or diabetes type between POC and CGM groups. There were no differences in mean daily glucose (186.8±39 mg/dl vs. 183.2±40 mg/dl, p=0.36) , total daily insulin dose (36.1±28 U/day vs. 40.7±29 U/day, p=0.33) , % patients with CGM values Conclusion: Our results indicates that the inpatient use of Dexcom G6 CGM is safe and effective in guiding insulin adjustment resulting in similar improvement in glucose control and in significant reduction of recurrent hypoglycemic events compared to POC testing. Disclosure I. Spanakis: Other Relationship; Dexcom, Inc. L. G. Singh: None. C. Gothong: None. I. Marcano: None. S. Lizama: None. K. M. Munir: None. C. Chesney: None. R. D. Maguire: None. W. H. Scott: None. L. Peng: None. G. E. Umpierrez: Research Support; AstraZeneca, Dexcom, Inc., Novo Nordisk. M. A. Urrutia: None. M. F. Scioscia: None. R. J. Galindo: Advisory Panel; Sanofi, WW International, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk. P. Vellanki: n/a. A. L. Migdal: None. G. Davis: Consultant; Medscape, Research Support; Insulet Corporation. T. Idrees: None. F. J. Pasquel: Consultant; AI Health LLC, Boehringer Ingelheim International GmbH, Dexcom, Inc., Research Support; Dexcom, Inc., Insulet Corporation, Merck & Co., Inc.

AIM: To compare a glucagon-like peptide-1 receptor agonist with basal insulin at hospital discharge in patients with uncontrolled type 2 diabetes in a randomized clinical trial. METHODS: A total of 273 patients with glycated haemoglobin (HbA1c) 7%–10% (53–86 mol/mol) were randomized to liraglutide (n = 136) or insulin glargine (n = 137) at hospital discharge. The primary endpoint was difference in HbA1c at 12 and 26 weeks. Secondary endpoints included hypoglycaemia, changes in body weight, and achievement of HbA1c

Introduction Differences in biochemical parameters of diabetic ketoacidosis in patients with end-stage kidney disease (ESKD) has not been established. Accordingly, we assessed the relationship between degree of metabolic acidosis and ß-hydroxybutyrate in patients with ESKD (eGFR < 15 mL/min/1.73 m2), moderate renal failure (eGFR 15–60), or preserved renal function (eGFR > 60). Methods This observational study included adults (18–80 years) with diabetes ketoacidosis (DKA), admitted to Emory University Hospitals between January 1, 2006 to December 31, 2016. DKA and renal stages were confirmed on admission laboratory values. Results Admission bicarbonate levels (13.9 ± 5 vs 13.4 ± 5.3 vs 13.8 ± 4.2 mmol/L, P = 0.7), and pH levels (7.2 ± 0.3 vs 7.2 ± 0.2 vs 7.2 ± 0.2, P = 0.8) were similar among groups. Patients with ESKD had lower mean ß-hydroxybutyrate level (4.3 ± 3.3 vs 5.6 ± 2.9 vs 5.9 ± 2.5 mmol/L, P = 0.01), but higher admission glucose (852 ± 340.4 vs 714.6 ± 253.3 mg/dL vs 518 ± 185.7 mg/dL, P < 0.01), anion gap (23.4 ± 7.6 vs 23 ± 6.9 vs 19.5 ± 4.7 mmol/L, P < 0.01), and osmolality (306 ± 20.6 vs 303.5 ± vs 293.1 ± 3.1mOsm/kg, P < 0.01) compared with patients with moderate renal failure and preserved renal function, respectively. The sensitivity of ß-hydroxybutyrate > 3 mmol/L for diagnosing DKA by bicarbonate level < 15 and Conclusions Significant metabolic differences were found among DKA patients with different levels of renal function. In patients with ESKD, a ß-hydroxybutyrate level > 3 mmol/L may assist with confirmation of DKA diagnosis.

OBJECTIVE The use of remote real-time continuous glucose monitoring (CGM) in the hospital has rapidly emerged to preserve personal protective equipment and reduce potential exposures during coronavirus disease 2019 (COVID-19). RESEARCH DESIGN AND METHODS We linked a hybrid CGM and point-of-care (POC) glucose testing protocol to a computerized decision support system for continuous insulin infusion and integrated a validation system for sensor glucose values into the electronic health record. We report our proof-of-concept experience in a COVID-19 intensive care unit. RESULTS All nine patients required mechanical ventilation and corticosteroids. During the protocol, 75.7% of sensor values were within 20% of the reference POC glucose with an associated average reduction in POC of 63%. Mean time in range (70–180 mg/dL) was 71.4 ± 13.9%. Sensor accuracy was impacted by mechanical interferences in four patients. CONCLUSIONS A hybrid protocol integrating real-time CGM and POC is helpful for managing critically ill patients with COVID-19 requiring insulin infusion.

OBJECTIVE Diabetes and hyperglycemia are important risk factors for poor outcomes in hospitalized patients with coronavirus disease 2019 (COVID-19). We hypothesized that achieving glycemic control soon after admission, in both intensive care unit (ICU) and non-ICU settings, could affect outcomes in patients with COVID-19. RESEARCH DESIGN AND METHODS We analyzed pooled data from the Glytec national database including 1,544 patients with COVID-19 from 91 hospitals in 12 states. Patients were stratified according to achieved mean glucose category in mg/dL (≤7.77, 7.83–10, 10.1–13.88, and >13.88 mmol/L; ≤140, 141–180, 181–250, and >250 mg/dL) during days 2–3 in non-ICU patients or on day 2 in ICU patients. We conducted a survival analysis to determine the association between glucose category and hospital mortality. RESULTS Overall, 18.1% (279/1,544) of patients died in the hospital. In non-ICU patients, severe hyperglycemia (blood glucose [BG] >13.88 mmol/L [250 mg/dL]) on days 2–3 was independently associated with high mortality (adjusted hazard ratio [HR] 7.17; 95% CI 2.62–19.62) compared with patients with BG CONCLUSIONS Both hyperglycemia and hypoglycemia were associated with poor outcomes in patients with COVID-19. Admission glucose was a strong predictor of death among patients directly admitted to the ICU. Severe hyperglycemia after admission was a strong predictor of death among non-ICU patients.

Background Hyperglycaemia is associated with increased incidence of perioperative complications. We assessed whether treatment with sitagliptin, starting before surgery and continued during the hospital stay, can prevent and reduce the severity of perioperative hyperglycaemia in patients with type 2 diabetes undergoing coronary artery bypass graft (CABG) surgery. Martials and methods We conducted a double-blinded, placebo-control trial in adults with type 2 diabetes randomly assigned to receive sitagliptin or matching placebo starting one day prior to surgery and continued during the hospital stay. The primary outcome was difference in the proportion of patients with postoperative hyperglycaemia (blood glucose [BG] >10mmol/L [>180mg/dL]) in the intensive care unit (ICU). Secondary endpoints included differences in mean daily BG in the ICU and after transition to regular wards, hypoglycaemia, hospital complications, length of stay, and need of insulin therapy. Results We included 182 participants randomised to receive sitagliptin or placebo (91 per group, age 64±9 years, HbA1C: 7∙6±1∙5%, and diabetes duration: 10±9 years). There were no differences in number of patients with postoperative BG >10 mmol/L, mean daily BG in the ICU or after transition to regular floors, hypoglycaemia, hospital complications or length of stay. There were no differences on insulin requirements in the ICU; however, sitagliptin therapy was associated with lower mean daily insulin requirements (21∙1±18∙4 vs 32∙5±26∙3 units, p=0∙007) after transition to regular floor compared to placebo. Conclusion The administration of sitagliptin prior to surgery and during the hospital stay, did not prevent perioperative hyperglycaemia or complications after CABG. Sitagliptin therapy was associated with lower mean daily insulin requirements after transition to regular floors. This article is protected by copyright. All rights reserved.

OBJECTIVE We compared the performance of the FreeStyle Libre Pro continuous glucose monitoring (CGM) and point-of-care capillary glucose testing (POC) among insulin-treated hospitalized patients with type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS This was a prospective study in adult patients with T2D admitted to general medicine and surgery wards. Patients were monitored with POC before meals and bedtime and with CGM during the hospital stay. Study end points included differences between POC and CGM in mean daily blood glucose (BG), hypoglycemia RESULTS Mean daily glucose was significantly higher by POC (188.9 ± 37.3 vs. 176.1 ± 46.9 mg/dL) with an estimated mean difference of 12.8 mg/dL (95% CI 8.3–17.2 mg/dL), and proportions of patients with glucose readings CONCLUSIONS Compared with POC, FreeStyle Libre CGM showed lower mean daily glucose and higher detection of hypoglycemic events, particularly nocturnal and prolonged hypoglycemia in hospitalized patients with T2D. CGM’s accuracy was lower in the hypoglycemic range.

Background Adults with certain medical and behavioral factors are at increased risk for pneumococcal disease (PD). Sequential vaccination with 13-valent pneumococcal conjugate vaccine (PCV13) followed by 23-valent pneumococcal polysaccharide vaccine (PPSV23) is recommended for at-risk adults in some countries. Methods This phase 3 trial evaluated the safety, tolerability, and immunogenicity of sequential administration of either V114 (a 15-valent PCV containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F) or PCV13, followed 6 months later by PPSV23, in immunocompetent adults aged 18–49 years with or without predefined risk factors for PD (NCT03547167). Overall, 1515 participants were randomized 3:1 to receive either V114 or PCV13, followed by PPSV23. Results Most common solicited adverse events (AEs) following administration of V114 or PCV13 as well as PPSV23 were injection-site pain and fatigue. The proportion of participants with AEs was comparable in both groups. V114 and PCV13 were immunogenic based on opsonophagocytic activity (OPA) geometric mean titers (GMTs) 30 days postvaccination for all serotypes contained in each respective vaccine. OPA GMTs to the 2 unique serotypes in V114 were robust in the V114 group. PPSV23 was immunogenic for all 15 serotypes contained in V114 in both vaccination groups, including 22F and 33F. Conclusions V114 administered alone or sequentially with PPSV23 is well tolerated and immunogenic for all 15 serotypes, including those not contained in PCV13, in immunocompetent adults aged 18–49 years with or without certain medical or behavioral risk factors for PD. Clinical Trials Registration NCT03547167 and EudraCT 2017-004915-38.

OBJECTIVE Real-time continuous glucose monitoring (rtCGM) in critically ill hospitalized patients holds promise; however, real-world data are needed. RESEARCH DESIGN AND METHODS We placed Dexcom G6 CGM on intensive care unit (ICU) patients at Montefiore Medical Center with confirmed coronavirus disease 2019 (COVID-19) infection and glycemic variability. We analyzed inpatient CGM accuracy using point-of-care (POC) glucose–CGM matched pairs and included patients for analysis regardless of clinical status. RESULTS We included 11 patients with CGM: 8 on continuous insulin infusion (CII), 8 on vasopressors, 8 intubated, 4 on high-dose glucocorticoids, 6 on renal replacement therapy, and 2 with anasarca. Accuracy was 12.58% for mean and 6.3% for median absolute relative difference. CGM reduced POC testing by ∼60% for patients on CII. CONCLUSIONS In this real-world preliminary analysis of rtCGM during critical illness, we demonstrate early feasibility, considerable accuracy, and meaningful reduction in the frequency of POC glucose testing.

Remarkable advances in diabetes management have occurred since the discovery of insulin 100 years ago. Advances across a therapeutic spectrum, including pharmacotherapy, metabolic surgery, and diabetes technology, offer superior treatment options for diabetes management. New medication classes (glucagon-like peptide-1 receptor analogs and SGLT-2 inhibitors) have demonstrated cardiorenal benefits beyond glycemic control in type 2 diabetes mellitus, while evolving metabolic surgical interventions also help patients achieve diabetes remission. The use of artificial pancreas systems has shown consistent improvement in glycemic control in type 1 diabetes mellitus. It is time for policy changes to expand access to such advantageous therapies.

OBJECTIVE Administration of supplemental sliding scale insulin for correction of hyperglycemia in non–intensive care unit (ICU) patients with type 2 diabetes is frequently used with basal-bolus insulin regimens. In this noninferiority randomized controlled trial we tested whether glycemic control is similar with and without aggressive sliding scale insulin treatment before meals and bedtime in patients treated with basal-bolus insulin regimens. RESEARCH DESIGN AND METHODS Patients with type 2 diabetes with admission blood glucose (BG) 140–400 mg/dL treated with basal-bolus insulin were randomized to intensive (correction for BG >140 mg/dL, n = 108) or to nonintensive (correction for BG >260 mg/dL, n = 107) administration of rapid-acting sliding scale insulin before meals and bedtime. The groups received the same amount of sliding scale insulin for BG >260 mg/dL. Primary outcome was difference in mean daily BG levels between the groups during hospitalization. RESULTS Mean daily BG in the nonintensive group was noninferior to BG in the intensive group with equivalence margin of 18 mg/dL (intensive 172 ± 38 mg/dL vs. nonintensive 173 ± 43 mg/dL, P = 0.001 for noninferiority). There were no differences in the proportion of target BG readings of 70–180 mg/dL, 350 mg/dL (severe hyperglycemia) or total, basal, or prandial insulin doses. Significantly fewer subjects received sliding scale insulin in the nonintensive (n = 36 [34%]) compared with the intensive (n = 98 [91%] [P < 0.0001]) group with no differences in sliding scale insulin doses between the groups among those who received sliding scale insulin (intensive 7 ± 4 units/day vs. nonintensive 8 ± 4 units/day, P = 0.34). CONCLUSIONS Among non-ICU patients with type 2 diabetes on optimal basal-bolus insulin regimen with moderate hyperglycemia (BG

OBJECTIVE: Despite clinical guideline recommendations, sliding scale insulin (SSI) is widely used for the hospital management of patients with type 2 diabetes (T2D). We aimed to determine which patients with T2D can be appropriately managed with SSI in non–critical care settings. METHODS: We used electronic health records to assess inpatient glycemic control in medicine and surgical patients treated with SSI according to admission blood glucose (BG) concentration between June 2010 and June 2018. Primary outcome was the percentage of patients with T2D achieving target glycemic control, defined as mean hospital BG 70 to 180 mg/dL without hypoglycemia 250 mg/dL: OR, 7.2; 95% CI, 5.8-9.0), as compared with patients with BG

Complications of Coronavirus Disease 2019 (COVID-19) occur with increased frequency in people admitted to the hospital with diabetes or hyperglycemia. The increased risk for COVID-19 infections in the presence of these metabolic conditions is in part due to overlapping pathophysiologic features of COVID-19, diabetes, and glucose control. Various antiviral treatments are being tested in COVID-19 patients. We believe that in these trials, it will be useful to evaluate treatment effect differences in patients stratified according to whether they have diabetes or hyperglycemia. In this way, it will be possible to better facilitate development of antiviral treatments that are most specifically beneficial for the large subset of COVID-19 patients who have diabetes or hyperglycemia.

Introduction: During the COVID-19 pandemic, we implemented a protocol combining continuous glucose monitoring (CGM) with a computerized intravenous insulin infusion algorithm to care for patients with severe COVID-19. Objective: To examine glucose trends surrounding cardiac arrest events to evaluate the performance of CGM sensors during severe clinical instability. Methods: We reviewed eight cases of patients with type 2 diabetes diagnosed with COVID-19 requiring ICU care on IV insulin and CGM therapy experiencing severe clinical decompensation leading to cardiac arrest. Index events (cardiac arrest) were identified by staff documentation in the electronic health record. Clinical characteristics, mean arterial pressure (MAP), and point-of-care (POC) glucose values surrounding the index event were collected. CGM data was paired with MAP and POC glucose values. Rapid declines in the glucose trend [rate of change (ROC) ≥3mg/dl/min] were identified during this time of clinical instability. Results: The mean age of patients was 61.3±13.8 years. All patients were treated with steroid therapy, vasopressors, and mechanical ventilation. 62.5% were on CRRT. Four (50%) patients had sudden cardiac arrest and drop in MAP, while the other four patients had a more prolonged decline in MAP prior to cardiac arrest. CGM values in those with sudden arrest showed an abrupt decline (≥3mg/dl/min) an average of 16.7±13.7 min following cardiac arrest. Rapid down trending of CGM values in those with prolonged hypotension occurred on average about 6 hours prior to cardiac arrest. During these episodes, the CGM values stopped correlating with POC tests. Conclusions: Real-time CGM in critically-ill patients may provide clinical information beyond glucose control. Rapid declines in CGM values (≥3mg/dl/min) not correlating with POC glucose testing are associated with both sudden and prolonged changes in arterial pressure. Disclosure J. Hester: None. G. M. Davis: None. F. J. Pasquel: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Research Support; Self; Dexcom, Inc., Merck & Co., Inc. M. Rabinovich: None. N. Poindexter: None. S. Tekwani: None.

The efficacy of continuous glucose monitoring (CGM) after hospital discharge in patients with diabetes (DM) has not been established. This prospective pilot study compared glycemic outcomes between capillary blood glucose (CBG) and CGM after hospital discharge. At discharge, a blinded Dexcom G6 CGM was inserted in 82 patients with DM. Patients were asked to perform CBG testing (3-4/d) and to return the CBG logs and CGM device after 10 days of discharge. Patients were treated with insulin ± oral antidiabetic agents and followed by their primary care team. A total of 65 patients (73.3%) returned their CGM and were included (age 58.3±11 years, 56% Males, HbA1c 8.7±2%, 98% DM2). Only 42 patients (51.2%) returned CBG logs (mean 3.01±0.9 CBG/d). CGM detection of hypoglycemia Disclosure R. J. Galindo: Consultant; Self; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi US, Valeritas, Inc., Research Support; Self; Dexcom, Inc., Novo Nordisk. M. C. Perez-guzman: None. S. Cardona: None. F. J. Pasquel: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Research Support; Self; Dexcom, Inc., Merck & Co., Inc. L. Peng: None. G. E. Umpierrez: Research Support; Self; AstraZeneca, Dexcom, Inc., Novo Nordisk. G. Davis: None. T. Idrees: None. M. A. Urrutia: None. K. W. Zamudio: None. B. S. Albury: None. A. Migdal: None. P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. M. Fayfman: None. Funding Dexcom, Inc.

Limited data exist about the use of insulin degludec in the hospital. This prospective, open-label, randomized clinical trial compared the efficacy and safety of a basal-bolus regimen using degludec U100 or glargine U100 for the management of patients with T2D. A total of 181 general medicine and surgery patients (age: 56±11, diabetes duration: 13.0±9.2 years) with an admission BG: 140-400 mg/dL and treated with oral agents or insulin prior to admission were randomized to degludec (n=93) or glargine (n=88). Total daily insulin dose started at 0.4 U/kg/d for BG: 140-200 mg/dL or 0.5 U/kg/d for BG: 201-400 mg/dL half dose given as basal (degludec or glargine) once daily and half as prandial (aspart) before meals. Insulin was adjusted daily to a target BG before meals between 70-180 mg/dL. The primary outcome was a difference in mean daily BG during the hospital stay. For the entire cohort, the BG at randomization was 218.6±52 mg/dL and HbA1c: 9.79±2.0% [mean±SD]. There were no differences in mean daily BG (180.1±38 vs. 180.0±45 mg/dL, p=0.9), proportion of BG in target range of 70-180 mg/dL (54.5±29% vs. 55.3±28%, p=0.85), total daily insulin dose (56±24 vs. 59±36 units/day, p=0.92), basal insulin (29.6±13 vs. 30.4±18 units/day, p=0.85), length of stay (median (IQR): 6.7 (4.7-10.5) vs. 7.5 (4.7,11.6) days, p=0.61), hospital complications (23% vs. 23%, p=0.95), or treatment failures ([mean daily BG>240 mg/dL or >2 consecutive BG>240 mg/dL] 9.8% vs. 13%, p=0.62) between degludec and glargine. There were no differences in the proportion of patients with BG In summary, our study indicates that hospital treatment with degludec U100 or glargine U100 is equally effective and safe in improving glycemic control in general medicine and surgery patients with T2D. Disclosure R. J. Galindo: Consultant; Self; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi US, Valeritas, Inc., Research Support; Self; Dexcom, Inc., Novo Nordisk. S. Cardona: None. K. W. Zamudio: None. B. S. Albury: None. M. C. Perez-guzman: None. L. Peng: None. G. E. Umpierrez: Research Support; Self; AstraZeneca, Dexcom, Inc., Novo Nordisk. F. J. Pasquel: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Research Support; Self; Dexcom, Inc., Merck & Co., Inc. P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. R. Z. Alicic: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc. D. W. Lam: None. M. Fayfman: None. A. Migdal: None. M. A. Urrutia: None. G. Davis: None. Funding Novo Nordisk

This prospective observational study compared the performance of the Dexcom G6 continuous glucose monitor (CGM) and point-of-care (POC) blood glucose (BG) testing in a non-ICU setting. Methods: We placed a blinded Dexcom G6 on 91 insulin-treated adult medicine and surgery patients (age 57±10 years, BMI 35±10 kg/m2, HbA1c 9.2±2.1%), with a median hospital length of stay of 8.0 days (min, max 2.0, 33.0), and total daily insulin dose of 45±29 U/day, to compare inpatient glycemic control metrics as measured by POC and CGM. Results: CGM mean absolute relative difference (MARD) was 12.5% with 98.9% of glucose values falling into Clark Error Grid zone A or B for matched POC and CGM glucose pairs. Compared to POC, a greater percentage of patients were identified by CGM to have hypoglycemia 2 hours (5.6% vs. 0%) and severe hyperglycemia >250 mg/dl (73% vs. 66%). Differences in glycemic metrics between POC and CGM are shown in the Table. Conclusion: Dexcom G6 detected more overall, nocturnal and prolonged hypoglycemia in hospitalized non-ICU patients with diabetes than POC testing. Future prospective studies are needed to determine the benefits of real-time CGM in improving inpatient diabetes care and in reducing hypoglycemia and hyperglycemia in hospitalized patients with diabetes. Disclosure G. M. Davis: None. P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. F. J. Pasquel: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Research Support; Self; Dexcom, Inc., Merck & Co., Inc. L. Peng: None. G. E. Umpierrez: Research Support; Self; AstraZeneca, Dexcom, Inc., Novo Nordisk. A. Migdal: None. M. A. Urrutia: None. K. Zamudio-coronado: None. M. C. Perez-guzman: None. B. S. Albury: None. S. Cardona: None. R. J. Galindo: Consultant; Self; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk, Sanofi US, Valeritas, Inc., Research Support; Self; Dexcom, Inc., Novo Nordisk. T. Idrees: None. Funding Dexcom, Inc.

Diabetes is associated with poor clinical outcomes in hospitalized patients with coronavirus disease 2019 (COVID-19). During this pandemic, many hospitals have already become overwhelmed around the world and are rapidly entering crisis mode. While there are global efforts to boost personal protective equipment (PPE) production, many centers are improvising care strategies, including the implementation of technology to prevent healthcare workers’ exposures and reduce the waste of invaluable PPE. Not optimizing glycemic control due to clinical inertia driven by fear or lack of supplies may lead to poor outcomes in patients with diabetes and COVID-19. Individualized care strategies, novel therapeutic regimens, and the use of diabetes technology may reduce these barriers. However, systematic evaluation of these changes in care is necessary to evaluate both patient- and community-centered outcomes.

AIMS The use of incretin-based therapy, rather than or complementary to, insulin therapy is an active area of research in hospitalized patients with type 2 diabetes (T2D). We determined the glycaemic efficacy and safety of linagliptin compared to a basal-bolus insulin regimen in hospitalized surgical patients with T2D. MATERIALS AND METHODS This prospective open-label multicentre study randomized T2D patients undergoing non-cardiac surgery with admission blood glucose (BG) of 7.8 to 22.2 mmol/L who were under treatment with diet, oral agents or total insulin dose (TDD) ≤ 0.5 units/kg/day to either linagliptin (n = 128) daily or basal-bolus (n = 122) with glargine once daily and rapid-acting insulin before meals. Both groups received supplemental insulin for BG > 7.8 mmol/L. The primary endpoint was difference in mean daily BG between groups. RESULTS Mean daily BG was higher in the linagliptin group compared to the basal-bolus group (9.5 ± 2.6 vs 8.8 ± 2.3 mmol/L/dL, P = 0.03) with a mean daily BG difference of 0.6 mmol/L (95% confidence interval 0.04, 1.2). In patients with randomization BG < 11.1 mmol/L (63% of cohort), mean daily BG was similar in the linagliptin and basal-bolus groups (8.9 ± 2.3 vs 8.7 ± 2.3 mmol/L, P = 0.43); however, patients with BG ≥ 11.1 mmol/L who were treated with linagliptin had higher BG compared to the basal-bolus group (10.9 ± 2.6 vs 9.2 ± 2.2 mmol/L, P < 0.001). Linagliptin resulted in fewer hypoglycaemic events (1.6% vs 11%, P = 0.001; 86% relative risk reduction), with similar supplemental insulin and fewer daily insulin injections (2.0 ± 3.3 vs 3.1 ± 3.3, P < 0.001) compared to the basal-bolus group. CONCLUSIONS For patients with T2D undergoing non-cardiac surgery who presented with mild to moderate hyperglycaemia (BG < 11.1 mmol/L), daily linagliptin is a safe and effective alternative to multi-dose insulin therapy, resulting in similar glucose control with lower hypoglycaemia.

We present the case of multiple sclerosing pneumocytomas (SPs) associated with ACTH-secreting carcinoid tumorlets responsible for an ectopic Cushing syndrome (ECS). SP is a rare benign tumor originating from pulmonary epithelial cells. An 18-year-old male presented with shortness of breath and right-sided chest pain after exercise. Chest radiograph indicated right pneumothorax and bilateral lung nodules. CT imaging showed innumerable bilateral hypodense pulmonary nodules and a wedge resection gave the definitive diagnosis of SP with associated carcinoid tumorlets. Two years later, he presented with severe back pain in context of thoracic vertebral compression fracture. He had central fat accumulation, violaceous striae, proximal muscle weakness, hypertension, and diabetes. MRI of the pituitary gland showed a 7-mm adenoma. Inferior petrosal sinus sampling with no central-to-periphery gradient suggested an ectopic origin of ACTH, which was confirmed by ACTH expression in a subset of tumorlet cells in the lung lesions. The patient was started on ketoconazole and subsequently underwent a bilateral adrenalectomy. During follow-up, CT scans showed no growth of the lesions, except for the most recent CT scan, in which an increase in the size of the largest nodule was described. Ten years after the diagnosis, the patient remains asymptomatic of his pulmonary lesions. This article provides a case of ECS in the setting of multiple SP with associated carcinoid tumorlets.

Background Risk factors (RFs) for pneumococcal disease (PD) in immunocompetent individuals include comorbidities, behavioral habits, or living in a community with increased risk of PD transmission. RF stacking of comorbidities is associated with a higher incidence of PD, approaching that of immunocompromised individuals. Pneumococcal vaccination of certain adults is recommended with the 23-valent pneumococcal polysaccharide vaccine (PPSV23) alone/sequentially with pneumococcal conjugate vaccine (PCV). V114, an investigational 15-valent PCV, contains 2 epidemiologically important serotypes (STs), 22F and 33F, in addition to the 13 STs in 13-valent PCV (PCV13). Methods PNEU-DAY was a Phase 3 study evaluating V114 or PCV13 administered on Day 1, and PPSV23 given 6 months later, in adults aged 18–49 years with or without RFs. This subgroup analysis assessed safety, tolerability, and immunogenicity of V114 and PCV13 based on the number of baseline PD RFs, which included chronic liver, lung, and heart disease, diabetes mellitus, tobacco use, and alcohol consumption. Adverse events (AEs; overall and solicited) were collected after each vaccination. Immunogenicity assessment was based on ST-specific opsonophagocytic activity (OPA) at 30 days after each vaccination. Subgroup analyses were conducted by RF group (0, 1, or ≥2 RFs for PD). Results Among the 1515 participants randomized to V114 (n=1135) or PCV13 (n=380), 25.2% had no RFs, 54.7% had 1 RF and 20.1% had ≥2 RFs for PD at baseline. The proportions of participants with solicited AEs following V114/PCV13 and PPSV23 were comparable across the 3 subgroups, with injection-site pain, myalgia, and fatigue being the most common. V114 and PCV13 were immunogenic in all subgroups based on OPA geometric mean titers (GMTs) at 30 days post-vaccination for the 13 shared STs (Figure); in addition, V114 induced a robust immune response to the 2 unique STs (22F, 33F) in all subgroups. PPSV23 following PCV was immunogenic for all 15 STs contained in V114 across all subgroups. Figure. Serotype-specific OPA GMTs at baseline and 30 days post-vaccination with V114 and PCV13 by number of baseline risk factors (per-protocol population) Conclusion V114 administered alone/sequentially with PPSV23 is well tolerated and immunogenic for all 15 vaccine STs, including those not contained in PCV13, in immunocompetent adults aged 18–49 years, regardless of the number of baseline RFs. Disclosures Laura Hammitt, MD, MedImmune (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support)Merck & Co., Inc. (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support)Novavax (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support)Pfizer (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support) Francisco J. Pasquel, MD, MPH, Boehringer Ingelheim (Consultant)Dexcom (Grant/Research Support)Eli Lilly & Company (Consultant)Insulet (Grant/Research Support)Merck & Co., Inc. (Consultant, Grant/Research Support) K. Rajender Reddy, MD, BMS (Grant/Research Support)Deciphera (Advisor or Review Panel member)Gilead (Grant/Research Support)Grifols (Grant/Research Support)HCC-TARGET (Grant/Research Support)Intercept (Grant/Research Support)Mallinckrodt (Grant/Research Support, Advisor or Review Panel member)NASH-TARGET (Grant/Research Support)Pfizer (Advisor or Review Panel member)Sequana (Grant/Research Support) Ron Dagan, MD, Medimmune/AstraZeneca (Grant/Research Support, Scientific Research Study Investigator, Research Grant or Support)MSD (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker’s Bureau)Pfizer (Consultant, Grant/Research Support, Scientific Research Study Investigator, Advisor or Review Panel member, Research Grant or Support, Speaker’s Bureau) Rachel Dawson, D.O. MPH, Merck & Co., Inc. (Employee, Shareholder) Jennifer McCauley, BSc, Merck & Co., Inc. (Employee) Kyeongmi Cheon, Ph.D., Merck & Co., Inc. (Employee, Shareholder) Alison Pedley, PhD, Merck & Co., Inc. (Employee) Tina Sterling, BS, Merck & Co., Inc. (Employee, Shareholder) Gretchen Tamms, B.S., Merck Sharp and Dohme (Employee, Shareholder) Luwy Musey, MD, Merck & Co., Inc. (Employee) Ulrike K. Buchwald, MD, MS, Merck & Co., Inc. (Employee)TB Alliance (Employee)

Hyperglycaemia in people with and without diabetes admitted to the hospital is associated with a substantial increase in morbidity, mortality, and health-care costs. Professional societies have recommended insulin therapy as the cornerstone of inpatient pharmacological management. Intravenous insulin therapy is the treatment of choice in the critical care setting. In non-intensive care settings, several insulin protocols have been proposed to manage patients with hyperglycaemia; however, meta-analyses comparing different treatment regimens have not clearly endorsed the benefits of any particular strategy. Clinical guidelines recommend stopping oral antidiabetes drugs during hospitalisation; however, in some countries continuation of oral antidiabetes drugs is commonplace in some patients with type 2 diabetes admitted to hospital, and findings from clinical trials have suggested that non-insulin drugs, alone or in combination with basal insulin, can be used to achieve appropriate glycaemic control in selected populations. Advances in diabetes technology are revolutionising day-to-day diabetes care and work is ongoing to implement these technologies (ie, continuous glucose monitoring, automated insulin delivery) for inpatient care. Additionally, transformations in care have occurred during the COVID-19 pandemic, including the use of remote inpatient diabetes management-research is needed to assess the effects of such adaptations.