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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.

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.

Objective To evaluate the association between hyperglycemia treatment and mortality in patients with diabetes and COVID-19 in a Peruvian hospital. Methods A retrospective cohort study was conducted between March and July 2020. Individual-level data were extracted from an implemented virtual platform. We included patients with type 2 diabetes hospitalized with COVID-19. The assessed outcome was in-hospital mortality. The Independent variable of interest was hyperglycemic treatment. We used Poisson regressions with robust variance to obtain crude and adjusted relative risks (RR) and their 95% confidence intervals (95% CI). Results Out of 1635 patients hospitalized for COVID-19 during the study period, 248 patients with diabetes mellitus were included. The majority were men (66.9%), the median age was 62 years. Ninety-seven patients died in the hospital (39.1%). The median glycemia on admission was 222.5 mg/dL. At 48 h after hospital admission, 125 patients (50.4%) received sliding scale insulin alone (SSI), 46 (18.5%) received a fixed-dose insulin regimen. In the adjusted analysis, the group with SSI at 48 h of hospitalization had higher mortality than those with fixed-dose insulin (adjusted RR: 1.69; 95% CI: 1.01 – 2.83), and those and who continued with SSI in the following days had higher mortality compared to the group that switched to fixed-dose insulin (adjusted RR: 1.64; 95% CI: 1.17 – 2.32). Conclusion Among assessed patients with diabetes and COVID-19, more than a third died during hospitalization. Early and continuous use of the sliding scale was associated with higher mortality compared to fixed-dose insulin regimens.

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: 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

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.

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.

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.

Sodium-glucose cotransporter 2 (SGLT-2) inhibitors are cardiorenal protective agents increasingly used in patients with diabetes. Cases of euglycemic diabetic ketoacidosis (euDKA) have been reported particularly among patients with type 1 diabetes. Our case is an example that highlights the role SGLT-2 inhibitors play in the development of euDKA in a patient with type 2 diabetes with confounding factors of strict adherence to a ketogenic diet and ankle fracture. A 72-year-old female with a history of type 2 diabetes presented to the emergency department (ED) with right ankle pain and obvious deformity after a mechanical fall. Radiography of the right lower extremity confirmed distal fracture of the tibia and fibula. After reduction of her fracture in the ED, she was admitted in anticipation of an open reduction internal fixation. Her diabetes was controlled on empagliflozin monotherapy and adhering to a ketogenic diet. She monitored her blood ketones daily at home and reported values in the 3–4 mmol/L range. On admission, her basic metabolic panel (BMP) revealed a blood glucose of 148 mg/dL, bicarbonate of 20 mEq/L, anion gap of 18 mEq/L, Cr of 1.3 mg/dl, and eGFR of 40 mL/min. Her beta-hydroxybutyrate (BHB) was 5.09 mmol/L. The initial assessment was presumed starvation ketosis. On hospital day three, she complained of continued nausea, polydipsia, and abdominal pain. Chart review revealed nocturia with approximately 3–4 voids per night. Repeat BMP showed a blood glucose of 152 mg/dL, bicarbonate of 16 mEq/L, anion gap still at 18 mEq/L, Cr 1.4 mg/dl, and eGFR of 37 mL/min. Since admission, all of her blood glucose levels ranged between 118–178 mg/dL. She denied dyspnea but exhibited Kussmaul respirations on physical exam. Repeat labs revealed a BHB of 8.92 mmol/L, and arterial blood gas (ABG) showed pH 7.2, pCO2 23, pO2 100, bicarbonate 8.6 mEq/L, consistent with high-anion gap metabolic acidosis, confirming the diagnosis of euDKA. Her empagliflozin had been held since admission, but she had not received any insulin up to this point due to euglycemia. She was immediately started on a weight-based dose of 12 units of insulin glargine with subsequent improvement of her BHB and anion gap. This patient’s use of an SGLT2-inhibitor in combination with her being on a ketogenic diet, contributed to a nonregulated state of ketone production leading to euDKA in the perioperative period. As SGLT2-inhibitors become more readily available, it is important to educate physicians and patients about the risk of euDKA during fasting, ketogenic diets, and the perioperative period.

Rapid implementation of remote continuous glucose monitoring (CGM) is occurring across hospitals during the coronavirus disease 2019 (COVID-19) pandemic. Despite limited experience, the U.S. Food and Drug Administration is not objecting to the inpatient use of CGM to limit the exposure of health care workers to severe acute respiratory syndrome coronavirus 2 and to reduce the waste of personal protective equipment (1). Recent efforts in non–intensive care unit (ICU) patients suggest that CGM devices are accurate in the inpatient setting and can help monitor patients remotely (2,3). In addition, two recent small trials enrolling non-ICU patients confirm the feasibility of using remote real-time CGM in the hospital (4,5). The accuracy of sensors, however, may be affected during various conditions that have not been well studied (i.e., MRI, surgery, shock requiring vasopressor therapy, hypoxia) (1). To mitigate potential CGM inaccuracy, a hybrid approach using real-time CGM with periodic point-of-care (POC) validation has been suggested (1). We report here on the likely loss of sensor signal during cardiac surgery and potential loss of accuracy in the operating room (OR). We also report on the accuracy of sensors that recovered immediately after surgery during critical illness. We evaluated the performance of sensors in adults without diabetes undergoing scheduled or urgent coronary artery bypass surgery (CABG). We excluded …

The COVID-19 pandemic is considered a mass casualty incident of the most severe nature leading to unearthed uncertainties around management, prevention, and care. As of July 2020, more than twelve million people have tested positive for COVID-19 globally and more than 500 000 people have died. Patients with diabetes are among the most severely affected during this pandemic. Healthcare systems have made emergent changes to adapt to this public health crisis, including changes in diabetes care. Adaptations in diabetes care in the hospital (ie, changes in treatment protocols according to clinical status, diabetes technology implementation) and outpatient setting (telemedicine, mail delivery, patient education, risk stratification, monitoring) have been improvised to address this challenge. We describe how to respond to the current public health crisis focused on diabetes care in the USA. We present strategies to address and evaluate transitions in diabetes care occurring in the immediate short-term (ie, response and mitigation), as well as phases to adapt and enhance diabetes care during the months and years to come while also preparing for future pandemics (ie, recovery, surveillance, and preparedness). Implementing multidimensional frameworks may help identify gaps in care, alleviate initial demands, mitigate potential harms, and improve implementation strategies and outcomes in the future.

Diabetes is one of the world's fastest growing health challenges. Insulin therapy remains a useful regimen for many elderly patients, such as those with moderate to severe hyperglycemia, type 1 diabetes, hyperglycemic emergencies, and those who fail to maintain glucose control on non-insulin agents alone. Recent clinical trials have shown that several non-insulin agents as monotherapy, or in combination with low doses of basal insulin, have comparable efficacy and potential safety advantages to complex insulin therapy regimens. Determining the most appropriate diabetes management plan for older hospitalized patients requires consideration of many factors to prevent poor outcomes related to dysglycemia.

Continuous glucose monitoring (CGM) has become a widely used tool in the ambulatory setting for monitoring glucose levels, as well as detecting uncontrolled hyperglycemia, hypoglycemia, and glycemic variability. The accuracy of some CGM systems has recently improved to the point of manufacture with factory calibration and Food and Drug Administration clearance for nonadjunctive use to dose insulin. In this commentary, we analyze the answers to six questions about what is needed to bring CGM into the hospital as a reliable, safe, and effective tool. The evidence to date indicates that CGM offers promise as an effective tool for monitoring hospitalized patients. During the current coronavirus disease 2019 crisis, we hope to provide guidance to healthcare professionals, who are seeking to reduce exposure to SARS-Cov-2, as well as preserve invaluable personal protective equipment. In this commentary, we address who, what, where, when, why, and how CGM can be adopted for inpatient use.

Sliding scale insulin (SSI) continues to be widely used for glycemic management of inpatients with T2D despite condemnation in clinical guidelines. To confirm the accuracy of this clinical guideline recommendation, we determined the efficacy and safety of using SSI for the management hyperglycemia of non-critical patients with T2D in a large multinational, propensity-matched cohort study. A total of 53,516 patients with ICD 9/10 code of T2D were included in the dataset. Patients were categorized as having received SSI only vs. basal insulin, and were matched according to age, BMI, Charlson Comorbidity Index, and admission blood glucose (BG). Among patients with admission BG Conclusion: In a multicenter, international, propensity-matched cohort study, 69% of patients with T2D with admission BG Disclosure A. Migdal: None. C. Fortin: None. Y. Guo: None. I. Hochberg: None. M.F. Magee: Consultant; Self; Mytonomy. Employee; Spouse/Partner; U.S. Food and Drug Administration. Research Support; Self; AstraZeneca, Eli Lilly and Company, National Institute of Diabetes and Digestive and Kidney Diseases. Speaker’s Bureau; Self; American Diabetes Association, Pri-Med LLC. Other Relationship; Self; Endocrine Society. F.J. Pasquel: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Research Support; Self; Dexcom, Inc., Merck Sharp & Dohme Corp., National Institutes of Health. G.E. Umpierrez: None. Funding Jacobs Research Foundation

The administration of rapid-acting insulin per sliding scale (SSI) for correction of hyperglycemia in non-ICU patients with type 2 diabetes (T2D) is used with most basal-bolus insulin (BBI) regimens; however, the safety and efficacy of using SSI has not been tested in RCTs. In this non-inferiority RCT, we tested whether correction of hyperglycemia before meals and bedtime improves glycemic control in patients treated with BBI regimens. Patients with T2D with a blood glucose (BG) > 140 mg/dl treated with BBI were randomized to SSI for BG >140 mg/dl (intensive supplement) or to SSI for BG >260 mg/dl (non-intensive supplement). Primary outcome was difference in mean BG levels between the groups during hospital stay. There were no differences in baseline characteristics between the intensive and non-intensive supplement groups. There were no differences between groups in mean daily BG, length of stay (LOS), hypoglycemia (BG < 70 or < 54 mg/dl), severe hyperglycemia (BG > 350 mg/dl), and total, basal, prandial or supplemental daily insulin doses (U/day). In patients with any BG 140-260 mg/dl and without BG > 260 mg/dl, mean BG did not differ but non-intensive group needed more prandial insulin. Conclusion: Adding correction/supplement SSI in non-ICU T2D patients with mild to moderate hyperglycemia ( Disclosure P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. S. Cardona: None. M.A. Urrutia: None. R.J. Galindo: Advisory Panel; Self; Lilly Diabetes. Consultant; Self; Valeritas, Inc. Research Support; Self; Novo Nordisk Inc. Other Relationship; Self; UpToDate. G. Davis: None. J. Haw: None. M. Fayfman: None. A. Migdal: None. Y. Guo: None. F.J. Pasquel: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Research Support; Self; Dexcom, Inc., Merck Sharp & Dohme Corp., National Institutes of Health. G.E. Umpierrez: None. Funding National Institutes of Health

Insulin pen devices have been reported to improve patient satisfaction and treatment adherence compared to the traditional vial/syringe. Insulclock® is a small electronic device plugged onto insulin pen to track information via Bluetooth to smart-phone technology on date, time and dosage of injections and with an alarm system to reduce insulin omissions. We performed a randomized, cross-over design study in patients with type 2 diabetes (T2D) on basal insulin to assess the efficacy and satisfaction of Insulclock device. Eighty T2D patients on basal insulin ± oral agents with HbA1c between 7.0% and 12.0% were randomized to a 12-week ’intervention’ phase receiving reminders or to a 12-week ’control’ phase with device without feedback. Basal insulin was titrated every 2 weeks to a target fasting and premeal glucose between 70-130 mg/dl. Study outcomes included differences between groups on glycemic control, treatment adherence and satisfaction (DTSQc survey). Baseline characteristics were similar between groups (56±11 years, HbA1c 9.2%±1.5). HbA1c improved significantly from baseline, with reduction of 0.9 % in the intervention and 0.7% in the control group. Insulclock improved glycemic control with an estimated reduction in average mean daily blood glucose (BG), fasting BG, and pre-meal BG of 6.03 (95% CI: [-3.21, 15.3]), 6.66 (95% CI: [-1.72, 15.04]), and 5.57 (95% CI: [-6.15, 17.31]) mg/dl, respectively. Repeated measures analyses based on linear mixed models suggest significant effects of insulclock on the trajectory of mean daily BG, fasting BG, pre-meal BG (p In conclusion, the use of Insulclock resulted in improved glycemic control and treatment satisfaction in insulin treated patients with T2D. Disclosure C. Ramos: None. R.J. Galindo: Advisory Panel; Self; Lilly Diabetes. Consultant; Self; Valeritas, Inc. Research Support; Self; Novo Nordisk Inc. Other Relationship; Self; UpToDate. M.M. Alam: None. S. Cardona: None. B.S. Albury: None. O. Oladejo: None. F.J. Pasquel: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Research Support; Self; Dexcom, Inc., Merck Sharp & Dohme Corp., National Institutes of Health. P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. M. Fayfman: None. A. Migdal: None. G. Davis: None. J. Haw: None. G.E. Umpierrez: None.

Background: There is increasing interest in using CGM for the inpatient management of diabetes in non-ICU settings. Current industry guidelines recommend removing devices when undergoing certain radiology procedures due to concerns about potential interference with CGM system functioning. However, there is no published data on the impact of CGM precision and accuracy after radiation and contrast exposure to support this recommendation. Methods: We collected data on 49 adult medicine and surgery patients with type 1 and type 2 diabetes who were monitored with Dexcom CGM systems before and after radiology procedures (x-rays, CT scan, catheterization/angiography). The primary outcome was glycemic variability by percent coefficient of variation (%CV) as reported by CGM 2-hours pre and post imaging. Secondary outcome was the mean absolute relative difference (MARD) between matched glucose pairs from capillary point-of-care and CGM pre and post imaging procedure. Results: There were no significant differences in mean blood glucose (BG) or %CV seen on CGM readings for all imaging procedures combined (delta mean BG -7.7 ±26.0, p=0.051; %CV 18.0% pre vs. 19.1% post, p=0.65) or when stratified by x-ray (delta mean BG -8.8 ±29.9, p=0.15; %CV 20.1% pre vs. 21.5% post, p=0.60) vs. CT scan/catheterization/angiography (delta mean BG -6.3 ±20.6, p=0.19; %CV 15.2% pre vs. 15.9% post, p=0.97). The overall MARD was 13.3% pre-imaging and 12.7% post-imaging. The overall percentage of glucose values within ±15%/15mg/dl, ±20%/20mg/dl, and ±30%/30mg/dl of the POC reference value was 69%, 80%, and 94%, respectively pre-imaging, and 69%, 82% and 93% post-imaging (p=NS). Clarke Error Grid analysis showed 98.1% of glucoses falling into Zones A and B pre-imaging and 99.7% post-imaging. Conclusions: Preliminary data suggests that ongoing CGM usage during multiple radiology procedures is safe and reliable without interference or disruption in CGM data transmission. Disclosure A. Migdal: None. E. Spanakis: Research Support; Self; Dexcom, Inc. R.J. Galindo: Advisory Panel; Self; Lilly Diabetes. Consultant; Self; Valeritas, Inc. Research Support; Self; Novo Nordisk Inc. Other Relationship; Self; UpToDate. G. Davis: None. L.G. Singh: None. M. Satyarengga: None. M. Fayfman: None. F.J. Pasquel: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Research Support; Self; Dexcom, Inc., Merck Sharp & Dohme Corp., National Institutes of Health. B.S. Albury: None. M.A. Urrutia: None. K.W. Zamudio: None. S. Gibanica: None. S. Cardona: None. L. Peng: None. G.E. Umpierrez: None. Funding Dexcom, Inc.

Glycated hemoglobin (HbA1c) on admission has been suggested as a predictor of glycemic control in the hospital. However, no studies have examined the interaction of pre-admission patient characteristics (i.e., complexity of home regimen or diabetes duration) and HbA1c on inpatient glycemic control. We pooled data from eight randomized controlled trials of patients assigned to a standardized basal-bolus insulin regimen in the hospital. Patients were categorized according to: A) increasing home regimen complexity [group 1: diet alone or ≤1 oral antihyperglycemic drugs (OADs) (n=338, 39%); group 2: two or more OADs (n=177, 20%); and group 3: insulin based regimens (n=356, 41%) and B) admission HbA1c categories (9%). Logistic regression models adjusting for age, gender, BMI, admission BG, and hospital service (medicine vs. surgery) were constructed to determine associations between home regimen complexity, diabetes duration, HbA1c and inpatient glycemic control. Compared to patients treated at home with OADs, patients using insulin had a longer duration of diabetes and higher admission HbA1c (both p9% aOR 0.44 (0.24, 0.83), and had higher risk for hypoglycemia (all p10 years) were less likely to achieve good glycemic control compared to patients with shorter duration of diabetes irrespective of home regimen complexity. Though admission HbA1c has been proposed as a predictor of inpatient glycemic control, our data show patients requiring complex therapy with insulin at home are less likely to achieve inpatient glucose targets independent of admission HbA1c. Disclosure M.A. Urrutia: None. Y. Guo: None. M. Fayfman: None. P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. R.J. Galindo: Advisory Panel; Self; Lilly Diabetes. Consultant; Self; Valeritas, Inc. Research Support; Self; Novo Nordisk Inc. Other Relationship; Self; UpToDate. A. Migdal: None. G. Davis: None. I. Anzola: None. B.S. Albury: None. M.F. Scioscia: None. K.W. Zamudio: None. G.E. Umpierrez: None. F.J. Pasquel: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Research Support; Self; Dexcom, Inc., Merck Sharp & Dohme Corp., National Institutes of Health.

Limited studies have compared diabetes treatment regimens during the transition from the inpatient to outpatient setting. This RCT compared the safety and efficacy of liraglutide with glargine U100 in general medicine and surgery patients with T2D at hospital discharge. A total of 227 patients with HbA1c 7-10%, treated at home with diet, oral agents, or insulin at a total daily dose ≤0.4 units/kg were randomized to liraglutide (1.8mg/day) or glargine. The primary efficacy endpoint was difference in HbA1c at 12 and 26 weeks. Secondary endpoints included changes in weight, postprandial glucose, hypoglycemia, achievement of HbA1c In summary, the use of liraglutide after hospital discharge is associated with similar change in HbA1c compared to glargine. Liraglutide treatment resulted in less hypoglycemia, greater weight reduction, with expected increased gastrointestinal adverse events. Disclosure F.J. Pasquel: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Research Support; Self; Dexcom, Inc., Merck Sharp & Dohme Corp., National Institutes of Health. M.A. Urrutia: None. S. Cardona: None. G. Iacobellis: None. J. Farias: None. A. Chaudhuri: Consultant; Self; Bayer U.S. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk Inc., Sanofi US. I. Anzola: None. J.D. Palacios: None. B.S. Albury: None. P.C. Gomez: None. K.W. Zamudio: None. M.C. Perez-Guzman: None. P. Vellanki: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc. M. Fayfman: None. J. Haw: None. R.J. Galindo: Advisory Panel; Self; Lilly Diabetes. Consultant; Self; Valeritas, Inc. Research Support; Self; Novo Nordisk Inc. Other Relationship; Self; UpToDate. G. Davis: None. A. Migdal: None. L. Peng: None. G.E. Umpierrez: None. Funding Novo Nordisk

Professional guidelines recommend insulin therapy for treatment of type 2 diabetes (T2D) in the hospital. However, oral antidiabetes drugs (OAD) are commonly used despite the lack of safety and efficacy data. We analyzed individual level data from non-critically ill patients with T2D admitted to three large healthcare systems between 2008-2018 (N=187,396). We conducted propensity score matching analyses to determine the relative efficacy and safety of OAD. Patients were treated with basal insulin (20%), sliding scale insulin alone (28%), basal insulin with OADs (23%), metformin (21%), sulfonylureas (11%), or DPP-4 inhibitors (4%). Less than 1% were treated with thiazolidinediones or SGLT2 inhibitors. Patients started on basal insulin had more comorbidities and had higher glucose levels on admission. After matching for age, BMI, Charlson Comorbidity Index, and admission blood glucose, exposure to OADs, with or without basal insulin, was associated with non-clinically meaningful differences in glycemic control compared to basal insulin use alone (183.1± 53.8 vs. 175.7± 53.9 vs. 180.3± 54.9, p In summary, the use of OADs with or without basal insulin is associated with acceptable glycemic control compared to insulin therapy. Basal insulin use and the use of sulfonylureas is associated with a high incidence of hypoglycemia. Disclosure F.J. Pasquel: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp. Research Support; Self; Dexcom, Inc., Merck Sharp & Dohme Corp., National Institutes of Health. M.F. Magee: Consultant; Self; Mytonomy. Employee; Spouse/Partner; U.S. Food and Drug Administration. Research Support; Self; AstraZeneca, Eli Lilly and Company, National Institute of Diabetes and Digestive and Kidney Diseases. Speaker’s Bureau; Self; American Diabetes Association, Pri-Med LLC. Other Relationship; Self; Endocrine Society. I. Hochberg: None. C. Fortin: None. A. Migdal: None. S. Cardona: None. M. Fayfman: None. Y. Guo: None. L. Peng: None. G.E. Umpierrez: None. Funding Jacobs Family Funds

DPP-4 inhibitors (DPP-4i) have been shown to be effective for the management of inpatient diabetes. We report pooled data from 3 prospective studies using DPP-4i in general medicine and surgery patients with type 2 diabetes (T2D).We combined data from 3 randomized studies comparing DPP-4i alone or in combination with basal insulin or a basal-bolus insulin regimen. Medicine (n = 266) and surgery (n = 319) patients admitted with a blood glucose (BG) between 140 and 400 mg/dL, treated with diet, oral agents, or low-dose insulin therapy were included. Patients received DPP-4i alone (n = 144), DPP-4i plus basal insulin (n = 158) or basal-bolus regimen (n = 283). All groups received correctional doses with rapid-acting insulin for BG140 mg/dL. The primary endpoint was differences in mean daily BG between groups. Secondary endpoints included differences in hypoglycemia and hospital complications.There were no differences in mean hospital daily BG among patients treated with DPP-4i alone (170 ± 37 mg/dL), DPP-4i plus basal (172 ± 42 mg/dL), or basalbolus (172 ± 43 mg/dL), P = .94; or in the percentage of BG readings within target of 70 to 180 mg/dL (63 ± 32%, 60 ± 31%, and 64 ± 28%, respectively; P = .42). There were no differences in length of stay or complications, but hypoglycemia was less common with DPP-4i alone (2%) compared to DPP-4i plus basal (9%) and basal-bolus (10%); P = .004.Treatment with DPP-4i alone or in combination with basal insulin is effective and results in a lower incidence of hypoglycemia compared to a basal-bolus insulin regimen in general medicine and surgery patients with T2D.BG = blood glucose; BMI = body mass index; CI = confidence interval; DPP-4i = dipeptidyl peptidase-4 inhibitors; HbA1c = hemoglobin A1c; OR = odds ratio; T2D = type 2 diabetes.

OBJECTIVE The role of U300 glargine insulin for the inpatient management of type 2 diabetes (T2D) has not been determined. We compared the safety and efficacy of glargine U300 versus glargine U100 in noncritically ill patients with T2D. RESEARCH DESIGN AND METHODS This prospective, open-label, randomized clinical trial included 176 patients with poorly controlled T2D (admission blood glucose [BG] 228 ± 82 mg/dL and HbA1c 9.5 ± 2.2%), treated with oral agents or insulin before admission. Patients were treated with a basal-bolus regimen with glargine U300 (n = 92) or glargine U100 (n = 84) and glulisine before meals. We adjusted insulin daily to a target BG of 70–180 mg/dL. The primary end point was noninferiority in the mean difference in daily BG between groups. The major safety outcome was the occurrence of hypoglycemia. RESULTS There were no differences between glargine U300 and U100 in mean daily BG (186 ± 40 vs. 184 ± 46 mg/dL, P = 0.62), percentage of readings within target BG of 70–180 mg/dL (50 ± 27% vs. 55 ± 29%, P = 0.3), length of stay (median [IQR] 6.0 [4.0, 8.0] vs. 4.0 [3.0, 7.0] days, P = 0.06), hospital complications (6.5% vs. 11%, P = 0.42), or insulin total daily dose (0.43 ± 0.21 vs. 0.42 ± 0.20 units/kg/day, P = 0.74). There were no differences in the proportion of patients with BG 0.99), but glargine U300 resulted in significantly lower rates of clinically significant hypoglycemia ( CONCLUSIONS Hospital treatment with glargine U300 resulted in similar glycemic control compared with glargine U100 and may be associated with a lower incidence of clinically significant hypoglycemia.

OBJECTIVE To report U.S. national population-based rates and trends in diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar state (HHS) among adults, in both the emergency department (ED) and inpatient settings. RESEARCH DESIGN AND METHODS We analyzed data from 1 January 2006 through 30 September 2015 from the Nationwide Emergency Department Sample and National Inpatient Sample to characterize ED visits and inpatient admissions with DKA and HHS. We used corresponding year cross-sectional survey data from the National Health Interview Survey to estimate the number of adults ≥18 years with diagnosed diabetes to calculate population-based rates for DKA and HHS in both ED and inpatient settings. Linear trends from 2009 to 2015 were assessed using Joinpoint software. RESULTS In 2014, there were a total of 184,255 and 27,532 events for DKA and HHS, respectively. The majority of DKA events occurred in young adults aged 18–44 years (61.7%) and in adults with type 1 diabetes (70.6%), while HHS events were more prominent in middle-aged adults 45–64 years (47.5%) and in adults with type 2 diabetes (88.1%). Approximately 40% of the hyperglycemic events were in lower-income populations. Overall, event rates for DKA significantly increased from 2009 to 2015 in both ED (annual percentage change [APC] 13.5%) and inpatient settings (APC 8.3%). A similar trend was seen for HHS (APC 16.5% in ED and 6.3% in inpatient). The increase was in all age-groups and in both men and women. CONCLUSIONS Causes of increased rates of hyperglycemic events are unknown. More detailed data are needed to investigate the etiology and determine prevention strategies.

OBJECTIVE Many patients with hyperglycemic crises present with combined features of diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS). The implications of concomitant acidosis and hyperosmolality are not well known. We investigated hospital outcomes in patients with isolated or combined hyperglycemic crises. RESEARCH DESIGN AND METHODS We analyzed admissions data listing DKA or HHS at two academic hospitals. We determined 1) the frequency distributions of HHS, DKA, and combined DKA-HHS (DKA criteria plus elevated effective osmolality); 2) the relationship of markers of severity of illness and clinical comorbidities with 30-day all-cause mortality; and 3) the relationship of hospital complications associated with insulin therapy (hypoglycemia and hypokalemia) with mortality. RESULTS There were 1,211 patients who had a first admission with confirmed hyperglycemic crises criteria, 465 (38%) who had isolated DKA, 421 (35%) who had isolated HHS, and 325 (27%) who had combined features of DKA-HHS. After adjustment for age, sex, BMI, race, and Charlson Comorbidity Index score, subjects with combined DKA-HHS had higher in-hospital mortality compared with subjects with isolated hyperglycemic crises (adjusted odds ratio [aOR] 2.7; 95% CI 1.4, 4.9; P = 0.0019). In all groups, hypoglycemia ( CONCLUSIONS Combined DKA-HHS is associated with higher mortality compared with isolated DKA or HHS. Severe hypokalemia and severe hypoglycemia are associated with higher hospital mortality in patients with hyperglycemic crises.

AIMS: Differences in risk profiles for individuals with early- (< 40 years old) vs. later-onset (≥ 40 years old) diabetes were examined. METHODS: A nested case-control study design using 30-year longitudinal data from the Coronary Artery Risk Development in Young Adults (CARDIA) study was used. Survey data (socio-demographics, family history, medical records, and lifestyle behaviors), obesity-related measures (body mass index, weight), blood pressure, and laboratory data (insulin, fasting glucose, 2-h glucose, and lipids) were used to examine progression patterns of diabetes development in those with early-onset vs. later-onset diabetes. RESULTS: Of 605 participants, 120 were in early-onset group while 485 were in later-onset group. Early-onset group had a lower A Priori Diet Quality Score, but not statistically significant at baseline; however, the between-group difference became significant at the time that diabetes was first detected (p=.026). The physical activity intensity score consistently decreased from baseline to the development of diabetes in both the early- and later-onset groups. Early-onset group showed more dyslipidemia at baseline and at the time that diabetes was first detected, and rapid weight gain from baseline to the development of diabetes. CONCLUSIONS: Emphases on lifestyle modification and risk-based diabetes screening in asymptomatic young adults are necessary for early detection and prevention.

Diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar state (HHS) are the most serious and life-threatening hyperglycemic emergencies in diabetes. DKA is more common in young people with type 1 diabetes and HHS in adult and elderly patients with type 2 diabetes. Features of the 2 disorders with ketoacidosis and hyperosmolality may coexist. Both are characterized by insulinopenia and severe hyperglycemia. Early diagnosis and management are paramount. Treatment is aggressive rehydration, insulin therapy, electrolyte replacement, and treatment of underlying precipitating events. This article reviews the epidemiology, pathogenesis, diagnosis, and management of hyperglycemic emergencies.

Aims Hyperglycaemic crises (diabetic ketoacidosis and hyperosmolar hyperglycaemic state) are medical emergencies in people with diabetes. We aimed to determine their incidence, recurrence and economic impact. Methods An observational study of hyperglycaemic crises cases using the database maintained by the out-of-hospital emergency service, the Healthcare Emergency Public Service (EPES) during 2012. The EPES provides emergency medical services to the total population of Andalusia, Spain (8.5 million inhabitants) and records data on the incidence, resource utilization and cost of out-of-hospital medical care. Direct costs were estimated using public prices for health services updated to 2012. Results Among 1 137 738 emergency calls requesting medical assistance, 3157 were diagnosed with hyperglycaemic crises by an emergency coordinator, representing 2.9 cases per 1000 persons with diabetes [95% confidence intervals (CI) 2.8 to 3.0]. The incidence of diabetic ketoacidosis was 2.5 cases per 1000 persons with diabetes (95% CI 2.4 to 2.6) and the incidence of hyperosmolar hyperglycaemic state was 0.4 cases per 1000 persons with diabetes (95% CI 0.4 to 0.5). In total, 17.7% (n = 440) of people had one or more hyperglycaemic crisis. The estimated total direct cost was €4 662 151, with a mean direct cost per episode of €1476.8 ± 217.8. Conclusions Hyperglycaemic crises require high resource utilization of emergency medical services and have a significant economic impact on the health system. This article is protected by copyright. All rights reserved.

The financial impact of intensive (blood glucose [BG] 100-140mg/dl [5.5-7.8mM] vs. conservative (141-180mg/dl (7.9-10.0mM) glucose control in the ICU in patients, with and without diabetes, undergoing coronary artery bypass graft (CABG) surgery is not known.This post-hoc cost analysis determined differences in hospitalization costs, resource utilization and perioperative complications in 288 CABG patients with diabetes (n=143) and without diabetes (n=145), randomized to intensive (n=143) and conservative (n=145) glucose control.Intensive glucose control resulted in lower BG (131.4±14mg/dl-(7.2±0.8mM) vs. 151.6±17mg/dl (8.4±0.8mM, p0.001), a nonsignificant reduction in the median length of stay (LOS, 7.9 vs. 8.5days, p=0.17) and in a composite of perioperative complications including wound infection, bacteremia, acute renal and respiratory failure, major cardiovascular events (42% vs 52%, p=0.10) compared to conservative control. Median hospitalization costs were lower in the intensive group ($39,366 vs. $42,141, p=0.040), with a total cost savings of $3654 (95% CI: $1780-$3723), than conservative control. Resource utilization for radiology (p=0.008), laboratory (p=0.014), consultation service (p=0.013), and ICU utilization (p=0.007) were also lower in the intensive group. Compared to patients without perioperative complications, those with complications had longer hospital length of stay (10.7days vs. 6.7days, p0.001), higher total hospitalization cost ($48,299 vs. $32,675, p0.001), and higher resource utilization units (2745 vs. 1710, p0.001).Intensive glycemic control [BG 100-140mg/dl (5.5-7.8mM)] in patients undergoing CABG resulted in significant reductions in hospitalization costs and resource utilization compared to patients treated with conservative [BG 141-180mg/dl (7.9-10.0mM)] glucose control.

The role of incretin-based drugs in the treatment of patients with type 2 diabetes admitted to hospital has not been extensively assessed. In this study, we compared the safety and efficacy of a dipeptidyl peptidase-4 inhibitor (sitagliptin) plus basal insulin with a basal-bolus insulin regimen for the management of patients with type 2 diabetes in general medicine and surgery in hospitals.We did a multicentre, prospective, open-label, non-inferiority randomised clinical trial (Sita-Hospital) in five hospitals in the USA, enrolling patients aged 18-80 years with type 2 diabetes and a random blood glucose concentration of 7·8-22·2 mmol/L who were being treated with diet or oral antidiabetic drugs or had a total daily insulin dose of 0·6 units per kg or less, admitted to general medicine and surgery services. We randomly assigned patients (1:1) to receive either sitagliptin plus basal glargine once daily (the sitagliptin-basal group) or a basal-bolus regimen with glargine once daily and rapid-acting insulin lispro or aspart before meals (the basal-bolus group) during the hospital stay. All other antidiabetic drugs were discontinued on admission. The randomisation was achieved by computer-generated tables with block stratification according to randomisation blood glucose concentrations (ie, higher or lower than 11·1 mmol/L). The primary endpoint of the trial was non-inferiority in mean differences between groups in their daily blood glucose concentrations during the first 10 days of therapy (point-of-care measurements; non-inferiority was deemed a difference1 mmol/L). The safety endpoints included hypoglycaemia and uncontrolled hyperglycaemia leading to treatment failure. All participants who received at least one dose of study drug were included in the analysis. This study is registered with ClinicalTrials.gov, number NCT01845831.Between Aug 23, 2013, and July 27, 2015, we recruited 279 patients, and randomly assigned 277 to treatment; 138 to sitagliptin-basal and 139 to basal-bolus. The length of stay in hospital was similar for both groups (median 4 days [IQR 3-8] vs 4 [3-8] days, p=0·54). The mean daily blood glucose concentration in the sitagliptin-basal group (9·5 mmol/L [SD 2·7]) was not inferior to that in the basal-bolus group 9·4 mmol/L [2·7]) with a mean blood glucose difference of 0·1 mmol/L (95% CI -0·6 to 0·7). No deaths occurred in this trial. Treatment failure occurred in 22 patients (16%) in the sitagliptin-basal group versus 26 (19%) in the basal-bolus group (p=0·54). Hypoglycaemia occurred in 13 patients (9%) in the sitagliptin-basal group and in 17 (12%) in the basal-bolus group (p=0·45). No differences in hospital complications were noted between groups. Seven patients (5%) developed acute kidney injury in the sitagliptin-basal group and six (4%) in the basal-bolus group. One patient (0·7%) developed acute pancreatitis (in the basal-bolus group).The trial met the non-inferiority threshold for the primary endpoint, because there was no significant difference between groups in mean daily blood glucose concentrations. Treatment with sitagliptin plus basal insulin is as effective and safe as, and a convenient alternative to, the labour-intensive basal-bolus insulin regimen for the management of hyperglycaemia in patients with type 2 diabetes admitted to general medicine and surgery services in hospital in the non-intensive-care setting.Merck.