Median Percentage Of Time Research Articles

Hepatocellular carcinoma surveillance, incidence, and tumor doubling times in patients cured of hepatitis C

BackgroundHepatocellular carcinoma (HCC) incidence and mortality vary by race/ethnicity and both are higher in Black patients than in Whites. For HCC surveillance, all cirrhotic patients are advised to undergo lifelong twice‐annual abdominal imaging. We investigated factors associated with surveillance and HCC incidence in a diverse HCC risk group, cirrhotic patients recently cured of hepatitis C virus (HCV) infection.MethodsIn this observational cohort study, all participants (n = 357) had advanced fibrosis/cirrhosis and were cured of HCV with antiviral treatment. None had Liver Imaging Reporting and Data System (LI‐RADS) 2–5 lesions prior to HCV cure. Ultrasound, computed tomography, and/or magnetic resonance imaging were used for surveillance.ResultsAt a median follow‐up of 40 months [interquartile range (IQR) = 28–48], the median percentage of time up‐to‐date with surveillance was 49% (IQR) = 30%–71%. The likelihood of receiving a first surveillance examination was not significantly associated with race/ethnicity, but was higher for patients with more advanced cirrhosis, for example, bilirubin [odds ratio (OR) = 3.8/mg/dL, p = 0.002], private insurance (OR = 3.4, p = 0.006), and women (OR = 2.3, p = 0.008). The likelihood of receiving two or three examinations was significantly lower for non‐Hispanic Blacks and Hispanics versus non‐Hispanic Whites (OR = 0.39, and OR = 0.40, respectively, p < 0.005 for both) and for patients with higher platelet counts (OR = 0.99/10,000 cells/µl, p = 0.01), but higher for patients with private insurance (OR = 2.8, p < 0.001). Incident HCC was associated with higher bilirubin (OR = 1.7, p = 0.02) and lower lymphocyte counts (OR = 0.16, p = 0.01).ConclusionsContrary to best practices, HCC surveillance was associated with sociodemographic factors (insurance status and race/ethnicity) among patients cured of HCV. Guideline‐concordant surveillance is needed to address healthcare disparities.

Examining Social Vulnerability and the Association With COVID-19 Incidence in Harris County, Texas.

Studies have investigated the association between social vulnerability and SARS-CoV-2 incidence. However, few studies have examined small geographic units such as census tracts, examined geographic regions with large numbers of Hispanic and Black populations, controlled for testing rates, and incorporated stay-at-home measures into their analyses. Understanding the relationship between social vulnerability and SARS-CoV-2 incidence is critical to understanding the interplay between social determinants and implementing risk mitigation guidelines to curtail the spread of infectious diseases. The objective of this study was to examine the relationship between CDC's Social Vulnerability Index (SVI) and SARS-CoV-2 incidence while controlling for testing rates and the proportion of those who stayed completely at home among 783 Harris County, Texas census tracts. SARS-CoV-2 incidence data were collected between May 15 and October 1, 2020. The SVI and its themes were the primary exposures. Median percent time at home was used as a covariate to measure the effect of staying at home on the association between social vulnerability and SARS-CoV-2 incidence. Data were analyzed using Kruskal Wallis and negative binomial regressions (NBR) controlling for testing rates and staying at home. Results showed that a unit increase in the SVI score and the SVI themes were associated with significant increases in SARS-CoV-2 incidence. The incidence risk ratio (IRR) was 1.090 (95% CI, 1.082, 1.098) for the overall SVI; 1.107 (95% CI, 1.098, 1.115) for minority status/language; 1.090 (95% CI, 1.083, 1.098) for socioeconomic; 1.060 (95% CI, 1.050, 1.071) for household composition/disability, and 1.057 (95% CI, 1.047, 1.066) for housing type/transportation. When controlling for stay-at-home, the association between SVI themes and SARS-CoV-2 incidence remained significant. In the NBR model that included all four SVI themes, only the socioeconomic and minority status/language themes remained significantly associated with SARS-CoV-2 incidence. Community-level infections were not explained by a communities' inability to stay at home. These findings suggest that community-level social vulnerability, such as socioeconomic status, language barriers, use of public transportation, and housing density may play a role in the risk of SARS-CoV-2 infection regardless of the ability of some communities to stay at home because of the need to work or other reasons.

Short communication: Differences in clinical outcomes according to the healthcare regime in Colombian patients with rheumatoid arthritis

Introduction/ObjectivesRheumatoid arthritis (RA) is a burdensome disease from both individual and societal perspectives, in which access to a rheumatologist plays a pivotal role in disease activity and reduction of its impact. We describe preliminary results of our study aimed at exploring whether healthcare regime affiliation influences disease outcomes of Colombian patients with RA. Materials and methodsWe performed a retrospective observational study of RA patients (2010 ACR/EULAR classification criteria) with at least 3 assessments in rheumatology clinics from different healthcare regimes: Contributory (CR), Subsidized (SR), a centre of clinical excellence (C3) that follows CR patients. We retrieved data from clinical charts including a follow-up period of 2 years. ResultsWe included one hundred and sixty patients (C3: 79 [49.4%], CR: 26 [16.2%], SR: 55 [34.2%]). Median initial age was 54 years (IQR 48–62) and most patients were women (77.8%). Of the patients, 79% had established RA and 70% had high disease activity at the beginning of the follow-up. We observed statistical differences between groups with regards to (1) median time to scheduled visits, (2) percentage of visits accomplished in scheduled time, (3) median time to real visit, (4) adherence, (5) median percentage of time in high disease activity, and (6) percentage of patients in high disease activity at the end of follow-up. The best outcomes were observed in the C3 cohort. ConclusionsAccess opportunity and clinical outcomes of Colombian patients with RA appear to differ between healthcare regimes. Although systematic bias may be present due to sample size, these data imply the healthcare regime is a major determinant of disease outcomes.

One Year Real-World Use of the Control-IQ Advanced Hybrid Closed-Loop Technology.

Background: The t:slim X2™ insulin pump with Control-IQ® technology from Tandem Diabetes Care is an advanced hybrid closed-loop system that was first commercialized in the United States in January 2020. Longitudinal glycemic outcomes associated with real-world use of this system have yet to be reported.Methods: A retrospective analysis of Control-IQ technology users who uploaded data to Tandem's t:connect® web application as of February 11, 2021 was performed. Users age ≥6 years, with >2 weeks of continuous glucose monitoring (CGM) data pre- and >12 months post-Control-IQ technology initiation were included in the analysis.Results: In total 9451 users met the inclusion criteria, 83% had type 1 diabetes, and the rest had type 2 or other forms of diabetes. The mean age was 42.6 ± 20.8 years, and 52% were female. Median percent time in automation was 94.2% [interquartile range, IQR: 90.1%–96.4%] for the entire 12-month duration of observation, with no significant changes over time. Of these users, 9010 (96.8%) had ≥75% of their CGM data available, that is, sufficient data for reliable computation of CGM-based glycemic outcomes. At baseline, median percent time in range (70–180 mg/dL) was 63.6 (IQR: 49.9%–75.6%) and increased to 73.6% (IQR: 64.4%–81.8%) for the 12 months of Control-IQ technology use with no significant changes over time. Median percent time <70 mg/dL remained consistent at ∼1% (IQR: 0.5%–1.9%).Conclusion: In this real-world use analysis, Control-IQ technology retained, and to some extent exceeded, the results obtained in randomized controlled trials, showing glycemic improvements in a broad age range of people with different types of diabetes.

Use of Continuous Glucose Monitoring for evaluation of hypoglycemia pre- and post-operatively for patients undergoing Total Pancreatectomy with Autologous Islet Cell Transplant.

Total pancreatectomy with autologous islet transplant (TPAIT) is indicated for patients with chronic pancreatitis to improve quality of life while reducing complications from hypoglycemia. Continuous glucose monitoring (CGM) was used to assess overall islet function and the incidence of hypoglycemia pre- and post-operatively. Nineteen patients who underwent TPAIT at a single center from 2018 to 2020 were included. Pre-operatively, patients were defined by diabetic status. HbA1c, stimulated C-peptide, and CGM were used to characterize glycemic function. Pre-operatively, three patients had diabetes, and 16 patients did not have diabetes. Eight out of 16 non-diabetic patients were insulin independent (50%). Of six non-diabetic patients with>10% hypoglycemia on pre-operative CGM, 33% were insulin-independent post-operatively (P=.3). Of non-diabetic patients with ≥ 80% time in the euglycemic range, 62% were insulin-independent post-operatively (P=.2). For patients without diabetes, the median percent time in hypoglycemic range was reduced from 8% to 1% (P=.001). Delta C-peptide had a positive correlation with islet yield (P=.03). Conventional evaluation of TPAIT patients assesses primarily beta cell function. As pancreatogenic diabetes is concerning principally for the risk of hypoglycemia, assessment of alpha cell function can improve the quality of care. CGM better captures islet function and increases the identification of hypoglycemia.

Effectiveness of a closed-loop control system and a virtual educational camp for children and adolescents with type 1 diabetes: A prospective, multicentre, real-life study.

To evaluate the impact of a virtual educational camp (vEC) on glucose control in children and adolescents with type 1 diabetes using a closed-loop control (CLC) system. This was a prospective multicentre study of children and adolescents with type 1 diabetes using the Tandem Basal-IQ system. Insulin pumps were upgraded to Control-IQ, and children and their parents participated in a 3-day multidisciplinary vEC. Clinical data, glucose metrics and HbA1c were evaluated over the 12 weeks prior to the Control-IQ update and over the 12 weeks after the vEC. Forty-three children and adolescents (aged 7-16 years) with type 1 diabetes and their families participated in the vEC. The median percentage of time in target range (70-180 mg/dL; TIR) increased from 64% (interquartile range [IQR] 56%-73%) with Basal-IQ to 76% (IQR 71%-81%) with Control-IQ (P< .001). After the vEC, more than 75% of participants achieved a TIR of more than 70%. The percentage of time between 180 and 250 mg/dL and above 250 mg/dL decreased by 5% (P< .01) and 6% (P< .01), respectively, while the time between 70 and 54 mg/dL and below 54 mg/dL remained low and unaltered. HbA1c decreased by 0.5% (P< .01). There were no episodes of diabetic ketoacidosis or severe hypoglycaemia. In this study of children managing their diabetes in a real-world setting, more than 75% of children who participated in a vEC after starting a CLC system could obtain and maintain a TIR of more than 70%. The vEC was feasible and resulted in a significant and persistent improvement in TIR in children and adolescents with type 1 diabetes.

1 Correlation Between New York City Hot Spotting Policy and Mobility to Reduce COVID-19 Spread

In October 2020, New York State initiated a micro-cluster strategy (“hot spotting”) that divides into three categories based on COVID-19 cases and hospital capacity, each with successively more restrictions: Yellow, Orange, and Red Zones. Our objectives were to evaluate the influence of hot spotting on mobility and subsequent mortality, and then to identify underlying social determinants of health associated with the neighborhoods most affected by hot spotting. We combine several data sources in our analysis. Time-dependent data were obtained from SafeGraph for cellphone mobility at the Census Block Group, New York State Governor’s Office for hot spotting, school and indoor dining, and NYC Department of Health and Mental Hygiene (DOHMH) for COVID-19 cases and mortality. Using the DOHMH’s “Modified Zip Code Tabulation Areas” (MODZCTA), we matched these to community-level data obtained from 2018 American Community Survey 5-year estimates for population density. Our main outcomes are Average Median Percentage Time Home (AMPTH) and Device-Weighted Average Median Percentage Time Home (DWAMPTH) from SafeGraph Social Distancing Metrics summarized to MODZCTA boundaries. Home is defined as the common nighttime location of each mobile device over a 6-week period to a Geohash-7 granularity (∼153m x ∼153m). We implemented the Wilcoxon rank-sum test with a <0.05 p-value threshold for each day since hot spotting policy to compare MODZCTA with any of the Zone's designation to those without designation. Our main outcomes are Average Median Percentage Time Home (AMPTH) and Device-Weighted Average Median Percentage Time Home (DWAMPTH) from SafeGraph Social Distancing Metrics summarized to MODZCTA boundaries. NYC residents from October 5, 2020, to December 31, 2020 (87 days total) using the 177 MODZCTA within NYC as geographic unit of analysis. For the AMPTH measurement, MODZCTAs with hot spotting Zone's designation had 84 days (95% of the days) with statistically significantly lower mobility than non-intervention MODZCTAs, and for the DWAMPTH measurement, 83 days (97% of the days) had statistically significantly lower mobility. 58 of the days had p-value<0.001 for AMPTH and 49 had p-value<0.001 for DWAMPTH, and only a minority of days had p-value>0.1 (2 days for AMPTH and 3 for DWAMPTH). Looking at individual boroughs, Brooklyn had 42 statistically significant days for AMPTH and 49 for DWAMPTH, while Queens had 12 statistically significant days for AMPTH and 7 for DWAMPTH. New York State’s micro-cluster focus Zones is associated with decreased mobility in high COVID-19 prevalence areas. Our study suggests that shutdowns targeted at small geographic areas may reduce mobility and thus can potentially help control COVID-19 spread.

216-OR: A Random-Order, Double-Blinded, Placebo-Controlled Study of the Bionic Pancreas in the Bihormonal vs. Insulin-Only Configurations Using Two Different Glucose Targets in Adults with Type 1 Diabetes in the Home-Use Setting

Objective: We evaluated the glycemic outcomes with 2 glucose targets in both configurations (bihormonal and insulin-only) of the bionic pancreas (BP) in a home-use study of adults with type 1 diabetes. Research Design and Methods: 20 participants completed a double-blinded, placebo-controlled (glucagon vs. placebo), random-order, four-arm cross-over trial comparing the bihormonal (BH) and insulin-only (IO) configurations of the BP, each using 2 glucose targets (110 and 130 mg/dl); each arm lasted 3 days. Co-primary outcomes were continuous glucose monitor (CGM) mean glucose level and time &amp;lt;54 mg/dl. Results: For the BH vs. IO configurations using the 130 mg/dl glucose target, the mean CGM glucose was 156±12 vs. 161±17 mg/dl (p=0.11) and the median percentage of time with CGM glucose &amp;lt;54 mg/dl was 0.0% [IQR 0-0.52%] vs. 0.0% [0-0.35%] (p=0.45). For the BH vs. IO configurations using the 110 mg/dl glucose target, the mean CGM glucose was 148±17 vs. 153±15 mg/dl (p=0.21) and the median percentage of time with CGM glucose &amp;lt;54 mg/dl was 0.0% [0-0%] vs. 0.52% [0.0-1.0%] (p=0.002). The nominal differences in mean CGM glucose between the 110 mg/dl and the 130 mg/dl glucose targets (8 mg/dl in each case) were not statistically significant in either the IO or BH configuration (p&amp;gt;0.05). There was less hypoglycemia in the IO configuration, but not the BH configuration, when using the 130 mg/dl target vs. the 110 mg/dl target (p=0.03). Conclusions: Both configurations of the BP provided safe and effective glycemic control using both glucose targets during home use. Hypoglycemia was lower with the BH configuration vs. the IO configuration using the 110 mg/dl target. Hypoglycemia was lower in the IO configuration when using the 130 mg/dl target vs. the 110 mg/dl target. Larger and longer studies will be needed to quantify differences in outcomes between the IO and BH configurations of the BP. Disclosure L. E. Castellanos: None. C. A. Balliro: Consultant; Self; Beta Bionics, Inc., Novo Nordisk. J. Sherwood: None. M. Tuffaha: None. M. Hillard: None. R. Selagamsetty: Employee; Self; Beta Bionics, Inc. F. El-khatib: Employee; Self; Beta Bionics, Inc., Stock/Shareholder; Self; Beta Bionics, Inc. E. Damiano: Other Relationship; Self; Beta Bionics, Inc., Stock/Shareholder; Spouse/Partner; Beta Bionics, Inc. S. J. Russell: Advisory Panel; Self; Companion Medical, ConvaTec Inc., Consultant; Self; Beta Bionics, Inc., Novo Nordisk, Other Relationship; Self; Beta Bionics, Inc., Research Support; Self; Beta Bionics, Inc., Novo Nordisk, Zealand Pharma A/S.

ATTD 2021 Invited Speaker Abstracts.

ATTD 2021 Invited Speaker Abstracts.

Glycemic Patterns Are Distinct in Post-Bariatric Hypoglycemia After Gastric Bypass (PBH-RYGB).

Severe hypoglycemia with neuroglycopenia, termed post-bariatric hypoglycemia (PBH). typically occurs postprandially, but it is also reported after activity or mid-nocturnally. To quantify glycemia, glycemic variability, and magnitude/duration of low sensor glucose (SG) values in patients with PBH after Roux-en-Y gastric bypass (PBH-RYGB). This retrospective analysis of data from an academic medical center included individuals with PBH-RYGB (n = 40), reactive hypoglycemia without gastrointestinal surgery (Non-Surg Hypo, n = 20), prediabetes (Pre-DM, n = 14), newly diagnosed T2D (n = 5), and healthy controls (HC, n = 38). Masked continuous glucose monitoring (Dexcom G4) was used to assess patterns over 24 hours, daytime (6 am-midnight) and nighttime (midnight-6 am). Prespecified measures included mean and median SG, variability, and percent time at thresholds of sensor glucose. Mean and median SG were similar for PBH-RYGB and HC (mean: 99.8 ± 18.6 vs 96.9 ± 10.2 mg/dL; median: 93.0 ± 14.8 vs 94.5 ± 7.4 mg/dL). PBH-RYGB had a higher coefficient of variation (27.3 ± 6.8 vs 17.9 ± 2.4%, P < 0.0001) and range (154.5 ± 50.4 vs 112.0 ± 26.7 mg/dL, P < 0.0001). Nadir was lowest in PBH-RYGB (42.5 ± 3.7 vs HC 49.0 ± 11.9 mg/dL, P = 0.0046), with >2-fold greater time with SG < 70 mg/dL vs HC (7.7 ± 8.4 vs 3.2 ± 4.1%, P = 0.0013); these differences were greater at night (12.6 ± 16.9 vs 1.0 ± 1.5%, P < 0.0001). Non-Surg Hypo also had 4-fold greater time with SG < 70 at night vs HC (SG < 70: 4.0 ± 5.9% vs 1.0 ± 1.5%), but glycemic variability was not increased. Patients with PBH-RYGB experience higher glycemic variability and frequency of SG < 70 compared to HC, especially at night. These data suggest that additional pathophysiologic mechanisms beyond prandial changes contribute to PBH.

Treatment of Gastroesophageal Reflux Disease After Lung Transplant Using Radiofrequency Ablation to the Lower Esophageal Sphincter (Stretta Procedure).

Gastroesophageal reflux disease (GERD) is associated with chronic lung allograft dysfunction after lung transplant. Treating GERD after lung transplant has been shown to improve lung allograft function. This case series describes the efficacy of the Stretta procedure to control GERD after lung transplant at our institution. Eleven patients underwent the Stretta procedure at our institution for GERD after lung transplant during the years 2016-2017. Pre- and post-Stretta reflux parameters were gathered. Pulmonary function was followed up until subsequent fundoplication surgery, death, or end of study observation. Reflux on esophagram was noted in 9 patients before Stretta and 8 patients after Stretta. The median number of acid reflux events was 31.5 vs. 26 after Stretta (P = .95), and median percent time in reflux was 17.7% before vs. 14.5% after Stretta (P = .76). Median DeMeester score before Stretta was 65.5 (range: 33.2-169.8) vs. 42.5 (range: 19.2-109.8) after the procedure (P = .14). Median lower esophageal resting pressure was 20.7mmHg (n = 7) compared to 25.9mmHg (n = 9) on post-Stretta follow-up (P = .99). Median FEV1% predicted was 84% (41-97%) before compared to 71% (23-108%) at 1year after the procedure (P = .14). Seven patients required fundoplication surgery for continued reflux. All patients were on triple immunosuppression, most commonly prednisone, tacrolimus, and mycophenolate (n = 9). The Stretta procedure did not provide expected results at our institution after lung transplant surgery. Based on our limited series, we do not recommend routine use of the Stretta procedure for management of GERD in lung transplant patients.

Effect of Intra-Operative Hypothermia on Post-Operative Morbidity in Patients with Colorectal Cancer.

Background: Current guidelines recommend maintaining intra-operative normothermia to avoid surgical site infections (SSI) after colorectal cancer surgery. The aim of this study was to assess whether compliance with normothermia as part of temperature management measures is an effective strategy to reduce post-operative SSI and complications. Patients and Methods: This was a cohort study of patients undergoing surgery for primary colorectal cancer in 2011-2017 in a large teaching hospital in which temperature management using the Bair Hugger™ system (3M™ Center, St. Paul, MN) was standard care. Data from the prospective Dutch Surgical Audit (DCRA) database were complemented by highly granular intra-operative central body temperature data. A multivariable logistic regression model was used. Results: A total of 1,015 patients undergoing surgery for primary colorectal cancer were included. Temperature outcomes for the entire study cohort were as follows: mean temperature was 36.3°C (standard deviation [SD] ±0.5°C), median temperature nadir was 35.8°C (interquartile range [IQR] 35.6°C-36.1°C), median percentage of time at nadir was 2.0% (IQR 0.8%-10.7%), and median percentage of time less than 36.0°C was 1.0% (IQR 0.0%-33.3%). Thirty-day SSI rate was 10% (n = 101). Logistic regression models adjusting for gender, diabetes mellitus, body mass index (BMI), rectal cancer, duration of surgery, open surgery, emergency surgery, and period of surgery showed no association between any of the four temperature outcomes and SSI. Multivariable analysis also failed to show an association between intra-operative hypothermia and 30-day complications, mortality, or re-admission. Conclusions: In a hospital in which temperature management is standard care, intra-operative hypothermia and SSI rates in patients undergoing colorectal cancer surgery were low. Compliance with normothermia appears to be an effective strategy to reduce SSI.

Cryoablation or Drug Therapy for Initial Treatment of Atrial Fibrillation

BackgroundGuidelines recommend a trial of one or more antiarrhythmic drugs before catheter ablation is considered in patients with atrial fibrillation. However, first-line ablation may be more effective in maintaining sinus rhythm.MethodsWe randomly assigned 303 patients with symptomatic, paroxysmal, untreated atrial fibrillation to undergo catheter ablation with a cryothermy balloon or to receive antiarrhythmic drug therapy for initial rhythm control. All the patients received an implantable cardiac monitoring device to detect atrial tachyarrhythmia. The follow-up period was 12 months. The primary end point was the first documented recurrence of any atrial tachyarrhythmia (atrial fibrillation, atrial flutter, or atrial tachycardia) between 91 and 365 days after catheter ablation or the initiation of an antiarrhythmic drug. The secondary end points included freedom from symptomatic arrhythmia, the atrial fibrillation burden, and quality of life.ResultsAt 1 year, a recurrence of atrial tachyarrhythmia had occurred in 66 of 154 patients (42.9%) assigned to undergo ablation and in 101 of 149 patients (67.8%) assigned to receive antiarrhythmic drugs (hazard ratio, 0.48; 95% confidence interval [CI], 0.35 to 0.66; P<0.001). Symptomatic atrial tachyarrhythmia had recurred in 11.0% of the patients who underwent ablation and in 26.2% of those who received antiarrhythmic drugs (hazard ratio, 0.39; 95% CI, 0.22 to 0.68). The median percentage of time in atrial fibrillation was 0% (interquartile range, 0 to 0.08) with ablation and 0.13% (interquartile range, 0 to 1.60) with antiarrhythmic drugs. Serious adverse events occurred in 5 patients (3.2%) who underwent ablation and in 6 patients (4.0%) who received antiarrhythmic drugs.ConclusionsAmong patients receiving initial treatment for symptomatic, paroxysmal atrial fibrillation, there was a significantly lower rate of atrial fibrillation recurrence with catheter cryoballoon ablation than with antiarrhythmic drug therapy, as assessed by continuous cardiac rhythm monitoring. (Funded by the Cardiac Arrhythmia Network of Canada and others; EARLY-AF ClinicalTrials.gov number, NCT02825979.)

Anticipation of Historical Exercise Patterns by a Novel Artificial Pancreas System Reduces Hypoglycemia During and After Moderate-Intensity Physical Activity in People with Type 1 Diabetes.

Objective: Physical activity is a major challenge to glycemic control for people with type 1 diabetes. Moderate-intensity exercise often leads to steep decreases in blood glucose and hypoglycemia that closed-loop control systems have so far failed to protect against, despite improving glycemic control overall. Research Design and Methods: Fifteen adults with type 1 diabetes (42 ± 13.5 years old; hemoglobin A1c 6.6% ± 1.0%; 10F/5M) participated in a randomized crossover clinical trial comparing two hybrid closed-loop (HCL) systems, a state-of-the-art hybrid model predictive controller and a modified system designed to anticipate and detect unannounced exercise (APEX), during two 32-h supervised admissions with 45 min of planned moderate activity, following 4 weeks of data collection. Primary outcome was the number of hypoglycemic episodes during exercise. Continuous glucose monitor (CGM)-based metrics and hypoglycemia are also reported across the entire admissions. Results: The APEX system reduced hypoglycemic episodes overall (9 vs. 33; P = 0.02), during exercise (5 vs. 13; P = 0.04), and in the 4 h following (2 vs. 11; P = 0.02). Overall CGM median percent time <70 mg/dL decreased as well (0.3% vs. 1.6%; P = 0.004). This protection was obtained with no significant increase in time >180 mg/dL (18.5% vs. 16.6%, P = 0.15). Overnight control was notable for both systems with no hypoglycemia, median percent in time 70-180 mg/dL at 100% and median percent time 70-140 mg/dL at ∼96% for both. Conclusions: A new closed-loop system capable of anticipating and detecting exercise was proven to be safe and feasible and outperformed a state-of-the-art HCL, reducing participants' exposure to hypoglycemia during and after moderate-intensity physical activity. ClinicalTrials.gov NCT03859401.

Atrial fibrillation ablation success defined by duration of recurrence on cardiac implantable electronic devices.

Ablation for atrial fibrillation (AF) has emerged as an effective method of rhythm control. This exploratory analysis aimed to determine how various measures of recurrence would influence the definition of treatment success. Using an electronic health record data set from January 2007 to June 2019 linked with Medtronic cardiac implantable electronic device (CIED) data, patients who underwent a first AF ablation procedure following CIED implantation were identified. Data were analyzed for recurrence of AF stratified by varying definitions of successful ablation. The performance of various simulated external AF monitoring strategies was assessed. A total of 665 patients were analyzed including 248 with paroxysmal AF (mean age: 66.2 ± 9.3 years, 73.0% male) and 417 patients with persistent AF (mean age: 67.3 ± 9.0 years, 73.6% male). Among patients with paroxysmal AF, survival free from recurrence at 1 year ranged from 28.2% to 72.1% (>6 min and >23 h thresholds, respectively) with an overall median percentage of time in AF reduction of 99.6%. Among patients with persistent AF, survival free from recurrence at 1 year ranged from 24.9% to 60.0% (>6 min and 7 consecutive days > 23 h thresholds, respectively) with an overall median percentage of time in AF reduction of 99.3%. A single 7-day monitoring strategy had a sensitivity of less than 50% for detecting AF greater than 6 min in patients with paroxysmal and persistent AF. In this real-world data set of AF patients with CIEDs undergoing catheter ablation, treatment success varied substantially with different definitions of minimally required AF duration and is significantly impacted by the method of recurrence detection.

A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes

BackgroundA closed-loop system of insulin delivery (also called an artificial pancreas) may improve glycemic outcomes in children with type 1 diabetes.MethodsIn a 16-week, multicenter, randomized, open-label, parallel-group trial, we assigned, in a 3:1 ratio, children 6 to 13 years of age who had type 1 diabetes to receive treatment with the use of either a closed-loop system of insulin delivery (closed-loop group) or a sensor-augmented insulin pump (control group). The primary outcome was the percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter, as measured by continuous glucose monitoring.ResultsA total of 101 children underwent randomization (78 to the closed-loop group and 23 to the control group); the glycated hemoglobin levels at baseline ranged from 5.7 to 10.1%. The mean (±SD) percentage of time that the glucose level was in the target range of 70 to 180 mg per deciliter increased from 53±17% at baseline to 67±10% (the mean over 16 weeks of treatment) in the closed-loop group and from 51±16% to 55±13% in the control group (mean adjusted difference, 11 percentage points [equivalent to 2.6 hours per day]; 95% confidence interval, 7 to 14; P<0.001). In both groups, the median percentage of time that the glucose level was below 70 mg per deciliter was low (1.6% in the closed-loop group and 1.8% in the control group). In the closed-loop group, the median percentage of time that the system was in the closed-loop mode was 93% (interquartile range, 91 to 95). No episodes of diabetic ketoacidosis or severe hypoglycemia occurred in either group.ConclusionsIn this 16-week trial involving children with type 1 diabetes, the glucose level was in the target range for a greater percentage of time with the use of a closed-loop system than with the use of a sensor-augmented insulin pump. (Funded by Tandem Diabetes Care and the National Institute of Diabetes and Digestive and Kidney Diseases; ClinicalTrials.gov number, NCT03844789.)

A preliminary assessment of vital-signs-integrated patient-assisted intravenous opioid analgesia (VPIA) for postsurgical pain

BackgroundWe developed a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia (VPIA) analgesic infusion pump, a closed-loop vital signs monitoring and drug delivery system which embodied in a novel algorithm that took into account patients’ vital signs (oxygen saturation, heart rate). The system aimed to allow responsive titration of personalized pain relief to optimize pain relief and reduce the risk of respiratory depression. Moreover, the system would be important to enable continuous monitoring of patients during delivery of opioid analgesia.MethodsNineteen patients who underwent elective gynecological surgery with postoperative patient controlled analgesia (PCA) with morphine were recruited. The subjects were followed up from their admission to the recovery room/ ward for at least 24 h until assessment of patient satisfaction on the VPIA analgesic infusion pump.ResultsThe primary outcome measure of incidence of oxygen desaturation showed all patients had at least one episode of oxygen desaturation (< 95%) during the study period. Only 6 (31.6%) patients had oxygen desaturation that persisted for more than 5 min. The median percentage time spent during treatment that oxygen saturation fell below 95% was 1.9%. Fourteen (73.7%) out of 19 patients encountered safety pause, due to transient oxygen desaturation or bradycardia. The patients’ median [IQR] pain scores at rest and at movement after post-op 24 h were 0.0 [2.0] and 3.0 [2.0], respectively. The average morphine consumption in the first 24 h was 12.5 ± 7.1 mg. All patients were satisfied with their experience with the VPIA analgesic infusion pump.ConclusionsThe use of VPIA analgesic infusion pump, when integrated with continuous vital signs monitor and variable lockout algorithm, was able to provide pain relief with good patient satisfaction.Trial registrationThis study was registered on clinicaltrials.gov registry (NCT02804022) on 28 Feb 2016.

98-LB: Individual Glycemic Response to Ultra-Rapid vs. Rapid Insulin Delivered Automatically with the Ilet Bionic Pancreas System

In a recent multicenter, random-order, home-use trial (NCT03565666), we examined automated glycemic control with the insulin-only configuration of the bionic pancreas (BP) using subjects’ typical insulin analogue, BP-T (aspart, n=7 or lispro, n=27), versus using the ultra-rapid faster aspart, BP-F. The dosing algorithm was identical in both arms and used the same setting for insulin absorption speed (tmax=65 minutes). The mean CGM glucose (CGMG) was similar between the BP-F and BP-T arms (154±11 vs. 155±13 mg/dl), as was the median percent time &amp;lt;54 mg/(0.6% [0.2-1.1%] vs. 0.6% [0-1.3%]). We used an autoregressive time series model to determine statistical significance for differences between the BP-F and BP-T arms in individual subjects. Nine subjects had a significantly lower mean CGMG during the BP-F arm (by 13±8 mg/dl), 10 subjects had a significantly higher mean CGMG during the BP-F arm (by 10±5 mg/dl), and 15 subjects had no significant difference between arms (nominal difference 2±2 mg/dl). One subject with a significantly lower mean CGMG in the BP-F arm also had a significant decrease of 1.4% in time &amp;lt;54 mg/dl (~20 minutes per day), one subject with no difference in mean CGMG between arms had a significant increase of 1.4% in time &amp;lt;54 mg/dl in the BP-F arm, and 32 subjects had no significant differences in time &amp;lt;54 mg/dl between arms. There was a statistically significant reduction in mean CGMG from the use of Fiasp without adjustment of the setting for insulin absorption speed for some subjects, but a similar number saw a significant increase in mean CGMG, while there was no difference for the remainder of subjects. Other studies are under way to test whether adjusting the BP insulin delivery algorithm tmax setting will allow more subjects to benefit from the use of faster aspart in the iLet. Disclosure J. Sherwood: None. H. Zheng: None. C.A. Balliro: None. L. Ekhlaspour: None. B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Medtronic. Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. F. El-Khatib: Other Relationship; Self; Beta Bionics, Inc. E. Damiano: Board Member; Self; Beta Bionics, Inc. Employee; Self; Beta Bionics, Inc. Stock/Shareholder; Self; Beta Bionics, Inc. Stock/Shareholder; Spouse/Partner; Beta Bionics, Inc. S.J. Russell: Consultant; Self; Beta Bionics, Inc., ConvaTec Inc., Novo Nordisk A/S, Senseonics. Research Support; Self; Beta Bionics, Inc., Novo Nordisk A/S, Zealand Pharma A/S. Stock/Shareholder; Self; Companion Medical. Other Relationship; Self; Ascensia Diabetes Care, Roche Diabetes Care. Funding National Institutes of Health

898-P: Benefit of Continuous Glucose Monitoring (CGM) in Reducing Hemoglobin A1c Is Sustained through 12 Months of Use among Adolescents and Young Adults with Type 1 Diabetes (T1D)

The CGM Intervention in Teens and Young Adults (CITY) trial demonstrated reductions in hemoglobin A1c (HbA1c) and hypoglycemia using CGM compared with intermittent blood glucose monitoring over a 6-month period. To determine if this improvement would be sustained, we evaluated outcomes in participants who continued CGM use through 12 months. The study was completed by 70 of 74 (95%) in the CGM group (43% female, median age 17 yrs, 67% non-Hispanic white, and 47% insulin pump users). Central-lab measured HbA1c and CGM measured glycemic outcomes at 12 months were compared with baseline (CGM at baseline was masked). HbA1c decreased from 8.9% at baseline to 8.3% at 12 months (p&amp;lt;0.001) (Table). Time spent in range 70-180 mg/dL was 38% at baseline and 41% at 12 months (P=0.3). Median percent time &amp;lt;70 mg/dL was reduced from 3.4% (49 min/day) at baseline to 1.1% (16 min/day) at 12 months (p&amp;lt;0.001). Similar improvements were observed for time &amp;lt;54 mg/dL with a decrease from a median of 1.0% (14 minutes/day) at baseline to 0.1% (&amp;lt;2 minutes/day) at 12 months. Glycemic variability measured by coefficient of variation was reduced from 42% at baseline to 37% at 12 months (p&amp;lt;0.001). These results demonstrate improvements in outcomes for teens and young adults with CGM use over a 12-month period with substantial improvements in HbA1c and reductions in hypoglycemia. Disclosure K. Miller: None. L. Kanapka: None. C. Bauza: None. L.M. Laffel: Advisory Panel; Self; Roche Diabetes Care. Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., ConvaTec Inc., Dexcom, Inc., Insulet Corporation, Insulogic LLC, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Novo Nordisk Inc., Sanofi US. Funding The Leona M. and Harry B. Helmsley Charitable Trust; Dexcom, Inc.

Continuous glucose monitor use with and without remote monitoring in pregnant women with type 1 diabetes: A pilot study.

BackgroundTo examine whether continuous glucose monitoring (CGM) with remote monitoring by followers (family/friends) changes glucose management, follower interventions, and health outcomes compared to CGM alone in pregnant women with diabetes.MethodsWe prospectively stratified first trimester pregnant women with Type 1 Diabetes to CGM Share (remote monitoring) or CGM Alone. We enrolled a main follower per woman. We retrospectively acquired data for pregnant women who did not use CGM (no CGM). We compared hemoglobin A1c (HbA1c) between groups. We compared sensor glucose, follower interventions, and gestational outcomes between CGM Alone and CGM Share. Longitudinal mixed effects models were used for analyses of changes in outcomes over time.ResultsHbA1c decreased in all groups throughout pregnancy and was significantly lower over time in women using CGM Share (n = 15) compared to CGM Alone (n = 13) or no CGM (n = 8) (p = 0.0042). CGM Share users had lower median sensor glucose levels (p = 0.0331) and percent time spent >180 mg/dL (p = 0.0228) across pregnancy. There were no significant differences in maternal and fetal outcomes between groups. CGM Share followers had more alerts for hypoglycemia, but did fewer interventions.ConclusionsIn this small pilot study, use of CGM with remote monitoring improved some glycemic metrics in pregnant women with diabetes.