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Background: Data on the use of Control‐IQ, the latest FDA‐approved automated insulin delivery (AID) system for people with T1D 6 years of age or older is still scarce, particularly regarding nonglycemic outcomes. Children with T1D and their parents are at higher risk for sleep disturbances. This study assesses sleep, psycho‐behavioral and glycemic outcomes of AID compared to sensor‐augmented pump therapy (SAP) therapy in young children with T1D and their parents. Methods: Thirteen parents and their young children (ages 7–10) on insulin pump therapy were enrolled. Children completed an initial 4‐week study with SAP using their own pump and a study CGM followed by a 4‐week phase of AID. Sleep outcomes for parents and children were evaluated through actigraphy watches. Several questionnaires were administered at baseline and at the end of each study phase. CGM data were used to assess glycemic outcomes. Results: Actigraphy data did not show any significant change from SAP to AID, except a reduction of number of parental awakenings during the night (p = 0.036). Parents reported statistically significant improvements in Pittsburgh Sleep Quality Index total score (p = 0.009), Hypoglycemia Fear Survey total score (p = 0.011), diabetes‐related distress (p = 0.032), and depression (p = 0.023). While on AID, time in range (70–180 mg/dL) significantly increased compared to SAP (p < 0.001), accompanied by a reduction in hyperglycemia (p = 0.001). Conclusions: These results suggest that use of AID has a positive impact on glycemic outcomes in young children as well as sleep and diabetes‐specific quality of life outcomes in their parents. [ABSTRACT FROM AUTHOR]

Background and Aim: Studies have increasingly identified sleep disturbances in people with T1D. Parents of young children with T1D may also be a particularly vulnerable population to sleep disturbances. Anecdotally, it is reported that use of CLC improves sleep quality and quantity in users but objective data on indirect users are not available. This study assesses sleep outcomes of CLC compared to SAP therapy in parents of children with T1D. Methods: Thirteen parents and their young children (ages 6-10) on insulin pump therapy were enrolled. Children completed an initial 4-week study with SAP using their own pump and a study CGM (Dexcom G6) followed by a 4-week phase of CLC (Control-IQ, Tandem Diabetes Care). Sleep was assessed in parents using actigraphy watches worn the last 10 days of each study phase. The Pittsburgh Sleep Quality Index (PSQI) questionnaire and the Hypoglycemia Fear Survey (HFS) were administered at baseline (BL) and following each study phase. Results: A statistically significant decrease was noted from BL to the end of the CLC phase of PSQI score (p=0.009) and the behavioral (p=0.005) and worry (p=0.045) HFS subscales. Even though statistical power was reduced by the number of participants, actigraphy data showed strong trends on several variables including an average increase of 14 minutes of total sleep time from SAP to CLC (p=0.068) and in people with high PSQI scores at BL (>median) a higher sleep efficiency (p=0.098) and lower wake after sleep onset (p=0.100). Notably, children significantly reduced their time spent in hypoglycemia (<70 mg/dl) at night from SAP to CLC (p=0.015). Conclusions: Though preliminary, these results suggest that use of CLC has a positive impact on both the quality and quantity of sleep in parents of children with T1D. A decrease in fear of hypoglycemia, endorsed by fewer nocturnal hypoglycemic episodes, might be associated with sleep improvement since previous studies have reported poorer sleep quality in parents with high levels of fear of hypoglycemia. Disclosure: A. Bisio: None. S.A. Brown: Research Support; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care, Tandem Diabetes Care, Tolerion, Inc. R. McFadden: None. H. Bonner: None. P.L. Yu: None. D.R. Cherñavvsky: Employee; Self; Dexcom, Inc. M.D. DeBoer: Research Support; Self; Tandem Diabetes Care. O. Khurshid: None. N. Kurtz: None. M.C. Oliveri: None. M. Pajewski: None. M. Schoelwer: Research Support; Self; Tandem Diabetes Care. M.K. Voelmle: Consultant; Self; Dexcom, Inc. C.A. Wakeman: Stock/Shareholder; Self; Dexcom, Inc., Tandem Diabetes Care. L. Gonder-Frederick: Other Relationship; Self; HFS-Global, LLC. Funding: Virginia Research Investment Fund [ABSTRACT FROM AUTHOR]

Abstract Introduction While the Accreditation Council for Graduate Medical Education limited first year resident-physicians to 16 consecutive work hours from 2011 to 2017, resident-physicians in their second year or higher were permitted to work up to 28 h consecutively. This paper describes the Randomized Order Safety Trial Evaluating Resident-physician Schedules (ROSTERS) study, a clustered-randomized crossover clinical trial designed to evaluate the effectiveness of eliminating traditional shifts of 24 h or longer for second year or higher resident-physicians in pediatric intensive care units (PICUs). Methods ROSTERS was a multi-center non-blinded trial in 6 PICUs at US academic medical centers. The primary aim was to compare patient safety between the extended duration work roster (EDWR), which included shifts ≥24 h, and a rapidly cycling work roster (RCWR), where shifts were limited to a maximum of 16 h. Information on potential medical errors was gathered and used for classification by centrally trained physician reviewers who were blinded to the study arm. Secondary aims were to assess the relationship of the study arm to resident-physician sleep duration, work hours and neurobehavioral performance. Results The study involved 6577 patients with a total of 38,821 patient days (n = 18,749 EDWR, n = 20,072 RCWR). There were 413 resident-physician rotations included in the study (n = 203 EDWR, n = 210 RCWR). Resident-physician questionnaire data were over 95% complete. Conclusions Results from data collected in the ROSTERS study will be evaluated for the impact of resident-physician schedule roster on patient safety outcomes in PICUs, and will allow for examination of a number of secondary outcome measures. ClinicalTrials.gov Identifier: NCT02134847 [ABSTRACT FROM AUTHOR]

Background: The effects on patient safety of eliminating extended-duration work shifts for resident physicians remain controversial., Methods: We conducted a multicenter, cluster-randomized, crossover trial comparing two schedules for pediatric resident physicians during their intensive care unit (ICU) rotations: extended-duration work schedules that included shifts of 24 hours or more (control schedules) and schedules that eliminated extended shifts and cycled resident physicians through day and night shifts of 16 hours or less (intervention schedules). The primary outcome was serious medical errors made by resident physicians, assessed by intensive surveillance, including direct observation and chart review., Results: The characteristics of ICU patients during the two work schedules were similar, but resident physician workload, described as the mean (±SD) number of ICU patients per resident physician, was higher during the intervention schedules than during the control schedules (8.8±2.8 vs. 6.7±2.2). Resident physicians made more serious errors during the intervention schedules than during the control schedules (97.1 vs. 79.0 per 1000 patient-days; relative risk, 1.53; 95% confidence interval [CI], 1.37 to 1.72; P<0.001). The number of serious errors unitwide were likewise higher during the intervention schedules (181.3 vs. 131.5 per 1000 patient-days; relative risk, 1.56; 95% CI, 1.43 to 1.71). There was wide variability among sites, however; errors were lower during intervention schedules than during control schedules at one site, rates were similar during the two schedules at two sites, and rates were higher during intervention schedules than during control schedules at three sites. In a secondary analysis that was adjusted for the number of patients per resident physician as a potential confounder, intervention schedules were no longer associated with an increase in errors., Conclusions: Contrary to our hypothesis, resident physicians who were randomly assigned to schedules that eliminated extended shifts made more serious errors than resident physicians assigned to schedules with extended shifts, although the effect varied by site. The number of ICU patients cared for by each resident physician was higher during schedules that eliminated extended shifts. (Funded by the National Heart, Lung, and Blood Institute; ROSTERS ClinicalTrials.gov number, NCT02134847.)., (Copyright © 2020 Massachusetts Medical Society.)

The sequence of neural responses to exogenous arterial pressure manipulation remains unclear, especially for extramedullary sites. We used functional magnetic resonance imaging procedures to visualize neural responses during pressor (phenylephrine) and depressor (sodium nitroprusside) challenges in seven isoflurane-anesthetized adult cats. Depressor challenges produced signal-intensity declines in multiple cardiovascular-related sites in the medulla, including the nucleus tractus solitarius, and caudal and rostral ventrolateral medulla. Signal decreases also emerged in the cerebellar vermis, inferior olive, dorsolateral pons, and right insula. Rostral sites, such as the amygdala and hypothalamus, increased signal intensity as arterial pressure declined. In contrast, arterial pressure elevation elicited smaller signal increases in medullary regions, the dorsolateral pons, and the right insula and signal declines in regions of the hypothalamus, with no change in deep cerebellar areas. Responses to both pressor and depressor challenges were typically lateralized. In a subset of animals, barodenervation resulted in rises and falls of blood pressure that were comparable to these resulting from the pharmacological challenges but different regional neural responses, indicating that the regional signal intensity responses did not derive from global perfusion effects but from baroreceptor mediation of central mechanisms. The findings demonstrate widespread lateralized distribution of neural sites responsive to blood pressure manipulation. The distribution and time course of neural responses follow patterns associated with early and late compensatory reactions.