Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe.

Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe.

Diabetes Care. 2016 May 10;

Authors: Del Favero S, Boscari F, Messori M, Rabbone I, Bonfanti R, Sabbion A, Iafusco D, Schiaffini R, Visentin R, Calore R, Leal Moncada Y, Galasso S, Galderisi A, Vallone V, Di Palma F, Losiouk E, Lanzola G, Tinti D, Rigamonti A, Marigliano M, Zanfardino A, Rapini N, Avogaro A, Chernavvsky D, Magni L, Cobelli C, Bruttomesso D

Abstract
OBJECTIVE: The Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5- to 9-year old children during a camp.
RESEARCH DESIGN AND METHODS: A total of 30 children, 5- to 9-years old, with type 1 diabetes completed an outpatient, open-label, randomized, crossover trial. Three days with an artificial pancreas (AP) were compared with three days of parent-managed sensor-augmented pump (SAP).
RESULTS: Overnight time-in-hypoglycemia was reduced with the AP versus SAP, median (25(th)-75(th) percentiles): 0.0% (0.0-2.2) vs. 2.2% (0.0-12.3) (P = 0.002), without a significant change of time-in-target, mean: 56.0% (SD 22.5%) vs. 59.7% (21.2%) (P = 0.430), but with increased mean glucose 173 mg/dL (SD 36) vs. 150 mg/dL (SD 39) (P = 0.002). Overall, the AP granted a threefold reduction of time-in-hypoglycemia (P < 0.001) at the cost of decreased time-in-target, 56.8% (SD 13.5) vs. 63.1% (SD 11.0) (P = 0.022) and increased mean glucose 169 mg/dL (SD 23) vs. 147 mg/dL (SD 23) (P < 0.001).
CONCLUSIONS: This trial, the first outpatient single-hormone AP trial in a population of this age, shows feasibility and safety of MMPC in young children. Algorithm retuning will be performed to improve efficacy.

PMID: 27208335 [PubMed - as supplied by publisher]

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Day and Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home.

Day and Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home.

Diabetes Care. 2016 May 5;

Authors: Renard E, Farret A, Kropff J, Bruttomesso D, Messori M, Place J, Visentin R, Calore R, Toffanin C, Di Palma F, Lanzola G, Magni P, Boscari F, Galasso S, Avogaro A, Keith-Hynes P, Kovatchev B, Del Favero S, Cobelli C, Magni L, DeVries JH, AP@home Consortium

Abstract
OBJECTIVE: After testing of a wearable artificial pancreas (AP) during evening and night (E/N-AP) under free-living conditions in patients with type 1 diabetes (T1D), we investigated AP during day and night (D/N-AP) for 1 month.
RESEARCH DESIGN AND METHODS: Twenty adult patients with T1D who completed a previous randomized crossover study comparing 2-month E/N-AP versus 2-month sensor augmented pump (SAP) volunteered for 1-month D/N-AP nonrandomized extension. AP was executed by a model predictive control algorithm run by a modified smartphone wirelessly connected to a continuous glucose monitor (CGM) and insulin pump. CGM data were analyzed by intention-to-treat with percentage time-in-target (3.9-10 mmol/L) over 24 h as the primary end point.
RESULTS: Time-in-target (mean ± SD, %) was similar over 24 h with D/N-AP versus E/N-AP: 64.7 ± 7.6 vs. 63.6 ± 9.9 (P = 0.79), and both were higher than with SAP: 59.7 ± 9.6 (P = 0.01 and P = 0.06, respectively). Time below 3.9 mmol/L was similarly and significantly reduced by D/N-AP and E/N-AP versus SAP (both P < 0.001). SD of blood glucose concentration (mmol/L) was lower with D/N-AP versus E/N-AP during whole daytime: 3.2 ± 0.6 vs. 3.4 ± 0.7 (P = 0.003), morning: 2.7 ± 0.5 vs. 3.1 ± 0.5 (P = 0.02), and afternoon: 3.3 ± 0.6 vs. 3.5 ± 0.8 (P = 0.07), and was lower with D/N-AP versus SAP over 24 h: 3.1 ± 0.5 vs. 3.3 ± 0.6 (P = 0.049). Insulin delivery (IU) over 24 h was higher with D/N-AP and SAP than with E/N-AP: 40.6 ± 15.5 and 42.3 ± 15.5 vs. 36.6 ± 11.6 (P = 0.03 and P = 0.0004, respectively).
CONCLUSIONS: D/N-AP and E/N-AP both achieved better glucose control than SAP under free-living conditions. Although time in the different glycemic ranges was similar between D/N-AP and E/N-AP, D/N-AP further reduces glucose variability.

PMID: 27208331 [PubMed - as supplied by publisher]

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Deficiency of HTRA2/Omi is associated with infantile neurodegeneration and 3-methylglutaconic aciduria.

Deficiency of HTRA2/Omi is associated with infantile neurodegeneration and 3-methylglutaconic aciduria.

J Med Genet. 2016 May 12;

Authors: Mandel H, Saita S, Edvardson S, Jalas C, Shaag A, Goldsher D, Vlodavsky E, Langer T, Elpeleg O

Abstract
BACKGROUND: Cell survival critically depends on the integrity of mitochondria, which play a pivotal role during apoptosis. Extensive mitochondrial damage promotes release of pro-apoptotic factors from the intermembrane space of mitochondria. Released mitochondrial proteins include Smac/DIABLO and HTRA2/Omi, which inhibit the cytosolic E3 ubiquitin ligase XIAP and other inhibitors of apoptosis proteins.
AIMS: Here we investigated the cause of extreme hypertonia at birth, alternating with hypotonia, with the subsequent appearance of extrapyramidal symptoms, lack of psychomotor development, microcephaly, intractable seizures and early death in four patients from two unrelated families. The patients showed lactic acidemia, 3-methylglutaconic aciduria, intermittent neutropenia, evolving brain atrophy and disturbed cristae structure in muscle mitochondria.
METHODS AND RESULTS: Using whole-exome sequencing, we identified missplicing mutation and a 5 bp deletion in HTRA2, encoding HTRA2/Omi. This protein was completely absent from the patients' fibroblasts, whose growth was impaired and which were hypersensitive to apoptosis. Expression of HtrA2/Omi or of the proteolytically inactive HTRA2/Omi protein restored the cells' apoptotic resistance. However, cell growth was only restored by the proteolytically active protein.
CONCLUSIONS: This is the first report of recessive deleterious mutations in HTRA2 in human. The clinical phenotype, the increased apoptotic susceptibility and the impaired cell growth recapitulate those observed in the Htra2 knockout mice and in mutant mice with proteolytically inactive HTRA2/Omi. Together, they underscore the importance of both chaperone and proteolytic activities of HTRA2/Omi for balanced apoptosis sensitivity and for brain development. Absence of HTRA2/Omi is associated with severe neurodegenerative disorder of infancy, abnormal mitochondria, 3-methylglutaconic aciduria and increased sensitivity to apoptosis.

PMID: 27208207 [PubMed - as supplied by publisher]

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Quantitative Assessment of Left Ventricular Diastolic Stiffness Using Cardiac Shear Wave Elastography: A Pilot Study.

Quantitative Assessment of Left Ventricular Diastolic Stiffness Using Cardiac Shear Wave Elastography: A Pilot Study.

J Ultrasound Med. 2016 May 20;

Authors: Song P, Bi X, Mellema DC, Manduca A, Urban MW, Greenleaf JF, Chen S

Abstract
OBJECTIVES: The purpose of this study was to systematically investigate the feasible echocardiographic views for human transthoracic cardiac shear wave elastography (SWE) and the impact of myocardial anisotropy on myocardial stiffness measurements.
METHODS: A novel cardiac SWE technique using pulse inversion harmonic imaging and time-aligned sequential tracking was developed for this study. The technique can measure the quantitative local myocardial stiffness noninvasively. Ten healthy volunteers were recruited and scanned by the proposed technique 3 times on 3 different days.
RESULTS: Seven combinations of echocardiographic views and left ventricular (LV) segments were found to be feasible for LV diastolic stiffness measurements: basal interventricular septum under parasternal short- and long-axis views; mid interventricular septum under parasternal short- and long-axis views; anterior LV free wall under parasternal short- and long-axis views; and posterior LV free wall under a parasternal short-axis view. Statistical analyses showed good repeatability of LV diastolic stiffness measurements among 3 different days from 70% of the participants for the basal interventricular septum and posterior LV free wall short-axis views. On the same LV segment, the mean diastolic shear wave speed measurements from the short-axis view were statistically different from the long-axis measurements: 1.82 versus 1.29 m/s for the basal interventricular septum; 1.81 versus 1.45 m/s for mid interventricular septum; and 1.96 versus 1.77 m/s for the anterior LV free wall, indicating that myocardial anisotropy plays a substantial role in LV diastolic stiffness measurements.
CONCLUSIONS: These results establish the preliminary normal range of LV diastolic stiffness under different scan views and provide important guidance for future clinical studies using cardiac SWE.

PMID: 27208201 [PubMed - as supplied by publisher]

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Early to Dialyze

Acute kidney injury (AKI) among hospitalized patients is common, consequential, and costly. Annually in the United States, approximately 10% of the estimated 5 million hospitalizations are complicated by AKI, with 0.4% of cases severe enough to require dialysis. Among patients with AKI requiring extracorporeal kidney support (dialysis), in-hospital mortality rates are consistently in excess of 20%, and may exceed 40% when accompanied by nonrenal organ system failure. Acute kidney injury results in prolonged hospital stay, and is associated with marked increase in hospital costs, with attributable costs estimated to be between $5 billion and $10 billion annually. Moreover, AKI has been linked with increased longer-term risks of chronic kidney disease (CKD), another condition associated with poor outcomes and high health care resource consumption, as well as of higher risks of hypertension.

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Early vs Delayed RRT in Critically Ill Patients With AKI

This randomized clinical trial compares the effects of early vs delayed initiation of renal replacement therapy on 90-day all-cause mortality among critically ill patients with AKI.

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quality of care; +39 new citations

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