Cross‐over trials in <i>Statistics in Medicine</i>: the first ‘25’ years

Senn, Stephen

doi:10.1002/sim.2706

Cited by 84 publications

(91 citation statements)

References 54 publications

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“…Normally distributed data are reported as mean (SD) and nonnormally distributed as median (25th-75th percentile). A post hoc analysis investigating the existence of carryover was performed as previously published (9). If a carryover was found (P , 0.05), data of the second period were discarded (9).…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2016

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OBJECTIVEThe Pediatric Artificial Pancreas (PedArPan) project tested a children-specific version of the modular model predictive control (MMPC) algorithm in 5-to 9-yearold children during a camp. RESEARCH DESIGN AND METHODSA 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 sensoraugmented pump (SAP). RESULTSOvernight 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 5 0.002), without a significant change of time-in-target, mean: 56.0% (SD 22.5) vs. 59.7% (21.2) (P 5 0.430), but with increased mean glucose 173 mg/dL (36) vs. 150 mg/dL (39) (P 5 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% (13.5) vs. 63.1% (11.0) (P 5 0.022) and increased mean glucose 169 mg/dL (23) vs. 147 mg/dL (23) (P < 0.001). CONCLUSIONSThis 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.Only three artificial pancreas (AP) trials have focused on the prepubertal population so far: two single-hormone AP studies, performed inpatient for less than 1 day (1,2) and a recent dual-hormone AP study, performed in a camp for 5 days (3). Here we report the first outpatient single-hormone AP trial focusing on 5-to 9-year-old children.Data were collected in the Pediatric Artificial Pancreas (PedArPan) camp, where sensor-augmented pump (SAP) therapy was compared with the modular model predictive control algorithm (MMPC) (4,5), running on the wearable platform Diabetes Assistant (DiAs) (6).

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Section: Methodsmentioning

confidence: 99%

“…A post hoc analysis investigating the existence of carryover was performed as previously published (9). If a carryover was found (P , 0.05), data of the second period were discarded (9). Unless otherwise stated, no carryover or period effect was found.…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2016

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“…Point estimates and 95% confidence intervals (CIs) for the difference (Δ) between 2 outcomes are provided using the Hodges-Lehmann procedure. 25,26 The MARD of the Dexcom G4 analyzed in relation to venous and capillary reference glucose values as a continuous function of glucose levels was performed by fitting a second-order spline. Analyses were performed using SAS version 9.3 (SAS, Inc, Cary, NC).…”

Section: Statisticsmentioning

confidence: 99%

Assessing the Accuracy of Continuous Glucose Monitoring (CGM) Calibrated With Capillary Values Using Capillary or Venous Glucose Levels as a Reference

Andelin

Kropff

Matuleviciene

et al. 2016

J Diabetes Sci Technol

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Background: Using the standard venous reference for the evaluation of continuous glucose monitoring (CGM) systems could possibly negatively affect measured CGM accuracy since CGM are generally calibrated with capillary glucose and venous and capillary glucose concentrations differ. We therefore aimed to quantify the effect of using capillary versus venous glucose reference samples on estimated accuracy in capillary calibrated CGM. Methods:We evaluated 41 individuals with type 1 diabetes mellitus (T1DM) using the Dexcom G4 CGM system over 6 days. Patients calibrated their CGM devices with capillary glucose by means of the HemoCue system. During 2 visits, capillary and venous samples were simultaneously measured by HemoCue and compared to concomitantly obtained CGM readings. The mean absolute relative difference (MARD) was calculated using capillary and venous reference samples. Results:Venous glucose values were 0.83 mmol/L (15.0 mg/dl) lower than capillary values over all glycemic ranges, P < .0001. Below 4 mmol/l (72 mg/dl), the difference was 1.25 mmol/l (22.5 mg/dl), P = .0001, at 4-10 mmol/l (72-180 mg/dl), 0.67 mmol/l (12.0 mg/dl), P < .0001 and above 10 mmol/l (180 mg/dl), 0.95 mmol/l (17.1 mg/dl), P < .0001. MARD was 11.7% using capillary values as reference compared to 13.7% using venous samples, P = .037. Below 4 mmol/l (72 mg/dl) MARD was 16.6% and 31.8%, P = .048, at 4-10 mmol/l (72-180 mg/dl) 12.1% and 12.6%, P = .32, above 10 mmol/l (180 mg/dl) 8.7% and 9.2%, P = .82. Conclusion:Using capillary glucose concentrations as reference to evaluate the accuracy of CGM calibrated with capillary samples is associated with a lower MARD than using venous glucose as the reference. Capillary glucose concentrations were significantly higher than venous in all glycemic ranges.

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“…A balanced cross-over design was chosen (37). The study consisted of three sessions with an interval between for each participant ( Figure 1).…”

Section: Designmentioning

confidence: 99%

No effects of MRI scan on male reproduction hormones

Mollerlokken

Moen

Baste

et al. 2012

Reproductive Toxicology

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This is an accepted version of a paper published in Reproductive Toxicology. This paper has been peer-reviewed but does not include the final publisher proof-corrections or journal pagination.Citation for the published paper: Møllerløkken, O., Moen, B., Baste, V., Magerøy, N., Oftedal, G. et al. (2012) "No effects of MRI scan on male reproduction hormones." Reproductive Toxicology URL: http://dx.doi.org/10. 1016/j.reprotox.2012.04.003 Access to the published version may require subscription. A prospective randomized balanced cross-over study using a head scan in real MRI with whole-body transmitting coil and sham MRI among 24 healthy male volunteers was conducted. Serum-blood samples of inhibin B, testosterone, prolactine, thyreotropine, luteinizing hormone, follicle stimulating hormone, sex-hormone binding globuline and estradiol were taken before and after the different scans. Neither immediately after, nor after 11 days were there seen any differences in the hormone levels comparing real and sham MRI. The lack of effects of EMF on male reproductive hormones should be reassuring to the public and especially for men examined in MRI. Adverse effects on other endpoints than male reproduction or possible chronic effect of multiple MRI scans have not been investigated in this study. Abstract (150 words)The use of mMagnetic resonance imaging (MRI) is increasing around the world and the possible adverse effects on reproductive health of electromagnetic fields (EMF) in MRI are not previously studied. We conducted aA prospective randomized balanced cross-over study using a head scan in real MRI with whole-body transmitting coil and sham MRI scan among 24 healthy male volunteers was conducted. Serum-blood samples of inhibin B, testosterone, prolactine, thyreotropine, luteinizing hormone, follicle stimulating hormone, sex-hormone binding globuline and estradiol were taken before and after the different scans. Neither immediately after, nor after 11 days were there seen any differences in the hormone levels comparing real and sham MRI. The lack of effects of EMF on male reproductive hormones should be reassuring to the public and especially for men examined in MRI. Adverse effects on other endpoints than male reproduction or possible chronic effect of multiple MRI scans have not been investigated in this study. Your reviewers have given us valuable comments which my coauthors and I hope to have addressed properly in this letter and in the revised manuscript. We have described our response in the letter and given reference to where in the revised manuscript the changes are. We have also highlighted the changed text in the revised manuscript.We hope you will consider this revised manuscript. Do not hesitate to contact me if anything is unclear. Thank you. Yours sincerelyOle Jacob Møllerløkken Institute of Public Health and Primary Health CareUniversity of Bergen Bergen -Norway *Response to Reviewer CommentsReviewer #1:This is an interesting manuscript with relevance to human patients. The authors conducted a randomized...

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Cross‐over trials in Statistics in Medicine: the first ‘25’ years

Cited by 84 publications

References 54 publications

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

Assessing the Accuracy of Continuous Glucose Monitoring (CGM) Calibrated With Capillary Values Using Capillary or Venous Glucose Levels as a Reference

No effects of MRI scan on male reproduction hormones

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