There are no published studies directly comparing the accuracy of continuous glucose monitoring (CGM) devices in the outpatient setting. We tested the performance of the Dexcom G5, Abbot Freestyle Libre Pro, and Senseonics Eversense (an implantable CGM approved in Europe) during a 6-week, free-living, outpatient bionic pancreas study involving 23 subjects with type 1 diabetes who wore all 3 devices concomitantly. The primary outcome was the mean absolute relative difference (MARD) vs. plasma glucose (PG) values measured with the Nova Biomedical StatStrip Xpress meter that was also used for calibrations according to the manufacturer's instruction (except for Libre Pro that is not calibrated). We compared PG values with CGM readings when they were available from all 3 CGMS in the 5 minutes preceding the PG values (n=829 sets). Since the Libre Pro records readings every 15 minutes, we also did a two-way comparison between the G5 and the Eversense that allowed a higher number of comparisons (n=2277 sets). Statistical significance was determined using a repeated measurements model fitted with the generalized estimating equation method. All 3 CGM systems produced higher average MARDs than during in-clinic studies. However, since all three CGM systems were worn by the same individuals and used the same meter for calibration and as comparator, we were able to directly compare their performance under real-world conditions. In the 3-way comparison Eversense achieved the lowest nominal MARD (14.8%) followed by Dexcom G5 (16.3%) and Libre Pro (18.0%) (Eversense vs. Libre Pro p=0.004, other comparisons p=NS). In the 2-way comparison the MARD difference between Eversense (15.1%) and G5 (16.9%) was statistically significant (p=0.008). We found that the point accuracy of the Eversense was significantly better than two other CGM systems. The Eversense CGM system may be useful to provide glucose values to artificial pancreas devices.
Disclosure
R.Z. Jafri: None. C.A. Balliro: None. F. El-Khatib: Stock/Shareholder; Self; Beta Bionics. Employee; Self; Beta Bionics. M. Maheno: None. M.A. Hillard: None. A.J. O'Donovan: None. R. Selagamsetty: None. H. Zheng: None. E. Damiano: Other Relationship; Self; Beta Bionics. S.J. Russell: Other Relationship; Self; Beta Bionics, Novo Nordisk Inc.. Advisory Panel; Self; Companion Medical, Tandem Diabetes Care, Inc., Unomedical a/s. Research Support; Self; Beta Bionics, Zealand Pharma A/S, MITRE Corporation.
The bihormonal bionic pancreas (BP) reduced both mean CGM glucose (CGMG) and time in the hypoglycemic range relative to usual care in outpatient studies. We recently performed an outpatient study in which we compared insulin-only (IOBP) and bihormonal (BHBP) configurations of the BP with usual care (UC; conventional or sensor-augmented insulin pump therapy) both with and without remote monitoring. We previously reported that monitoring did not affect the mean CGMG or hypoglycemia with either configuration of the BP. The current analysis focuses on the data collected from arms without remote monitoring (how the BP is eventually meant to be used) to determine how the effects of the BP differ between the day and night. As shown in the Table, both the IOBP (with glucose target of 110 mg/dl) and BHBP (with glucose target of 100 mg/dl) significantly reduced mean CGMG vs. UC during both the daytime and nighttime. In contrast, only the BHBP significantly reduced the percent of time spent with CGMG <60 mg/dl vs. UC. The BHBP similarly reduced percent of time <60 mg/dl vs. IOBP. The significant reductions in hypogycemia associated with the BHBP were driven primarily by reductions in hypoglycemia at night.
Disclosure
J. Sherwood: None. C.A. Balliro: None. R.Z. Jafri: None. F. El-Khatib: Stock/Shareholder; Self; Beta Bionics. Employee; Self; Beta Bionics. M. Maheno: None. M.A. Hillard: None. A.J. O'Donovan: None. R. Selagamsetty: None. H. Zheng: None. E. Damiano: Other Relationship; Self; Beta Bionics. S.J. Russell: Other Relationship; Self; Beta Bionics, Novo Nordisk Inc.. Advisory Panel; Self; Companion Medical, Tandem Diabetes Care, Inc., Unomedical a/s. Research Support; Self; Beta Bionics, Zealand Pharma A/S, MITRE Corporation.
In patients with post-traumatic stress disorder (PTSD), the use of coping mechanisms seems to correlate with higher levels of resiliency; however, in the age of the internet, patients may find it easier to discover new unhealthy skills that can hinder their treatment and further progress their symptoms. This report describes the case of a 12-year-old female with PTSD who was admitted for suicidal ideation and who presented with age regression that was voluntary in nature, characterized by reverting to the age of a sixyear-old girl while her boyfriend took on a parental role for her. These behaviors were learned through her use of social media. This case demonstrates the use of maladaptive behaviors to cope with their trauma and the need for parental supervision on the use of the internet and social media by the younger population.
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