Dataset Information

A clinical trial of the accuracy and treatment experience of the Dexcom G4 sensor (Dexcom G4 system) and Enlite sensor (guardian REAL-time system) tested simultaneously in ambulatory patients with type 1 diabetes.

ABSTRACT: Continuous glucose monitoring (CGM) is a tool widely used in the treatment of patients with type 1 diabetes. The purpose of the current study was to evaluate whether accuracy and patient treatment satisfaction differ between the Enlite™ (Medtronic MiniMed, Inc., Northridge, CA) and Dexcom(®) (San Diego, CA) G4 PLATINUM CGM sensors.Thirty-eight ambulatory patients with type 1 diabetes used the Dexcom G4 and Enlite sensors simultaneously for a minimum of 4 and maximum of 6 days. Patients measured capillary glucose levels with a HemoCue(®) (Ängelholm, Sweden) system six to 10 times a day. In addition, two inpatient studies were performed between Days 1-3 and 4-6.The mean absolute relative difference (MARD) in blood glucose for the Dexcom G4 was significantly lower (13.9%) than for the Enlite sensor (17.8%) (P<0.0001). The corresponding MARDs for Days 1-3 were 15.0% versus 19.4% (P=0.0027) and 13.6% versus 15.9% (P=0.026) for Days 4-6. For glucose levels in the hypoglycemic range (<4.0?mmol/L), the MARD for the Dexcom G4 was 20.0% compared with 34.7% for the Enlite (P=0.0041). On a visual analog scale (VAS) (0-100), patients rated the Dexcom G4 more favorably than the Enlite in 12 out of the 13 user experience questions. For example, more patients rated their experience with the Dexcom G4 as positive (VAS, 79.7 vs. 46.6; P<0.0001) and preferred to use it in their daily lives (VAS, 79.1 vs. 42.1; P<0.0001).The Dexcom G4 sensor was associated with greater overall accuracy than the Enlite sensor during initial (Days 1-3) and later (Days 4-6) use and for glucose levels in the hypoglycemic range. Patients reported a significantly more positive experience using the Dexcom G4 than the Enlite.

SUBMITTER: Matuleviciene V

PROVIDER: S-EPMC4201312 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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A clinical trial of the accuracy and treatment experience of the Dexcom G4 sensor (Dexcom G4 system) and Enlite sensor (guardian REAL-time system) tested simultaneously in ambulatory patients with type 1 diabetes.

Matuleviciene Viktorija V Joseph Jeffrey I JI Andelin Mervi M Hirsch Irl B IB Attvall Stig S Pivodic Aldina A Dahlqvist Sofia S Klonoff David D Haraldsson Börje B Lind Marcus M

Diabetes technology & therapeutics 20140918 11

<h4>Background</h4>Continuous glucose monitoring (CGM) is a tool widely used in the treatment of patients with type 1 diabetes. The purpose of the current study was to evaluate whether accuracy and patient treatment satisfaction differ between the Enlite™ (Medtronic MiniMed, Inc., Northridge, CA) and Dexcom(®) (San Diego, CA) G4 PLATINUM CGM sensors.<h4>Subjects and methods</h4>Thirty-eight ambulatory patients with type 1 diabetes used the Dexcom G4 and Enlite sensors simultaneously for a minimu ...[more]

PMID: 25233297

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Project description:Background: Safety and significant improvement in overall glycated hemoglobin (A1C) and percentage of time spent in (TIR), below (TBR), and above (TAR) glucose range were demonstrated in the pivotal trial of adolescents and adults using the MiniMed™ advanced hybrid closed-loop (AHCL) system with the adjunctive, calibration-required Guardian™ Sensor 3. The present study evaluated early outcomes of continued access study (CAS) participants who transitioned from the pivotal trial investigational system to the approved MiniMed™ 780G system with the non-adjunctive, calibration-free Guardian™ 4 Sensor (MM780G+G4S). Study data were presented alongside those of real-world MM780G+G4S users from Europe, the Middle East, and Africa. Methods: The CAS participants (N = 109, aged 7-17 years and N = 67, aged >17 years) used the MM780G+G4S for 3 months and data of real-world MM780G+G4S system users (N = 10,204 aged ≤15 years and N = 26,099 aged >15 years) were uploaded from September 22, 2021 to December 02, 2022. At least 10 days of real-world continuous glucose monitoring (CGM) data were required for analyses. Glycemic metrics, delivered insulin and system use/interactions underwent descriptive analyses. Results: Time in AHCL and CGM use were >90% for all groups. AHCL exits averaged 0.1/day and there were few blood glucose measurements (BGMs) (0.8/day-1.0/day). Adults in both cohorts met most consensus recommendations for glycemic targets. Pediatric groups met recommendations for %TIR and %TBR, although not those for mean glucose variability and %TAR, possibly due to low use of recommended glucose target (100 mg/dL) and active insulin time (2 h) settings (28.4% in the CAS cohort and 9.4% in the real-world cohort). The CAS pediatric and adult A1C were 7.2% ± 0.7% and 6.8% ± 0.7%, respectively, and there were no serious adverse events. Conclusions: Early clinical use of the MM780G+G4S was safe and involved minimal BGMs and AHCL exits. Consistent with real-world pediatric and adult use, outcomes were associated with achievement of recommended glycemic targets. Clinical Trial Registration number: NCT03959423.

Project description:Heat stress causes significant economic losses by reducing the productivity and welfare of cattle whilst requiring a significant investment in resource for amelioration. Panting score (PS) is considered a robust indicator of cattle heat stress; however, individualised visual monitoring is impractical. Thermal index-based monitoring and mitigation decisions are applied at the herd level, but they have limited application for the individual animal. As such, an automated system to monitor the real-time animal response to heat stress is required for strategic mitigation. Our objectives were to validate an accelerometer-based ear tag sensor to monitor cattle panting and to determine individual variability in heat stress responses with reference to thermal indices. Two experiments were conducted: Experiment 1 validated the sensors, and Experiment 2 determined individual variability comparing sensor data against thermal indices. Ear tag sensors were fitted at feedlot entry to continuously monitor the behaviour of 100 steers of mixed breed in Experiment 1 and 200 steers and heifers of mixed breed in Experiment 2. Sensor-derived 'heavy breathing' was validated against visually observed PS. Sensor-derived behaviour bouts were analysed as 'raw', and single behaviour states were also converted to the preceding bout of ?2 min, which was referred to as 'fill' data for the validation study. Our results demonstrate the sensors' ability to accurately monitor panting in feedlot cattle. Sensor-recorded 'heavy breathing' duration per animal was highly correlated to observed panting duration for both raw (r = 0.89) and fill (r = 0.90) data; however, the concordance correlation co-efficient was lower for raw (0.45) as compared with fill (0.76). Predicted agreement for raw data were 75%, 45%, and 68% and predicted agreement for fill data were 65%, 54%, and 83% for PS0, PS1, and PS2, respectively. Sensitivity for raw data were 39%, 37%, and 45% and for fill data, they were 59%, 54% and 82% for all PS data, PS1 and PS2, respectively. Specificity and positive predictive values for both raw (77% and 79%, respectively) and fill (65% and 77%, respectively) data show the probability of reporting false positives by sensors to be low. Experiment 2 revealed that the duration of panting increased from 0800 to 1700 h alongside changes in thermal indices with significant differences between and within breed and coat colour categories of cattle, suggesting that grouping and allocating heat amelioration measures by breed and coat colour can be effective in commercial feedlots. However, there was high variability (CV > 80%) in the duration of panting between individuals within the same breed and same coat colour, revealing the potential for strategic management at an individual level, and with the same data, genetic selection for heat resilience.

Dataset Information

A clinical trial of the accuracy and treatment experience of the Dexcom G4 sensor (Dexcom G4 system) and Enlite sensor (guardian REAL-time system) tested simultaneously in ambulatory patients with type 1 diabetes.

Publications

A clinical trial of the accuracy and treatment experience of the Dexcom G4 sensor (Dexcom G4 system) and Enlite sensor (guardian REAL-time system) tested simultaneously in ambulatory patients with type 1 diabetes.

Similar Datasets

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