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Dexcom G4 Platinum

Device Name:G4 Platinum
Manufacturer:Sole: Dexcom, 6340 Sequence Dr, San Diego, CA 92121, UNITED STATES.
Measuring functions:Blood glucose
Primary Client Use:Intended for both professional use and self-measurement
Measurement Site:Abdomen
Measurement Occurrence:Continuous measurement
Availability:Recalled
Description: The Dexcom G4 Platinum is a clinically validated blood glucose meter. Measurements are taken from the abdomen and it is intended for both professional use and self-measurement. DO NOT USE THIS DEVICE. It has been recalled by the manufacturer. Please check with your supplier or the manufacturer for further details.
Assessment:

The technology used in the Dexcom G4 Platinum, to measure blood glucose, has been assessed, in general and specific populations, according to non-standard protocols.

Accuracy AssessmentRecommendationBasis
MedavalNoneWhen an evaluation is carried out using a non-standard protocol, no inference can be made on accuracy based on a standard protocol.

Validation Publications

Bailey TS, Chang A, Christiansen M. Clinical accuracy of a continuous glucose monitoring system with an advanced algorithm. J Diabetes Sci Technol. 2015 Mar;9(2):209-14. Epub: 2014 Nov 3. doi: 10.1177/1932296814559746. PMID: 25370149. Available from: PMC4604574.

Ad Hoc protocol General population

The authors concluded that the device was superior to other CGM systems at that time.

Nakamura K, Balo A. The Accuracy and Efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System. J Diabetes Sci Technol. 2015 Mar 23;9(5):1021-6. doi: 10.1177/1932296815577812. PMID: 25802469. Available from: PMC4667335.

Ad Hoc protocol General population

The authors concluded that the device was one of the most accurate CGM systems at that time.

Bally L, Zueger T, Pasi N, Carlos C, Paganini D, Stettler C. Accuracy of continuous glucose monitoring during differing exercise conditions. Diabetes Res Clin Pract. 2016 Feb;112:1-5. Epub: 2015 Dec 19. doi: 10.1016/j.diabres.2015.11.012. PMID: 26739116.

Ad Hoc protocol Men with controlled T1DM (n=10)

The authors concluded that the device revealed good and comparable accuracy during intermittent high intensity and continuous moderate intensity exercise.

Laffel L. Improved Accuracy of Continuous Glucose Monitoring Systems in Pediatric Patients with Diabetes Mellitus: Results from Two Studies. Diabetes Technol Ther. 2016 Feb;18(Suppl 2):S223-33. doi: 10.1089/dia.2015.0380. PMID: 26784126. Available from: PMC4717517.

Ad Hoc protocol 176 children and adolescents with T1DM [1 with T2DM] (aged 2 to 17 years) (Note: The older "continuous glucose monitoring" algorithm was used. The J&J LifeScan OneTouch Verio IQ was used for self monitoring.)

Ad Hoc protocol 79 children and adolescents with T2DM (aged 2 to 17 years) (Note: The newer "Software 505" algorithm was used. The Bayer Contour Next USB was used for self monitoring.)

The authors concluded that the newer "Software 505" algorithm offered substantial improvements in accuracy and performance in pediatric patients with diabetes. This was in both YSI comparisons and comparisons with the respective self-monitoring devices.

Relevant Publications

Pleus S, Schmid C, Link M, Zschornack E, Klötzer HM, Haug C, Freckmann G. Performance evaluation of a continuous glucose monitoring system under conditions similar to daily life. J Diabetes Sci Technol. 2013 Jul 1. 833-41 p. doi: 10.1177/193229681300700405. PMID: 23911164. Available from: PMC3879747.

The publication evaluates the performance of the Dexcom G4 Platinum, though not in a formal validation.

Matuleviciene V, Joseph JI, Andelin M, Hirsch IB, Attvall S, Pivodic A, Dahlqvist S, Klonoff D, Haraldsson B, Lind M. 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. Diabetes Technol Ther. 2014 Nov;16(11):759-67. Epub: 2014 Sep 18. doi: 10.1089/dia.2014.0238. PMID: 25233297. Available from: PMC4201312.

Measurements from the Dexcom G4 Platinum are compared to those from Medtronic Enlite, though not in a formal validation.

The authors concluded that patients had a more positive treatment experience with the Dexcom G4 system and that it showed greater accuracy than the Medtronic Enlite system.

Kropff J, Bruttomesso D, Doll W, Farret A, Galasso S, Luijf YM, Mader JK, Place J, Boscari F, Pieber TR, Renard E, DeVries JH. Accuracy of two continuous glucose monitoring systems: a head-to-head comparison under clinical research centre and daily life conditions. Diabetes Obes Metab. 2015 Apr;17(4):343-9. Epub: 2014 Sep 10. doi: 10.1111/dom.12378. PMID: 25132320. Available from: PMC4409843.

Measurements from the Dexcom G4 Platinum are compared to those from the Medtronic Enlite, though not in a formal validation.

van Beers CA, DeVries JH. Analysis: The Accuracy and Efficacy of the Dexcom G4 Platinum Continuous Glucose Monitoring System. J Diabetes Sci Technol. 2015 Apr 27;9(5):1027-9. doi: 10.1177/1932296815583508. PMID: 25917336. Available from: PMC4667343.

The publication is a letter or correspondence in which the Dexcom G4 Platinum is referenced.

See J Diabetes Sci Technol. 2015 Mar 23;9(5):1021-1026.

Pariente Rodrigo E, Deib-Morgan K, García de Diego O, García-Velasco P, Sgaramella GA García González I Accuracy and reliability between glucose meters: A study under normal clinical practice conditions Semergen. 2017 Jan;43(1):20-27. Epub: 2016. doi: 10.1016/j.semerg.2016.01.011. PMID: 26968861.

Measurements from the Dexcom G4 Platinum are compared to those from the Abbott FreeStyle Libre (Flash), though not in a formal validation.

The authors concluded that there was good agreement between the devices.

Andelin M, Kropff J, Matuleviciene V, Joseph JI, Attvall S, Theodorsson E, Hirsch IB, Imberg H, Dahlqvist S, Klonoff D, Haraldsson B, DeVries JH, Lind M. Assessing the Accuracy of Continuous Glucose Monitoring (CGM) Calibrated With Capillary Values Using Capillary or Venous Glucose Levels as a Reference. J Diabetes Sci Technol. 2016 Jun 28;10(4):876-84. doi: 10.1177/1932296815626724. PMID: 26810924. Available from: PMC4928217. Print 2016 Jul.

The authors concluded that, when assessing the accuracy of CGM devices, it is essential to use the same type of sample for both calibration and reference purposes, as glucose levels from capillary samples are significantly higher than those from venous samples in all glycemic ranges.

Taleb N, Emami A, Suppere C, Messier V, Legault L, Chiasson JL, Rabasa-Lhoret R, Haidar A. Comparison of Two Continuous Glucose Monitoring Systems, Dexcom G4 Platinum and Medtronic Paradigm Veo Enlite System, at Rest and During Exercise. Diabetes Technol Ther. 2016 Sep;18(9):561-7. Epub: 2016 Jun 29. doi: 10.1089/dia.2015.0394. PMID: 27356172.

Measurements from the Dexcom G4 Platinum are compared to those from the Medtronic Enlite, though not in a formal validation.

The authors concluded that the device performances were comparable during rest and physical activity but required a fine-tuning during activity due to lower accuracy.

Boscari F, Galasso S, Facchinetti A, Marescotti MC, Vallone V, Amato AML, Avogaro A, Bruttomesso D. FreeStyle Libre and Dexcom G4 Platinum sensors: Accuracy comparisons during two weeks of home use and use during experimentally induced glucose excursions. Nutr Metab Cardiovasc Dis. 2018 Feb;28(2):180-6. Epub: 2017 Nov 11. doi: 10.1016/j.numecd.2017.10.023. PMID: 29258716.

Measurements from the Dexcom G4 Platinum are compared to those from the Abbott FreeStyle Libre (Flash), though not in a formal validation.

The authors concluded that both devices performed similarly for 2 weeks (manufacturer-specified lifetime for the Libre; double that lifetime for the G4) but that both performed less well during hypoglycaemia with the Libre beings more accurate during glucose swings.

Vandersluis S, Kabali C, Djalalov S, Gajic-Veljanoski O, Wells D and Holubowich C on behalf of Health Quality Ontario. Continuous Monitoring of Glucose for Type 1 Diabetes: A Health Technology Assessment. Ont Health Technol Assess Ser. 2018 Feb 21;18(2):1-160. PMID: 29541282. Available from: PMC5836597. eCollection 2018.

The publication describes the use of the Dexcom G4 Platinum in a scientific study.

Steineck IIK, Mahmoudi Z, Ranjan A, Schmidt S, Jørgensen JB, Nørgaard K. Comparison of Continuous Glucose Monitoring Accuracy Between Abdominal and Upper Arm Insertion Sites. Diabetes Technol Ther. 2019 May;21(5):295-302. Epub: 2019 Apr 17. doi: 10.1089/dia.2019.0014. PMID: 30994362. Available from: www.liebertpub.com.

The accuracy of a Dexcom G4 Platinum CGM sensor placed on the upper arm was not different from the accuracy of the sensor placed on the abdomen in adults with type 1 diabetes.

Yingling L, Allen NA, Litchman ML, Colicchio V, Gibson BS. An Evaluation of Digital Health Tools for Diabetes Self-Management in Hispanic Adults: Exploratory Study. JMIR Diabetes. 2019 Jul 16;4(3):e12936. doi: 102196/12936. PMID: 31313657. Available from: PMC6664655.

Sensor-based tools for facilitating T2DM self-monitoring appear to be a feasible and acceptable technology among low-income Hispanic adults. Barriers to acceptability and preferences for wearable sensor integration in a community-based intervention are identified. The findings have implications for the design of T2DM interventions targeting Hispanic adults.