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Entra MyGlucoHealth (MGH-BT1)
Device Name:
MyGlucoHealth
Device Model:
MGH-BT1
Manufacturer:
Entra Health Systems, Suite 101, 3111 Camino del Rio North, San Diego, California 92108, UNITED STATES.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger and general Alternative Site Testing
Measurement Occurrence:
Single measurements only
Connected Health Technologies:
Bluetooth
Availability:
Available Currently
Description:
The Entra MyGlucoHealth (MGH-BT1) is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 2-star Medaval rating. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for self-measurement and home use.
Assessment:
The technology used in the Entra MyGlucoHealth (MGH-BT1), to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval ★★ Recommendation Recent clinical validation; recent protocol
BG Institute of Health Economics (CA) General use No evidence provided
BG MDR Criteria Self-measurement Published evidence
Validation Publications:

Hasslacher C, Kulozik F, Platten I. Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting. J Diabetes Sci Technol. 2014 May;8(3):466-72. Epub: 2014 Feb 18. doi: 10.1177/1932296814522804. PMID: 24876607. Available from: PMC4455429.

15197:2013 - Fail General population

Pfützner A, Demircik F, Kirsch V, Pfützner J, Strobl S, Hanna M, Spatz J, Pfützner AH. System Accuracy Assessment of a Blood Glucose Meter With Wireless Internet Access Associated With Unusual Hypoglycemia Patterns in Clinical Trials. J Diabetes Sci Technol. 2019 May;13(3):507-513. Epub: 2019 Apr 11. doi: 10.1177/1932296819841353. PMID: 30974985. Available from: PMC6501533.

15197:2013 - Fail General population

See: J Diabetes Sci Technol. 2019 May;13(3):419-423.

Demircik F, Kirsch V, Ramljak S, Vogg M, Pfützner AH, Pfützner A. Laboratory Evaluation of Linearity, Repeatability, and Hematocrit Interference With an Internet-Enabled Blood Glucose Meter. J Diabetes Sci Technol. 2019 May;13(3):514-521. Epub: 2019 Apr 11. doi: 10.1177/1932296819841357. PMID: 30974988. Available from: PMC6501519.

15197:2013 - Pass General population (Note: Despite the overall pass, it failed the criteria for BG < 100 mg/dL (5.55 mmol/L) and failed the hematocrit interference criteria for BG ≥ 100 mg/dL (5.55 mmol/L).)

Relevant Publications:

Klonoff DC. Postmarket Surveillance of Blood Glucose Monitor Systems Is Needed for Safety of Subjects and Accurate Determination of Effectiveness in Clinical Trials of Diabetes Drugs and Devices. J Diabetes Sci Technol. 2019 May;13(3):419-423. Epub: 2019 Apr 11. doi: 10.1177/1932296819843398. PMID: 30974987. Available from: PMC6501534.

The publication is a letter or correspondence in which the Entra MyGlucoHealth is referenced.

See: J Diabetes Sci Technol. 2019 May;13(3):507-513.

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