Literature DB >> 34889119

Clinical Study of a High Accuracy Green Design Blood Glucose Monitor Using an Innovative Optical Transmission Absorbance System.

Takeyuki Moriuchi1, Yuto Otaki1, Hiroya Satou1, Fumihiko Chai1, Yuma Hayashida1, Ryokei Aikawa1, Takayuki Sugiyama1, Koji Sode2.   

Abstract

BACKGROUND: Blood glucose monitoring (BGM) is essential for glycemic control in diabetic therapy. Followingly, accurate sensors are required for both daily personal and clinical use. The frequency of sensor use in patients with diabetes facilitates the use of disposable components. However, BGM systems are not exempt from green innovation sustainability initiatives.
METHODS: Clinical study of a high-accuracy green design blood glucose monitor using an innovative optical transmission absorbance system was carried out. Venous blood samples were collected from 104 patients with type II diabetes. The heat resistance of sensor strips was evaluated by storing sensor strips at 25℃ and 60℃ for approximately 3 months. Accuracy of the BGM system was evaluated via the ISO 15197:2013 protocol.
RESULTS: The BGM system achieved ±7.1% accuracy in glycemic level measurement, with 84% of all measurements within ±5% of the reference values. Furthermore, the sensor strip demonstrated heat resistance for more than 3 months when stored at 60℃.
CONCLUSIONS: A new, highly accurate BGM system was developed based on the latest optical measurement system, introducing a rare metal-free "green-strip." The developed BGM system achieved the highest reported accuracy in clinical research, using venous blood from patients with diabetes. The sensor strip also exhibited high heat resistance, reducing limitations on storage conditions.

Entities:  

Keywords:  accuracy; blood glucose monitoring; green design; green diabetes initiative; optical BGM

Mesh:

Substances:

Year:  2021        PMID: 34889119      PMCID: PMC9445325          DOI: 10.1177/19322968211060865

Source DB:  PubMed          Journal:  J Diabetes Sci Technol        ISSN: 1932-2968


  27 in total

1.  Analysis of the environmental impact of insulin infusion sets based on loss of resources with waste.

Authors:  Andreas Pfützner; Petra B Musholt; Bjoern Malmgren-Hansen; Nils H Nilsson; Thomas Forst
Journal:  J Diabetes Sci Technol       Date:  2011-07-01

2.  The Effects of Temperature and Relative Humidity on Point-of-Care Glucose Measurements in Hospital Practice in a Tropical Clinical Setting.

Authors:  Busadee Pratumvinit; Nattakom Charoenkoop; Soamsiri Niwattisaiwong; Gerald J Kost; Panutsaya Tientadakul
Journal:  J Diabetes Sci Technol       Date:  2016-08-22

3.  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.

Authors:  David C Klonoff
Journal:  J Diabetes Sci Technol       Date:  2019-04-11

4.  The Diabetes Technology Society Green Diabetes Initiative.

Authors:  David C Klonoff; Lutz Heinemann; Curtiss B Cook; Bithika M Thompson; David Kerr; Julia Han; Edward P Krisiunas
Journal:  J Diabetes Sci Technol       Date:  2020-02-05

5.  Accuracy Evaluation of a New System for Self-Monitoring of Blood Glucose With Three Test Strip Lots Based on ISO 15197:2013.

Authors:  Annette Baumstark; Nina Jendrike; Stefan Pleus; Christina Liebing; Cornelia Haug; Guido Freckmann
Journal:  J Diabetes Sci Technol       Date:  2017-09-21

6.  Accuracy of blood glucose meters for self-monitoring affects glucose control and hypoglycemia rate in children and adolescents with type 1 diabetes.

Authors:  Claudia Boettcher; Axel Dost; Stefan A Wudy; Marion Flechtner-Mors; Martin Borkenstein; Ralf Schiel; Dieter Weitzel; Susanne Bechtold-Dalla Pozza; Johannes Wolf; Reinhard W Holl
Journal:  Diabetes Technol Ther       Date:  2014-12-30       Impact factor: 6.118

7.  Effect of BGM Accuracy on the Clinical Performance of CGM: An In-Silico Study.

Authors:  Enrique Campos-Náñez; Marc D Breton
Journal:  J Diabetes Sci Technol       Date:  2017-05-31

8.  Accuracy Beyond ISO: Introducing a New Method for Distinguishing Differences Between Blood Glucose Monitoring Systems Meeting ISO 15197:2013 Accuracy Requirements.

Authors:  Scott Pardo; Rimma M Shaginian; David A Simmons
Journal:  J Diabetes Sci Technol       Date:  2018-03-15

9.  Continuous Glucose Monitoring (CGM) or Blood Glucose Monitoring (BGM): Interactions and Implications.

Authors:  Lutz Heinemann
Journal:  J Diabetes Sci Technol       Date:  2018-04-12

Review 10.  Glucose Sensing for Diabetes Monitoring: Recent Developments.

Authors:  Danielle Bruen; Colm Delaney; Larisa Florea; Dermot Diamond
Journal:  Sensors (Basel)       Date:  2017-08-12       Impact factor: 3.576

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  2 in total

1.  Diabetes Technology Meeting 2021.

Authors:  Nicole Y Xu; Kevin T Nguyen; Ashley Y DuBord; John Pickup; Jennifer L Sherr; Hazhir Teymourian; Eda Cengiz; Barry H Ginsberg; Claudio Cobelli; David Ahn; Riccardo Bellazzi; B Wayne Bequette; Laura Gandrud Pickett; Linda Parks; Elias K Spanakis; Umesh Masharani; Halis K Akturk; John S Melish; Sarah Kim; Gu Eon Kang; David C Klonoff
Journal:  J Diabetes Sci Technol       Date:  2022-05-02

2.  Clinical Study of a High Accuracy Green Design Blood Glucose Monitor Using an Innovative Optical Transmission Absorbance System.

Authors:  Takeyuki Moriuchi; Yuto Otaki; Hiroya Satou; Fumihiko Chai; Yuma Hayashida; Ryokei Aikawa; Takayuki Sugiyama; Koji Sode
Journal:  J Diabetes Sci Technol       Date:  2021-12-10
  2 in total

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