Literature DB >> 28654305

Commentary Regarding Shapiro, "Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe?"

David Price1.   

Abstract

The FDA recently expanded the approved use of Dexcom's G5 Mobile continuous glucose monitoring (CGM) system to allow for diabetes treatment decisions. This decision is expected to reduce the burden of SMBG testing and increase the adoption and persistent use of CGM. The safety of nonadjunctive CGM use was questioned because of sporadic large discrepancies between CGM and SMBG values. These data were viewed in the context of complaints found in the FDA MAUDE database and social media postings. This commentary provides additional perspective on the inferences that can be drawn from these reports and the risk of nonadjunctive use of CGM data.

Entities:  

Keywords:  FDA decisions; continuous glucose monitoring; nonadjunctive use; self-monitored blood glucose

Mesh:

Substances:

Year:  2017        PMID: 28654305      PMCID: PMC5588837          DOI: 10.1177/1932296817695341

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


  12 in total

1.  Current state of type 1 diabetes treatment in the U.S.: updated data from the T1D Exchange clinic registry.

Authors:  Kellee M Miller; Nicole C Foster; Roy W Beck; Richard M Bergenstal; Stephanie N DuBose; Linda A DiMeglio; David M Maahs; William V Tamborlane
Journal:  Diabetes Care       Date:  2015-06       Impact factor: 19.112

2.  FDA Advisory Panel Votes to Recommend Non-Adjunctive Use of Dexcom G5 Mobile CGM.

Authors: 
Journal:  Diabetes Technol Ther       Date:  2016-07-29       Impact factor: 6.118

3.  Regulation Catches Up to Reality.

Authors:  Steven V Edelman
Journal:  J Diabetes Sci Technol       Date:  2016-09-25

4.  Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe?

Authors:  Alan R Shapiro
Journal:  J Diabetes Sci Technol       Date:  2017-03-01

5.  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

6.  HOW PATIENTS WITH TYPE 1 DIABETES TRANSLATE CONTINUOUS GLUCOSE MONITORING DATA INTO DIABETES MANAGEMENT DECISIONS.

Authors:  Jeremy Pettus; David A Price; Steven V Edelman
Journal:  Endocr Pract       Date:  2015-02-25       Impact factor: 3.443

7.  Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197: 2013 Accuracy Criteria, Consensus and Surveillance Error Grid Analyses, and Insulin Dosing Error Modeling in a Hospital Setting.

Authors:  José Luis Bedini; Jane F Wallace; Scott Pardo; Thorsten Petruschke
Journal:  J Diabetes Sci Technol       Date:  2015-10-07

Review 8.  Recommendations for Using Real-Time Continuous Glucose Monitoring (rtCGM) Data for Insulin Adjustments in Type 1 Diabetes.

Authors:  Jeremy Pettus; Steven V Edelman
Journal:  J Diabetes Sci Technol       Date:  2016-08-20

9.  REPLACE-BG: A Randomized Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Well-Controlled Type 1 Diabetes.

Authors:  Grazia Aleppo; Katrina J Ruedy; Tonya D Riddlesworth; Davida F Kruger; Anne L Peters; Irl Hirsch; Richard M Bergenstal; Elena Toschi; Andrew J Ahmann; Viral N Shah; Michael R Rickels; Bruce W Bode; Athena Philis-Tsimikas; Rodica Pop-Busui; Henry Rodriguez; Emily Eyth; Anuj Bhargava; Craig Kollman; Roy W Beck
Journal:  Diabetes Care       Date:  2017-02-16       Impact factor: 19.112

10.  Continuous Glucose Monitoring in Patients With Type 1 Diabetes Using Insulin Injections.

Authors:  Nicole C Foster; Kellee M Miller; William V Tamborlane; Richard M Bergenstal; Roy W Beck
Journal:  Diabetes Care       Date:  2016-04-19       Impact factor: 19.112

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  1 in total

1.  The Safety of Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Still Not Resolved.

Authors:  Alan R Shapiro
Journal:  J Diabetes Sci Technol       Date:  2017-04-18
  1 in total

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