Regulatory Controversies Surround Blood Glucose Monitoring Devices

Klonoff, David C.

doi:10.1177/193229681000400201

Cited by 25 publications

(20 citation statements)

References 17 publications

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“…[1][2][3] I plan only to discuss SMBG since the intended use of most monitors is for this purpose. Self-monitoring of blood glucose is used by three major distinct groups of people with diabetes: (A) patients with type 2 diabetes on diet and/or medications that do not cause hypoglycemia, (B) patients with type 2 diabetes using insulin or medications that can cause hypoglycemia, and (C) patients with type 1 diabetes.…”

Section: Introductionmentioning

confidence: 99%

We Need Tighter Regulatory Standards for Blood Glucose Monitoring, but They Should Be for Accuracy Disclosure

Ginsberg

2010

J Diabetes Sci Technol

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Regulatory interest has focused on the accuracy of blood glucose monitoring systems. Currently, almost all systems meet the International Organization for Standardization (ISO) 15197 clinical standard (≥95% of the values within 20% of the reference for values above 75 mg/dl and within 15 mg/dl below that level). Should the systems have to meet one of the extended ISO standards of 15%, 10%, or even 5%? There is a wide variety of people with diabetes doing glucose monitoring, and the majority do not need better accuracy. Indeed, when selecting an insulin dose, the inaccuracy of the glucose reading has little effect compared with the inaccuracy in counting carbohydrates and the variability in insulin absorption. It might be far better to evaluate the accuracy in a standard method and provide the accuracy values on a standard label. Patients and health care providers could then select the monitoring system that best meets their needs.

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Section: Introductionmentioning

confidence: 99%

We Need Tighter Regulatory Standards for Blood Glucose Monitoring, but They Should Be for Accuracy Disclosure

Ginsberg

2010

J Diabetes Sci Technol

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“…The majority of results from both subjects and HCPs (97.3% for each) were [18][19][20] it will become increasingly important for technology to deliver accurate blood glucose meters in light of the more stringent criteria that may emerge and also to enable patients to readily use devices to obtain optimal results to help manage their diabetes.…”

Section: Discussionmentioning

confidence: 99%

Performance Evaluation and Labeling Comprehension of a New Blood Glucose Monitoring System with Integrated Information Management

List¹,

Starks²,

Baum

et al. 2011

J Diabetes Sci Technol

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“…[25][26][27] Sampling source (eg, arterial, venous, or capillary blood) can also lead to variability in results. 28,29 Nonetheless, any extreme or questionable values by POC-BG could always be confirmed via laboratory testing if needed. Our prior report identified a paucity of POC-BG devices in the operating suites, which was subsequently corrected.…”

Section: -4mentioning

confidence: 99%

Update on a Quality Initiative to Standardize Perioperative Care for Continuous Subcutaneous Insulin Infusion Therapy

Mackey

Thompson

Boyle

et al. 2015

J Diabetes Sci Technol

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Objective: The objective of the analysis was to review the effectiveness of a care process model (CPM) developed to guide management of patients on insulin pump therapy undergoing elective surgical procedures. Methods: Electronic medical records were reviewed to assess the impact of the CPM on documentation of insulin pump status, glucose monitoring, and safety during the perioperative phase of care. Post-CPM care was compared with management provided before CPM implementation. Results: We reviewed 45 cases on insulin pump therapy in the pre-CPM cohort and 106 in the post-CPM cohort. Demographic characteristics, categories of surgery, and perioperative times were not significantly different between the 2 groups. Recommended hemoglobin A1c monitoring occurred in 73% of cases in the pre-CPM cohort but improved to 94% in the post-CPM group ( P < .01). There was a higher frequency of documentation of the insulin pump during the preoperative, intraoperative, and postanesthesia care unit segments of care in the post- vs pre-CPM periods (all P < .01). The number of cases with intraoperative glucose monitoring increased (57% pre-CPM vs 81% post-CPM; P < .01). Glycemic control was comparable between the 2 CPM periods. Hypoglycemia was rare, with only 3 episodes in the pre-CPM group and 4 in the post-CPM. No adverse events associated with perioperative insulin pump use were observed. Conclusions: This analysis adds to previous data on use of insulin pump therapy during the perioperative period. Some processes require additional attention, but data continue to indicate that a standardized approach to care can lead to a successful and safe transition of insulin pump therapy throughout the perioperative period.

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Regulatory Controversies Surround Blood Glucose Monitoring Devices

Cited by 25 publications

References 17 publications

We Need Tighter Regulatory Standards for Blood Glucose Monitoring, but They Should Be for Accuracy Disclosure

We Need Tighter Regulatory Standards for Blood Glucose Monitoring, but They Should Be for Accuracy Disclosure

Performance Evaluation and Labeling Comprehension of a New Blood Glucose Monitoring System with Integrated Information Management

Update on a Quality Initiative to Standardize Perioperative Care for Continuous Subcutaneous Insulin Infusion Therapy

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