What Can We Learn From Point-of-Care Blood Glucose Values Deleted and Repeated by Nurses?

Glucose meter evaluations are common in publications and inform whether the meter meets the ISO 15197 specification. The ISO 15197 specifications, which are universally cited, leave 1% of results unspecified, which can be thought of as typical performance of results (99%) versus rare performance (1%). Suggestions are provided to extract more information from these evaluations, including rare performance, since highly discrepant results or failure to obtain a result can be observed in a glucose meter that has met the ISO 15197 specification. It is also recommended that when manufacturers perform evaluations, they analyze adverse events contained in the FDA MAUDE database. Finally, we point out an important problem with the ISO 15197 specifications.

Section: Resultsmentioning

confidence: 99%

Getting More Information From Glucose Meter Evaluations

Krouwer¹,

Garrett

2019

“…Problems are often caused by user error for BG. 11 And outliers are the rule, not the exception. For example, when inaccuracy was noted for a CGM value and when there was a corresponding BG result, the data point (Y=CGM, X=BG) was almost always in B or higher zones on a Parkes error grid.…”

Section: The Spectrum Of Performance Evaluations (Bg and Cgm)mentioning

confidence: 99%

Adverse Event Data for Years 2018 to 2020 for Diabetes Devices

Krouwer¹

2021

Unlike performance evaluations, which are often conducted under ideal conditions, adverse events occur during actual device use for people with diabetes. This report summarizes the number of adverse events for the years 2018 to 2020 for the 3 diabetes devices: blood glucose meters (BG), continuous glucose monitors (CGM), and insulin pumps. A text example of a CGM injury is provided. Possible reasons are suggested for trends. Whereas the rate per test result (events/usage) is exceedingly small, the rate per patient (events/people with diabetes that use insulin) is of concern. Hence, it is important to determine event causes and provide corrective actions. The first step is to put in place routine analysis of adverse event data for diabetes devices.

“…A retrospective review showed that only 0.8% of POC BG tests are repeated; however, using this strategy reduced reporting error and improved documentation of SH by as much as 40%. 17…”

Section: Identifying Inpatient Hypoglycemiamentioning

confidence: 99%

Inpatient Hypoglycemia: The Challenge Remains

Cruz

2020

Hypoglycemia in inpatients with diabetes remains the most common complication of diabetes therapies. Hypoglycemia is independently associated with increased morbidity and mortality, increased length of stay, increased readmission rate, and increased cost. This review describes the importance of reporting and addressing inpatient hypoglycemia; it further summarizes eight strategies that aid clinicians in the prevention of inpatient hypoglycemia: auditing the electronic medical record, formulary restrictions and dose-limiting strategies, hyperkalemia order sets, electronic glucose management systems, prediction tools, diabetes self-management, remote surveillance, and noninsulin medications.