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Regulatory Controversies Surround
Blood
Glucose Monitoring Devices
David C. Klonoff, MD, Editor in Chief,
Journal
of Diabetes Science and Technology
Volume 4, Issue 2, March
2010
Blood glucose (BG)
monitoring devices are coming under regulatory scrutiny
because of a growing concern that greater accuracy is
needed, especially for use in hospitals and long-term
facilities, and various substances can interfere with
accurate readings and lead to incorrect insulin dosing
and hypoglycemia.
Upcoming Food and Drug Administration (FDA) Meeting
about BG Meters
The FDA has announced that they will be presenting a
meeting on “Clinical Accuracy Requirements for Point of
Care Blood Glucose Meters” on March 16 and 17, 2010. The
meeting’s goals are to: (1) raise public awareness about
the accuracy and clinical use of BG meters; (2) obtain
public input about the accuracy and clinical use of BG
meters; and (3) work toward identifying solutions. The
meeting’s three sessions will cover: (1) clinical
accuracy requirements for BG meters; (2) BG meter
performance, interferences, and limitations; and tight
glycemic control, especially in the hospital setting.
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Inpatient
Glucose Control:
A Glycemic Survey of 126 U.S. Hospitals
Journal of
Hospital Medicine 2009;4:E7–E17. VC 2009 Society of
Hospital Medicine.
Curtiss B. Cook, MD, FACP, Gail L. Kongable, RN, MSN,
FNP, Daniel Jason Potter, MA, Victor J. Abad, MA, Dora
E. Leija, MA, Marcy Anderson, MS, Mayo Clinic College of
Medicine, Scottsdale, Arizona. The Epsilon Group
Virginia, LLC, Charlottesville, Virginia. Medical
Automation Systems, Charlottesville, Virginia.
A total of 12,559,305 POC-BG measurements were analyzed:
2,935,167 from the ICU and 9,624,138 from the non-ICU.
Patient-day-weighted mean POC-BG was 165 mg/dL for ICU
and 166 mg/dL for non-ICU. Hospital hyperglycemia (>180
mg/dL) prevalence was 46.0% for ICU and 31.7% for
non-ICU. Hospital hypoglycemia (<70 mg/dL) prevalence
was low at 10.1% for ICU and 3.5% for non-ICU. For ICU
and non-ICU there was a significant relationship between
number of beds and patient-day-weighted mean POC-BG
levels, with larger hospitals ( 400 beds) having lower
patient-day weighted mean POC-BG per patient day than
smaller hospitals (<200 beds, P < 0.001). Rural
hospitals had higher POC-BG levels compared to urban and
academic hospitals (P < 0.05), and hospitals in the West
had the lowest values.
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Sliding
Scale vs Tight Glycemic Control
Diabetes In
Control
Patients treated with TC experienced more blood
glucose measurements in the target range as compared
with patients treated with SS with relatively low
hypoglycemia rates.
Development of hyperglycemia during hospitalization is
an area of concern in patients with and without diabetes
mellitus. Tight glycemic control has been debated for
critically ill and noncritically ill patients with
hyperglycemia. Although many studies have been performed
in the critically ill, adequate data are not available
in the noncritically ill population.
To compare traditional sliding scale (SS) with a tight
glycemic control (TC) algorithm. The primary endpoint
was the percentage of total blood glucose measurements
in the target range of 80-150 mg/dL. The secondary
endpoint evaluated was safety, defined as percentage of
all blood glucose measurements that were 0-60 mg/dL.
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Inpatient
Hyperglycemia Management:
The
Voyage Continues!
Dr. Rattan
Juneja and Dr. Tim Meakem; Editorial: Crit Care Med 2009
Vol. 37, No. 12
We have known for some time now the strong association
between hyperglycemia and increased risk of
complications in hospitalized patients. We have also
known that in-hospital hyperglycemia confers increased
risk of mortality not only in patients with diabetes,
but especially in those who manifest hyperglycemia for
the first time during critical illness. These findings
were supported in the sentinel clinical trial by van den
Berghe et al, in which critically ill surgical patients
randomized to a tight glucose target of 80 to 110 mg/dL
experienced significant reductions in morbidity and
mortality when compared with a glucose range of 180 to
200 mg/dL. This trial was the genesis for the concept
and promotion of tight glucose control (TGC) in all
critically ill patients.
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Glucose
Control and Its Implications
for the
General Surgeon
MAYA LEGGETT,
M.D., BRIAN G. HARBRECHT, M.D. From the Department of
Surgery, University of Louisville, Louisville Kentucky,
for the American Surgeon.
THERE HAS BEEN AN INCREASING amount of literature over
the last few years describing the importance of glucose
control in hospitalized patients. Normalization of blood
glucose levels in both diabetic and nondiabetic patients
has been proposed to improve outcome and reduce the
short term and long term adverse consequences of
hyperglycemia. Several regulatory or advisory groups
have even promoted tight glucose control as a process
that should be monitored in critically ill patients to
assess the quality of care.
More >>
PROS AND
CONS:
Tight Perioperative Glycemic Control
Journal of
Cardiothoracic and Vascular Anesthesia, Vol 23, No 6
(December), 2009
Lee A. Fleisher, MD and Bonnie L. Milas, MD, Section
Editors of the Journal of Cardiothoracic and Vascular
Anesthesia weigh the pros and cons of this
subject.
More >>
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