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American Association of Clinical Endocrinologists (AACE)
American College of Endocrinology (ACE)
2016 Outpatient Glucose Monitoring Consensus Statement
Task Force Co-ChairsTimothy S. Bailey, MD, FACP, FACE, ECNU
George Grunberger, MD, FACP, FACE
ENDOCRINE PRACTICE Vol. 21 No. 2 February 2016 Pages 231-261.
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
2016 Outpatient Glucose Monitoring Consensus Statement Task Force Members
Timothy S. Bailey, MD, FACP, FACE, ECNU (Co-Chair)George Grunberger, MD, FACP, FACE (Co-Chair)Bruce W. Bode, MD, FACEYehuda Handelsman, MD, FACP, FACE, FNLA Irl B. Hirsch, MD Lois Jovanovič, MD, MACEVictor Lawrence Roberts, MD, MBA, FACP, FACEDavid Rodbard, MDWilliam V. Tamborlane, MD John Walsh, PA, CDTC
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
AACE/ACE Glucose Monitoring Consensus Statement Objectives and Structure
This consensus statement provides recommendations to clinicians regarding the type and frequency of GM technology to be employed in the
management of:
This statement also Provides a primer on GM accuracy Reviews measures of glycemic control (glucometrics) Presents graphical methods to display glycemic data
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
GDM = gestational diabetes mellitus; GM = glucose monitoring; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.
Pregnancy complicated by
preexisting diabetes or GDM
T2DM (with and without insulin
therapy)
T1DM(pediatric or adult)
Benefits and Drawbacks of CGMPros Cons
Alerts patients to • Episodes of hypoglycemia
and hyperglycemia • Predicted episodes of
hypoglycemia and hyperglycemia
Issues related to • Accuracy • Comfort• Convenience• Patient acceptance• Expense
Device displays help patients with clinical decision making
Most devices require frequent calibration
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
CGM = continuous glucose monitoring.
Adult Patients With T1DMFrequent BGM is an essential element in effective T1DM
management because it:
All major clinical practice guidelines recommend individualized, frequent BGM for patients with T1DM1,3-6
CGM is particularly important for patients with a history of severe hypoglycemia or hypoglycemia unawareness1,3,7-8
1. Joslin Diabetes Center, 2014. http://www.joslin.org/docs/Adult_guideline_-update_thru_10-23-14_2.pdf; 2. American Diabetes Association. Diabetes Care. 2015;38(Suppl 1):S1-S94; 3. American Association of Diabetes Educators. 2011. http://www.diabeteseducator.org/export/sites/aade/_resources/pdf/general/PracticeGuidelines2011.pdf; 4. Handelsman Y. Endocr Pract. 2011;17(Suppl 2):S1-S53; 5. International Diabetes Federation. 2009. Available at: http://www.idf.org/guidelines/self-monitoring; 6. Garber AJ. Endocr Pract. 2015;21(4):438-447; 7. Blevins TC. Endocr Pract. 2010;16(5):730-745; 8. Klonoff DC. J Clin Endocrinol Metab. 2011;96(10):2968-2979.
BGM = blood glucose monitoring; CGM = continuous glucose monitoring; T1DM = type 1 diabetes mellitus.
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
Detects glycemic variability and hypoglycemia
Informs treatment modifications and reflects the impact of food intake and physical activity1-3
Provides important information on
treatment efficacy1,4
Pediatric Patients With T1DMChallenges of glycemic control in pediatric patients:
Changing insulin requirementsUnpredictable food intake and physical activityConcerns about hypoglycemic riskClose monitoring needed to recognize when the patient outgrows their insulin
dose(s)1
1. Niedel S. J Health Services Research Policy. 2013; 2. Phillip M. Pediatr Diabetes. 2012;13(3):215-228.
T1DM = type 1 diabetes mellitus; A1C = glycated hemoglobin; CGM = continuous glucose monitoring.
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
CGM should be considered for regular daily use in pediatric patients with T1DM who perform frequent blood glucose testing and have:2 • Severe hypoglycemic episodes• Hypoglycemic unawareness (especially in young children)• Nocturnal hypoglycemia • Wide glucose excursions, regardless of A1C • Suboptimal glycemic control, with A1C exceeding target range • A1C levels <7%, to maintain target glycemic control while limiting hypoglycemia risk
Adult Patients With T2DMBGM should be individualized and accessible to all patients
receiving any therapy for T2DM1
Limited data on the use of real-time CGM in patients with T2DM, although available evidence is promising2-3
Trials are ongoing to evaluate the potential use of CGM (masked or unmasked) in patients with T2DM
1. International Diabetes Federation. 2009. Available at: http://www.idf.org/guidelines/self-monitoring; 2. Vigersky RA. Diabetes Care. 2012;35(1):32-38; 3. Tildesley HD. Can J Diabetes. 2013;37(5):305-308.
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
BGM = blood glucose monitoring; CGM = continuous glucose monitoring; T2DM = type 2 diabetes mellitus.
Patients receiving non-insulin agents associated with hypoglycemia:
• Perform BGM at least once daily (fasting) and periodically at other times
Patients at low risk for increased hypoglycemia risk and not at goal:
• Perform structured testing (eg, before meals and at bedtime) at least weekly
Adult Patients With T2DM
BGM is recommended for patients not taking insulin if1 • Patients and/or caregivers have knowledge, skills, and willingness to
incorporate BGM and therapeutic adjustments into diabetes care plan• Protocols are individualized to meet patient educational/behavioral/clinical
requirements and have been agreed upon by the patient and clinician
1. International Diabetes Federation. 2009. Available at: http://www.idf.org/guidelines/self-monitoring; 2. Polonsky WH. Diabetes Care. 2011;34(2):262-267.
BGM = blood glucose monitoring; T2DM = type 2 diabetes mellitus.
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
If the patient is on insulin therapy, BGM should be tailored by therapy type• Patients taking prandial and basal insulin should perform BGM when fasting,
premeal, at bedtime, and periodically during the night• Patients taking only basal insulin (with or without other diabetes medications)
should perform BGM at minimum when fasting and at bedtime
Pregnancy Complicated by DiabetesBGM is integral to diabetes management in pregnancy1
Real-time results enable women to make informed daily self-care decisions regarding diet, exercise, and insulin
Retrospective analysis of BGM data helps to: Enable clinicians to develop individualized care plans2
Inform decisions related to insulin initiation and adjustment Recognize the need for interventions to improve self-monitoring3
Potential benefit of CGM in pregnant women with preexisting diabetes is unclear
1. Jovanovic L, Pending publication; 2. Boutati EI. Diabetes Care. 2009;32(Suppl 2):S205-S210; 3. Jovanovic L. Personal communication.
BGM = blood glucose monitoring; CGM = continuous glucose monitoring.
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
Pregnancy Complicated by Diabetes
1. American Diabetes Association. Diabetes Care. 2004;27(Suppl 1):S88-S90.GDM = gestational diabetes mellitus; MNT = medical nutrition therapy.
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
•Check blood glucose levels 4 times per day:•Before breakfast (fasting) and after 3 largest meals of the day
GDM managed with MNT
•Before attempting to become pregnant, maintain glycemic control as close to normal as possible for 3 to 6 months1
Preexisting diabetes
•Monitor glucose both before and after each meal (ie, at least 6 times per day)
Diabetes managed with insulin
Glucose Monitoring Accuracy and PrecisionAccuracy is defined as the closeness of agreement between a glucose test
result and an accepted reference value Accuracy improves when it has minimal bias and relative error (%CV,
MARD, and minimal absolute error)Point accuracy refers to blood glucose values and sensor readings at
single points in time
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
BGM = blood glucose monitoring; CV = coefficient of variation; MARD = mean absolute relative deviation.
Bias: systematic error in meter or sensor measurements
Precision: measurement reproducibility (irrespective of accuracy)
May be due to improper calibration, lack of calibration, or calibration with an inaccurate BGM
May vary depending on the glucose levels being measured
Measurements may cluster around an erroneous value
It is possible to derive a measure of precision without knowing the true value
Measures of Accuracy for BGM and CGM
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
BGM = blood glucose monitor/monitoring; CGM = continuous glucose monitor.
Arithmetic deviation• The difference between true value and measured
value Absolute deviation
• The absolute value of the arithmetic deviation
Absolute relative deviation (ARD)
• The absolute deviation in relation to true value
Mean absolute relative deviation (MARD):• The mean value of individual absolute relative
deviationsMedian absolute relative deviation (MedARD):• The median value of individual absolute relative
deviations
Measures of Accuracy for BGM and CGM: MARD
This graph shows an example of accuracy results and how MARD values for CGM can vary systematically by day (eg, day 1 vs day 3 vs day 7)1Display shows:Mean (diamonds)Median (horizontal
lines within boxes) 25th and 75th
percentiles (lower and upper box edges)
Minimum and maximum values (antennae)
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
1. Pleus S. J Diabetes Sci Technol. 2013;7(4):833-841. BGM = blood glucose monitor; CGM = continuous glucose monitor; MARD = mean absolute relative deviation.
Understanding Clinical Standards for Accuracy of Current BGMs and CGMs: Error GridsThe Parkes Error Grid (2000)1 is
one way to measure accuracy Grid regions reflect the potential
risk severity of incorrect treatment triggered by the measurement error
Device performance typically reported as percentage of glucose values in zone A or zones A + B (higher percentages indicate better performance)
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
1. Parkes JL. Diabetes Care. 2000;23(8):1143-1148.
BGM = blood glucose monitor; CGM = continuous glucose monitor.
Understanding Clinical Standards for Accuracy of Current BGMs and CGMs
ISO Meter Approval StandardsISO 15197 20131 <100 mg/dL
(<5.55 mmol/L) ±15 mg/dL(±0.83 mmol/L)
95%
≥100 mg/dL(≥5.55 mmol/L)
±15%
Both FDA and ISO standards allow 5% of meter values to be outside limits99% of values must be within Consensus Error Grid zones A or B
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
1. International Organization for Standardization. 2013. Available at: http://www.iso.org/iso/catalogue_detail?csnumber=54976.
BGM = blood glucose monitor; CGM = continuous glucose monitor; FDA = US Food and Drug Administration; ISO = International Organization for Standardization.
Understanding Clinical Standards for Accuracy of Current BGMs and CGMs
FDA Draft Guidance (2014)1
50-400 mg/dL(2.8-22.2 mmol/L)
±15% 95%
and
50-400 mg/dL(2.8-22.2 mmol/l)
±20% 99%
The draft proposes smaller errors in the hypoglycemic range and fewer outliers
Testing should be performed by non-trained people2 If devices are only tested by
trained technicians, greater accuracy might be seen than when used by untrained people
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
1. US Food and Drug Administration. 2014. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380327.pdf; 2. Freckmann G, Schmid C. J Diabetes Sci Technol. 2015;9(4):885-894.
BGM = blood glucose monitor; CGM = continuous glucose monitor; FDA = US Food and Drug Administration.
Clinical Situations Requiring Increased AccuracyPatients Requiring the Highest Possible
Accuracy in Glucose Monitoring History of severe hypoglycemia
Hypoglycemia unawareness
Pregnancy
Infants and children receiving insulin therapy
Patients at risk for hypoglycemia, including: • Patients receiving basal insulin • Patients receiving basal bolus insulin therapy with multiple daily injections • Patients receiving sulfonylureas or glinides (insulin secretagogues)• Patients with irregular schedules, skipped or small meals, vigorous
exercise, travel between time zones, disrupted sleep schedules, shift work
People with occupational risks that enhance possible risks from hypoglycemia (for example, driving or operating hazardous machinery)
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
What Impacts BGM Accuracy?Manufacturing defects and test-strip lot-to-lot variations
impact BGM accuracy and introduce bias with differences up to 11%1-3
Underfilling the test strip can introduce errors >20%4 Use of alternate sites (sampling from palm, upper arm,
forearm, thigh, or calf) can generate inaccurate resultsParticularly true when glucose levels are changing rapidly
after meals or exercise when the patient is ill or under stress shortly after insulin administration5,6
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
1. Baumstark A. J Diabetes Sci Technol. 2012;6(5):1076-1086; 2. Kristensen GB. Clin Chem. 2005;51(9):1632-1636; 3. Brazg R. J Diabetes Sci Technol. 2013;7(1):144-152; 4. Pfutzner A. J Diabetes Sci Technol. 2013;7(6):1522-1529; 5. US Food and Drug Administration. 2014. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380327.pdf; 6. Riddle MC. Diabetes Care. 2010;33(5):983-990.
BGM = blood glucose monitor.
Other Factors Affecting Test ResultsFactors that interfere with glucose oxidase or glucose-1-
dehydrogenase enzyme or BGM degrade overall accuracy: Competing blood substrates (eg, maltose, vitamin C)1,2
Environmental issues (eg, cold temperature, high altitude)Contaminants on the skin from food sources and lotions3 Acetaminophen usePhysical compression of the CGM sensor during sleep4,5
Reduced accuracy and precision in tests performed by patients/other lay users compared with trained health professionals6
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
1. Dungan K. Diabetes Care. 2007;30(2):403-409; 2. Vasudevan S. Diabetes Care. 2014;37(5):e93-e94; 3. Ginsberg BH. J Diabetes Sci Technol. 2009;3(4):903-913; 4. Freckmann G. Diabetes Technol Ther. 2014;16(2):113-122; 5. Helton KL. J Diabetes Sci Technol. 2011;5(3):647-656; 6. Kilo C. Diabetes Technol Ther. 2005;7(2):283-294.
BGM = blood glucose monitor; CGM = continuous glucose monitor.
Communicating BGM Device Accuracy DataSample label information for meter and test-strip boxes
Your ABC meter result may vary slightly from your actual blood glucose value. This may be due to slight differences in technique and natural variation in the testing technology.
The chart below shows the results of a study where 350 typical users used the ABC meter to test their blood glucose levels. For example, in this study, the ABC meter gave results within 15% of their true blood glucose level 340 out of 350 times.
Difference in range between the true blood glucose level and the ABC meter result
Within Within Within Within
5% 10% 15% 20%
The percent (and number) of meter results that match true blood glucose level with x%
57% 94% 97% 100%
(200/350) (330/350) (340/350) (350/350)
Accuracy levels Meter results meeting standard
Percentage of meter values compared to laboratory values
Accurate 350 out of 350 ±15%
More Accurate 262 out of 350 ±10%
Most Accurate 175 out of 350 ±5%
Recent FDA proposed guidance document suggests labeling each BGM device and its test strips or sensors with specific performance characteristics2
This allows clinicians and patients to make informed choices
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
1. US Food and Drug Administration. 2014. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380327.pdf.
BGM = blood glucose monitor; FDA = US Food and Drug Administration.
Improving the Quality of Glycemic Control: More Than Measurement Accuracy Is NeededFeatures that provide additional information and give context to raw
glucose numbers include: Weekly or monthly glucose averages to highlight glycemic variability patterns On-screen analysis capabilities display glucose trend lines over time, and
arrows reflect magnitude of current glucose rate-of-changeBGM clock setting must be accurate, clearly visible, easy to adjust, and
maintained during battery change1 Clocks in meter, CGM, and insulin pump should be synchronized
(automatically if possible), with accommodation for travel across time zones To effectively use these informative features, many users will require
guidance Clinicians should consider ease and speed of BGM data downloading
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
BGM = blood glucose monitor; CGM = continuous glucose monitor.
1. Crowe DJ. Diabetes Technol Ther. 2005;7(5):663-664.
Post-approval Meter AccuracyIndependent laboratories should confirm ongoing routine
quality assurance verification of test-strip lots using a standardized methodology1
Studies confirm:Review of post-approval accuracy of 27 meters under 2003 ISO 15197
standard; >40% of meters failed to meet standard by which they had received approval2
2014 study found only 12 (44.4%) of 27 available BGMs met most recent 2013 ISO 15197 standard3
FDA approval does not mean a BGM will continue to meet FDA accuracy requirements
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
1. Klonoff DC. J Diabetes Sci Technol. 2013;7(4):1071-1083; 2. Freckmann G. Diabetes Technol Ther. 2010;12(3):221-231; 3. Hasslacher C. J Diabetes Sci Technol. 2014;8(3):466-472.
BGM = blood glucose monitor; FDA = US Food and Drug Administration; ISO = International Organization for Standardization.
Glucometrics: Downloading and Interpreting GM Data Glucometrics is the analysis and display of glucose data1 and can
provide insights into how medications, diet, stress, and activity contribute to diabetes control2,3
Patient-to-health care team communication methods can include:Logbook during office visitComputer outputs Periodic phone calls, faxes, or emails to office Automated transfer from meter or sensor to Internet for review Automated interpretation by glucose monitoring device
Glucose and related data should be integrated with an electronic health record
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
1. Rodbard D. Diabetes Technol Ther. 2009;11(Suppl 1):S55-S67; 2. Bailey TS. Diabetes Technol & Ther. 2007;9(3):203-210; 3. Rodbard D. J Diabetes Sci Technol. 2007;1(1):62-71.
GM = glucose monitoring.
Representing Glucometric DataMean, median, and %CV metrics describe overall
glycemiaAverage glucose level may represent the mean or median The SD of glucose is highly correlated with mean glucose
%CV is usually the best method to characterize variability1-6
Other methods describe actionable patterns to help clinicians optimize diabetes therapy In graphical presentation, “standard day,” “modal day,”7,8 or AGP
displays individual glucose measurements (pooled over multiple days) by time of day on a single 24-hour scale
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
1. Kaufman FR. Diabetes Care. 2001;24(12):2030-2034; 2. Potts RO. Diabetes Metab Res Rev. 2002;18(Suppl 1):S49-S53; 3. JDRF. Diabetes Tech & Ther. 2008;10(4):310-321; 4. Rodbard D. Postgrad Med. 2011;123(4):107-118; 5. DeVries JH. Diabetes. 2013;62(5):1405-1408; 6. Rodbard D. J Diabetes Sci Technol. 2015;9(1):56-62; 7. Mazze RS. Diabetes Care. 1987;10(1):111-117; 8. Rodbard D. Diabetes Care. 1988;11(Suppl 1):S54-S61.
AGP = ambulatory glucose profile; CV = coefficient of variation; SD = standard deviation.
Standard or Modal Day
Glucose Profile by Time of Day1 Glucose in Relation to Meals2
The “Standard Day” or “Modal Day” graph indicates both glucose values and times of day when monitoring occursFacilitates detection of consistent patterns in glucose excursions Provides assessment of glucose monitoring adequacyGenerally shows glucose values by time of day but can show them in relation to
meals
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
1. Rodbard D. J Diab Sci Technol. 2009;3(6):1388-1394; 2. Pernick N. Diabetes Care. 1986;9(1):61-69.
Ambulatory Glucose Profile
Patient With Normal Glucose Tolerance
To generate AGP: Blood glucose levels are measured via BGM or CGM All glucose data pooled and analyzed as if it had been collected during a single
24-hour period Result is a standardized software report that can be displayed graphically
AGP provides an excellent starting point for a standardized computerized display of BGM and/or CGM data by time of day1-3
AGP display for multiple days of CGM data with
estimates of 10th, 25th, 50th, 75th, and
90th percentiles
Patient With T1DM
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
1. Bergenstal RM. J Diabetes Sci Technol. 2013;7(2):562-578; 2. Rodbard D. J Diabetes Sci Technol. 2015;9(1):56-62; 3. Mazze RS. Diabetes Care. 1987;10(1):111-117.
AGP = ambulatory glucose profile; BGM = blood glucose monitor; CGM = continuous glucose monitor; T1DM = type 1 diabetes mellitus
Graphic AGP Display: T2DMThe solid curve in the
middle represents the smoothed median glucose (50th percentile) values for a 24-hour period
The striped, shaded area shows the presumptive target range (70-180 mg/dL or 3.9-10 mmol/l)
Patient With T2DM
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
Bergenstal R. J Diab Sci Technol. 2013;7(2):562-578.
AGP = ambulatory glucose profile; CGM = continuous glucose monitor; IQR = interquartile range; T2DM = type 2 diabetes mellitus.
Other Graphical Displays of Glucometric Data
Other ways that graphic data related to glucose changes over time can be displayedPie graphsSimple bar charts Box plotsScattergramsStacked bar chartsHistograms
The purpose of these displays is to help clinicians identify and prioritize clinical problems and educate and motivate the patient to achieve improved glycemic control
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
RecommendationsPatients should be educated to interpret and use GM data to:
Enhance their ability to self-adjust therapy Decide when to seek medical assistance
To assess glucometrics, physicians should first examine: Overall statistics (mean, SD, %CV)Distribution of glucose valuesGlucose by date, by time of day and in relationship to meals, and by
day of the weekThe most helpful glucometric graphical displays show:
Graphs of glucose by dateAGP by time of dayStacked bar charts and/or box plots by time of day, in relation to
meals, and by day of the week
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
AGP = ambulatory glucose profile; CV = coefficient of variation; GM = glucose monitoring; SD = standard deviation.
Glucose Monitoring, Looking ForwardImprovements in progress
Data-sharing via the Internet Use of additional displays Improved usability Comprehensive and standardized integration of multiple
data inputs Several mobile health applications have been developed,
enabling patients to monitor and adjust their lifestyle and therapy on a real-time basis
CGM developments may broaden the appeal and applicability of CGM in T1DM and T2DM
Copyright © 2016 AACE. May not be reprinted in any form without express written permission from AACE.
CGM = continuous glucose monitoring; T1DM = type 1 diabetes mellitus; T2DM = type 2 diabetes mellitus.
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