Blood Glucose Monitors 

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Blood glucose monitors are devices that measure blood glucose levels electronically. They are indicated for individuals with diabetes mellitus type 1 or 2.

In February 2014, the FDA expanded its approval of the Dexcom G4 Platinum continuous glucose monitoring (CGM) system to include use in children aged 2 to 17 years of age, making it the first CGM system approved for use in young children. The FDA cautions that in studies in pediatric patients, the device was not as accurate as it is in adults, and its ability to issue an alert at glucose levels in the hypoglycemic range in children was poor. The product’s label will include warnings about these limitations. ^{[1, 2]}

Blood glucose meters measure blood glucose levels electronically. Such measurement utilizes only a small drop of blood from the fingertip placed on a disposable test strip. The digital meter obtains information from the blood on the strip, and within seconds, the glucose level is displayed on the screen. Patient discomfort and inconvenience are minimal, and compliance with testing regimens is therefore high.

A continuous blood glucose monitor (CGM) assesses blood glucose levels on a near-continuous basis. A typical system consists of a glucose sensor placed subcutaneously, a non-implanted transmitter, and a receiver worn like a pager, which records blood glucose levels at frequent intervals and monitors trends.

CGM systems monitor interstitial fluid glucose levels. They must be calibrated with traditional fingerstick tests.

Continuous monitoring provides documentation of blood glucose response to insulin dosing, eating, exercise, and additional influences. Overnight monitoring may identify problems with insulin dosing and allow adjustments of basal levels. Many units are equipped with alarms to warn patients of hyperglycemia or hypoglycemia and provide time for treatment.

Blood glucose monitors are devices that measure blood glucose levels electronically.

Blood glucose monitors

Dozens of blood glucose monitors are commercially available. The following examples do not represent an all-inclusive list and are in no specific order.

Roche Diagnostics – ACCU-CHEK

Nova Biomedical – Nova Max Plus, Nova Max Link

Abbott Diabetes Care – Precision Xtra, FreeStyle Lite, FreeStyle Freedom Lite

LifeScan – OneTouch

Nipro Diagnostics – TRUE2go, TRUEresult, TRUEtrack

Diagnostic Devices – Prodigy

Diabetic Supply of Suncoast – Advocate

Arkray – GLUCOCARD

Bayer Diabetes Care – Contour, Breeze 2

Sanofi – iBGStar (the first blood gluse meter to connect directly to iPhone or iPod Touch)

Blood glucose meters measure blood glucose levels electronically. Such measurement utilizes only a small drop of blood from the fingertip placed on a disposable test strip. The digital meter obtains information from the blood on the strip, and within seconds, the glucose level is displayed on the screen. Patient discomfort and inconvenience are minimal, and compliance with testing regimens is therefore high. There is a recurring cost to using blood glucose meters and disposable strips, but it is outweighed by the costs related to complications of diabetes.

Alternate-site testing uses the same meter and strip but acquires blood from the palm or the forearm. Thus, it causes virtually no pain and allows patients to rest sore fingertips. The disadvantage of alternate-site testing is that decreased blood flow may be encountered and may affect testing accuracy.

Multitest systems are available that utilize a cartridge or a disk with multiple test strips. These systems may be more convenient for patients.

Many meters allow patients to download results to a computer so that they can be shared with their health care provider; this has the potential to improve diabetes management.

iBGStar (Sanofi) is the first blood glucose meter to connect directly to iPhone and iPod Touch. It uses the iBGStar Diabetes Manager application for recording, tracking, managing, and sharing blood glucose data. Recent research has shown good interassay and high intra-assay precision using the device. ^[3]

A continuous blood glucose monitor (CGM) assesses blood glucose levels on a near-continuous basis. A typical system consists of a glucose sensor placed subcutaneously, a nonimplanted transmitter, and a receiver worn like a pager, which records blood glucose levels at frequent intervals and monitors trends.

CGM systems monitor interstitial fluid glucose levels. They must be calibrated with traditional fingerstick tests. Before treatment of reported hypoglycemia or hyperglycemia with insulin, confirmation with a fingerstick test is recommended because of the 5- to 15-minute lag in data reporting.

Continuous monitoring provides documentation of blood glucose response to insulin dosing, eating, exercise, and additional influences. Overnight monitoring may identify problems with insulin dosing and allow adjustments of basal levels. Many units are equipped with alarms to warn patients of hyperglycemia or hypoglycemia and provide time for treatment. Studies have demonstrated that patients using CGMs experience fewer hyperglycemic episodes and may decrease their glycated hemoglobin (HbA1C) levels. ^{[4, 5, 6]}

One recent concern, however, is proper calibration and availability of control solutions at pharmacies and appropriate use by patients during calibration. Lack of adherence to proscribed methodologies of use may lead to erroneous data and thus possible mistreatment of diabetes by patients. ^[7] Future development and technological advancements aim to allow for improved sensors and calibration software, creating better systems designed to automate delivery of insulin partially (eg, low glucose suspend) or entirely (eg, “fully closed-loop” artificial pancreas). ^[8]

Blood glucose monitors are indicated in individuals with diabetes mellitus type 1 or 2.

There is extensive evidence demonstrating the utility of blood glucose testing in persons with diabetes, especially those using insulin. Patients with diabetes who use insulin typically test their blood sugar more often (3-10 times per day) to assess the effectiveness of the previous dose and to determine the next dose.

Blood glucose monitoring allows patients to understand patterns of blood glucose changes and to adjust diet, exercise, and medication dosing. Neither the significance nor the optimal frequency of monitoring has yet been clearly elucidated in patients with diabetes mellitus type 2.

Health care providers should follow standard protocols for monitoring blood glucose levels. Information gathered from blood glucose monitors and glycated hemoglobin (HbA1C) levels may help guide management of patients with diabetes. Monitoring of patients with newly diagnosed diabetes may also help patients achieve a better understanding of their disease.

Complications of using blood glucose monitors include pain and soreness caused by the testing prick.

Tucker M. FDA Approves Continuous Glucose Monitor for Children. Available at http://www.medscape.com/viewarticle/820154. Accessed: February 17, 2014.

FDA news release. FDA approves pediatric use of Dexcom’s G4 Platinum continuous glucose monitoring system. Available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm384495.htm. Accessed: February 17, 2014.

Ramljak S, Musholt PB, Schipper C, Flacke F, Sieber J, Borchert M. The precision study: examining the inter- and intra-assay variability of replicate measurements of BGStar, iBGStar and 12 other blood glucose monitors. Expert Opin Med Diagn. 2013 Nov. 7(6):511-6. [Medline].

Deiss D, Bolinder J, Riveline JP, Battelino T, Bosi E, Tubiana-Rufi N, et al. Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care. 2006 Dec. 29(12):2730-2. [Medline].

Wentholt IM, Vollebregt MA, Hart AA, Hoekstra JB, DeVries JH. Comparison of a needle-type and a microdialysis continuous glucose monitor in type 1 diabetic patients. Diabetes Care. 2005 Dec. 28(12):2871-6. [Medline].

Battelino T, Phillip M. Real-time continuous glucose monitoring in randomized control trials. Pediatr Endocrinol Rev. 2010 Aug. 7 Suppl 3:401-4. [Medline].

Chaudhry T, Klonoff DC. SMBG out of control: the need for educating patients about control solution. Diabetes Educ. 2013 Sep-Oct. 39(5):689-95. [Medline].

Lane JE, Shivers JP, Zisser H. Continuous glucose monitors: current status and future developments. Curr Opin Endocrinol Diabetes Obes. 2013 Apr. 20(2):106-11. [Medline].

Bode BW. Use of rapid-acting insulin analogues in the treatment of patients with type 1 and type 2 diabetes mellitus: insulin pump therapy versus multiple daily injections. Clin Ther. 2007. 29 Suppl D:S135-44. [Medline].

DeWitt DE, Hirsch IB. Outpatient insulin therapy in type 1 and type 2 diabetes mellitus: scientific review. JAMA. 2003 May 7. 289(17):2254-64. [Medline].

FDA Consumer Upate 2009 – Getting Up to Date on Glucose Meters. Available at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049051.htm.

FDA Consumer Update 3/21/2013 – Useful Tips to Increase Accuracy and Reduce Errors in Test Results from Glucose Meters. Available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109519.htm.

FDA Consumer Update 3/23/2013- Common Problems with the Use of Glucose Meters at the Point of Care. Available at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109449.htm.

FDA Guidelines. Blood Glucose Monitoring Test Systems for Over-the-Counter Use. [Full Text].

FDA Guidelines. Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use. Jan 2014. [Full Text].

FDA Guidelines: Blood Glucose Monitoring Devices. Available at http://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/glucosetestingdevices/default.htm. Accessed: June 2014.

Freckmann G, Baumstark A, Jendrike N, et al. System accuracy evaluation of 27 blood glucose monitoring systems according to DIN EN ISO 15197. Diabetes Technol Ther. 2010 Mar. 12(3):221-31. [Medline].

Hamaty M. Insulin treatment for type 2 diabetes: When to start, which to use. Cleve Clin J Med. 2011 May. 78(5):332-42. [Medline].

International Diabetes Federation. Guideline on Self-Monitoring of Blood Glucose in Non-Insulin Treated Type 2 Diabetes. [Full Text].

Klonoff DC, Buckingham B, Christiansen JS, Montori VM, Tamborlane WV, Vigersky RA, et al. Continuous glucose monitoring: an Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2011 Oct. 96(10):2968-79. [Medline]. [Full Text].

Practice Advisory Blood Glucose Meter Accuracy. Sept 16, 2013. [Full Text].

Standards of medical care in diabetes–2014. Diabetes Care. 2014 Jan. 37 Suppl 1:S14-80. [Medline]. [Full Text].

Steil GM, Rebrin K, Mastrototaro J, Bernaba B, Saad MF. Determination of plasma glucose during rapid glucose excursions with a subcutaneous glucose sensor. Diabetes Technol Ther. 2003. 5(1):27-31. [Medline].

Stolar MW. Defining and achieving treatment success in patients with type 2 diabetes mellitus. Mayo Clin Proc. 2010 Dec. 85(12 Suppl):S50-9. [Medline].

van Belle TL, Coppieters KT, von Herrath MG. Type 1 diabetes: etiology, immunology, and therapeutic strategies. Physiol Rev. 2011 Jan. 91(1):79-118. [Medline].

Wilhelm B, Forst S, Weber MM, Larbig M, Pfutzner A, Forst T. Evaluation of CGMS during rapid blood glucose changes in patients with type 1 diabetes. Diabetes Technol Ther. 2006 Apr. 8(2):146-55. [Medline].

Benjamin Daniel Liess, MD Assistant Professor, Department of Otolaryngology, University of Missouri-Columbia School of Medicine

Benjamin Daniel Liess, MD is a member of the following medical societies: American Academy of Otolaryngic Allergy, American Academy of Otolaryngology-Head and Neck Surgery, The Triological Society, American Medical Association, Missouri State Medical Association

Disclosure: Nothing to disclose.

George T Griffing, MD Professor Emeritus of Medicine, St Louis University School of Medicine

George T Griffing, MD is a member of the following medical societies: American Association for the Advancement of Science, International Society for Clinical Densitometry, Southern Society for Clinical Investigation, American College of Medical Practice Executives, American Association for Physician Leadership, American College of Physicians, American Diabetes Association, American Federation for Medical Research, American Heart Association, Central Society for Clinical and Translational Research, Endocrine Society

Disclosure: Nothing to disclose.

Blood Glucose Monitors 

Research & References of Blood Glucose Monitors |A&C Accounting And Tax Services
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