This policy addresses devices used for glucose and Hb A1C monitoring as used in the management of diabetes type 1 and 2.

Note: For information regarding insulin pumps please see:

• CG-DME-01 External (Portable) Insulin Infusion Pump
• SURG.00068 Implantable Infusion Pumps

1. Blood Glucose Monitoring:

   
   Medically Necessary:

   
   FDA-approved standard blood glucose monitors are considered medically necessary for individuals with any of the following conditions:
   
   

   • Type 1 diabetes; or
   • Type 2 diabetes; or
   • Gestational diabetes (diabetes during pregnancy); or
   • Diabetes secondary to other conditions.

   
   Blood glucose monitors with certain special features to allow easy use for patients with visual impairment are considered medically necessary for patients with documented severe visual impairment (20/200 or greater severity).

   
   The following supplies related to blood glucose monitors are considered medically necessary:
   
   

   1. Blood glucose monitoring strips (reagent strips)
   2. Lancets, including spring-powered lancets (excluding laser lancets)
   3. Other supplies, including replacement batteries, and normal, low and high calibrator solution/chips

   
   Not Medically Necessary:

   
   Combination glucose/fructosamine home testing devices are considered not medically necessary.

   
   Any additional software or hardware required for downloading data from blood glucose monitors to computers is considered not medically necessary.

   
   Blood glucose monitors for individuals with a diagnosis of “impaired glucose tolerance”, “pre-diabetes” or similar terminology is considered not medically necessary.

   
   Laser lancets are considered not medically necessary.
   
   Blood glucose monitors with special features not directly related to diabetes care (i.e., integrated cell phones, etc.) are considered not medically necessary.
   
   Investigational/Not Medically Necessary:

   
   Glucose monitors that are not FDA-approved, including, but not limited to, those using infrared spectroscopy, are considered investigational/not medically necessary.
   
   

2. Monitoring of Glucose in the Interstitial Fluid (i.e., continuous glucose monitoring):

   
   Medically Necessary:

   
   Use of invasive subcutaneous or noninvasive continuous interstitial glucose monitoring devices as an adjunct to standard care are considered medically necessary in the care of patients with Type 1 diabetes, when all of the following criteria are met:
   
   

   1. Inadequate glycemic control despite compliance with frequent self-monitoring (at least four times per day) and including fasting hyperglycemia (>150 mg/dl) or recurring episodes of severe hypoglycemia (<50 mg/dl). This poor control is in spite of compliance with multiple alterations in self-monitoring and insulin administration regimens to optimize care; and
   2. Insulin injections are required 3 or more times per day or an insulin pump is used for maintenance of blood sugar control; and
   3. Four or more fingersticks are required per day; and
   4. Monitoring and interpretation under the supervision of a physician; and
   5. For the invasive subcutaneous continuous interstitial glucose monitoring devices only, is used for seventy-two (72) consecutive hours on an appropriate, periodic basis.

   
   Note:  Subcutaneous continuous interstitial glucose monitoring devices are used episodically to direct changes in diabetic management. Given the several month timeframe to determine the efficacy of these treatment modifications, it is anticipated that when the above medical necessity criteria are met, the devices would be used only two times in a given year.

   
   Investigational/Not Medically Necessary:

   
   Use of noninvasive or invasive continuous interstitial glucose monitoring devices and related supplies are considered investigational/not medically necessary for any additional indications not meeting the above criteria.
   
   Use of the Paradigm® REAL-Time System is considered investigational/not medically necessary for all uses.
   
   

3. Glycated Serum Protein Monitoring

   
   Investigational/Not Medically Necessary:

   
   Use of hemoglobin A1c (HbA1c) or other glycosylated serum protein monitors for use in the home setting is considered investigational/not medically necessary.

The use of blood glucose monitors in patients with diabetes is a well-established method used to assist in the management of blood glucose levels in type 1 and type 2 and other forms of diabetes.  Numerous clinical trials and several decades of clinical experience support the use of these devices as the standard of care in this patient population.

Standard blood glucose monitoring devices usually have small display screens or other limitations that prevent visually impaired patients from being able to successfully benefit from using the device.  Newer devices designed with special features for individuals who have visual impairments, such as bigger screens, significantly improve the ability of these patients to gain benefit from blood glucose monitoring.

These blood glucose monitoring devices require many additional supplies to support their use. Blood glucose monitoring strips, lancets, batteries and calibration materials are all necessary for the successful utilization of blood glucose monitors.  While laser lancets for blood drawing are available on the market, any clinical benefit they may have beyond standard blood collection methods has not been established in the medical literature.

The evidence from several clinical trials of continuous interstitial glucose monitoring has demonstrated that the devices accurately monitor blood glucose levels (Bode 200b; Garg, 1999).  Additionally, there is adequate evidence that the short-term, periodic use of these devices allow treating physicians to correlate glucose concentration trends with daily activities.  Proper analysis of the patterns derived from the correlation between blood glucose and interstitial glucose measurements, in addition to data from a concurrent self-management diary, can impact the care of a small sub-set of patients with type 1 diabetes who continue to have inadequate glycemic control, despite optimal care and adherence (Bode, 2000a; Chase, 200a, Chase 200b). 

Both the GlucoWatch® device and the Guardian Continuous Glucose Monitoring Device are also equipped with alarms that enable prompt identification of hypoglycemic events. However, a trial of 71 patients investigating the ability of the CGMS and the Guardian devices to detect hypoglycemia and to alert patients to such events reported poor results.  At a threshold of 60 mg/dl the sensitivity of the devices was only 36% and 49% respectively with a false alarm rate of 63% and 58%.  As the threshold was raised from 60 mg/dl to 100 mg/dl, sensitivity increased to 85% and 100% respectively, but at the expense of false alarm rates near 75%.  In another study of 71 subjects, the Guardian device was able to distinguish between glucose levels above and below 70 mg/dL with 67% sensitivity, 90% specificity, but with a 47% rate of false alerts (Bode, 2004).

The use of continuous glucose monitoring more frequently than intermittent 72 hour periods has not been demonstrated to provide any long-term benefits. A study by Deiss and colleagues describes a randomized controlled trial using the Guardian RT device (2006).  The study involved 156 children and adult patients with type 1 diabetes and divided them into 3 groups; one using the Guardian RT monitor continuously, one using it biweekly for 3-day periods, and a conventional self monitoring control group.  Patients were followed for 3 months.  The authors reported that at 1 and 3 months there was decrease in HbA1c for all groups, with greater decreases in the continuously monitored group compared to the control group (p= 0.008 at 1 month p = 0.003 at 3 months).  One episode of hypoglycemia occurred in both the continuously monitored and intermittently monitored group.  Total insulin use did not change.  This study did not specifically report on the utility of the alarm function of this device, and no conclusions can be made as to the impact of such functionality during this study.  Additionally, study participants did not register specific information regarding their self management on a daily basis, making the correlation between the use of the continuous glucose monitoring and improvements in glycemic control difficult.  The authors’ conclude that the results of this preliminary study are promising and that use of the Guardian RT on a periodic basis can improve blood glucose control and long-term HbA1c measurements. However, they also note that but that further investigations are needed to define treatment guidelines when using continuous monitoring and that other aspects of this new technique such as long term efficacy need to be investigated.

On April 7, 2006 the FDA granted approval for the MiniMed the Paradigm® REAL-Time System.  This system combines an insulin pump with a wireless invasive continuous interstitial glucose monitor similar to that of the Guardian device.  The Paradigm device includes special features like real-time read-out and glucose trend graphing and indicators.  At this time there is no evidence in the peer-reviewed medical literature addressing any potential health outcome benefits of such a combined device.  In addition, there is insufficient evidence available regarding any potential benefit of continuous interstitial glucose monitoring over extended periods of time.

Other types of blood glucose monitors have been made available on the market with such features as fingerstickless measurement, continuous blood glucose monitoring, and combination glucose and fructosamine testing. The medical literature addressing these devices is extremely limited.

Many types of blood glucose monitors now offer the ability to collect and transfer data to various electronic devices including computers and personal digital assistants. While such data collection may be useful, the benefit of using electronic devices for such data collection over more traditional methods has not been established. 

For patients with impaired glucose tolerance, blood glucose monitoring has not been proven clinically useful.  Such patients are not at high risk for severe swings in blood sugar and do not require insulin injections or drugs that would necessitate the use of blood glucose monitoring devices.

Several devices using infrared spectroscopy and other methods have been suggested for the monitoring of blood glucose concentrations.  These devices have not received approval from the Food and Drug Administration of the United States and cannot be used outside a clinical trial setting.  Additionally, the medical evidence supporting their use in any setting is very limited.  

The measurement of hemoglobin A1c (HbA1c, a glycosolated hemoglobin) levels is a standard measure of blood glucose control over time. It is routinely used to evaluate and direct diabetic care and control of HbA1c concentrations is related to complications and outcomes in patients with diabetes.  The 2007 American Diabetes Association (ADA) Standards of Medical Care in Diabetes recommend that HbA1c be tested at least twice a year in diabetics who are meeting treatment goals and whose therapy is stable, and quarterly in those who are not meeting goals or whose therapy is changing.  These recommendations are based on expert consensus or clinical experience.  There is no evidence to suggest that more frequent HbA1c measurement is helpful in the management of patients with diabetes.
  
Unlike home glucose monitoring which gives an instantaneous reading of blood sugar levels at a single point in time and is used to alter diabetic treatment in real time, measurement of HbA1c is an indicator of blood glucose control over a long period of time and the recommended frequency of testing is in the range of every 3 or 6 months depending on control.  Thus, there is no value in measuring HbA1c multiple times in the course of a day or week. Finally, home HbA1c monitoring has not been established to have any role in diabetes care and no authoritative organization recommends such testing.

Diabetes is characterized by high blood sugar levels related to problems with the body’s ability to react to or produce insulin, a substance created in the pancreas.  Insulin is a vital part of the body’s mechanism for using blood glucose to produce energy.  According to the American Diabetes Association, approximately 17 million people in the United States have diabetes.  An estimated 11.1 million people have been diagnosed while 5.9 million people are unaware that they have the disease.

There are three major types of diabetes:

• Type 1 diabetes, formerly known as Juvenile Diabetes, is a condition where the body does not produce insulin, requiring the injection of insulin from other sources in order to maintain normal blood glucose levels.
• Type 2 diabetes is a condition where the body’s cells do not effectively use the insulin that is present in the blood and/or there is a progressive inability to produce adequate levels of insulin.  Approximately 90-95% of patients with diabetes are type 2, making this the most common form of diabetes.
• Gestational diabetes is a condition where blood glucose levels become elevated during pregnancy in women who normally do not have blood sugar problems. This type of diabetes affects about 4% of all pregnant women and the cause remains unknown.  In the majority of cases, there is a return to normal blood glucose levels after delivery.

Diabetes may lead to very serious health problems including an increased risk for heart attack, stroke, and complications related to poor circulation such as nerve damage, kidney failure, and blindness. One of the most common complications of diabetes is diabetic neuropathy or damage to the nerves.  Problems may develop in the feet from nerve damage as a result of neuropathy or from poor blood flow. Patients with diabetes are also at a higher risk for gum disease and other mouth-related problems.  Careful regulation and monitoring of blood glucose levels have been shown to prevent or slow the progression of these and other diabetes-related conditions.

Blood Glucose Monitors

A blood glucose monitor is a portable battery-operated meter used to determine the level of blood sugar (glucose).  Using a lancet, the individual obtains a drop of blood, which is placed on a special strip and inserted into the machine.  The monitor determines the blood glucose level, and a numerical reading is displayed.  Based on the glucose level, the individual may adjust his/her medication or eating habits within the limits set by the physician.

Blood glucose monitoring systems are also available for use by patients who are visually impaired.  These monitors have special voice synthesizers, timers, and specific supplies to enable visually impaired patients to use the equipment without assistance.  Other monitors feature components that can connect to a personal computer and graph blood sugar readings over time.

There are many new nonstandard forms of glucose monitors; among them are monitors that do not require a drop of blood but can "read" glucose levels through the skin, and small, implanted sensors that can monitor glucose levels every 5 minutes for three days.  One monitor, the Duet system, can monitor blood glucose as well as fructosamine protein levels, another indicator of blood sugar levels.

Interstitial Glucose Monitors

Devices are now available that continuously monitor the glucose concentrations in the fluid in between the body’s cells, also known as interstitial fluid.  The devices function on the scientific principle of using a glucose oxidase enzyme reaction to measure glucose. The continuous monitoring of glucose levels has been proposed as an important adjunct to blood glucose monitoring in patients with diabetes who suffer from undetected hypoglycemic events or with brittle control of their blood glucose levels, despite optimal care. The continuous monitoring devices are designed to electronically store the data collected for later downloading to a computer for trend analysis by a physician. These data sets may be used to identify ways to improve patient care by altering diet, exercise, or medication types or timing. 

These devices may be divided into two categories, invasive and non-invasive, based on method to obtain the fluid. Additionally, while these devices may seek similar information, they differ in the methods and timing of data set collection, the demonstrated accuracy of information, and the ability to use information as independent findings without corroboration by standard monitoring.

• Invasive devices
  
  At the time of this writing, there are three invasive monitoring devices commercially available: the Continuous Glucose Monitoring System (CGMS®), the Guardian® RT device, and the DexCom™ STS™ Continuous Interstitial Glucose Monitor. A fourth device, the MiniMed Paradigm® REAL-Time System combines an insulin pump with the Guardian RT monitor.  These devices use an invasive subcutaneous probe to continuously monitor interstitial glucose.  Data from the CGMS sensor is transmitted via a cable and recorded in a pager-sized data-recording device that can be worn on a belt.  The Guardian RT and DexCom devices use a wireless radio transmitter system to send data from the interstitial monitor to the data collection device.  Both the Guardian and the DexCom are also equipped with real-time data display and an alarm function that is proposed to alert patients when detected glucose levels fall below a threshold level.  These devices are intended to be used continuously and long-term for the management of diabetes.

• Non-invasive devices
  
  At the time of this writing, there is one non-invasive monitoring device commercially available, the GlucoWatch Biographer G2, commonly referred to as the GlucoWatch®.  This device is worn like a wristwatch and uses an adhesive electrode in a process of reverse iontophoresis to extract interstitial fluid through the skin for analysis. The GlucoWatch is equipped with an alarm function intended to alert patients when glucose levels fall out of a set range.
  
  The GlucoWatch is proposed as a tool to monitor interstitial glucose concentrations in real time in addition to providing retrospective data. The device is intended to be worn 2-4 times a week for several hours, up to a 12-hour period, during the day or night.  The device has a readout feature displaying the most recent glucose measurement, with new readings every 20 minutes.  The device can be operated by the patient and is intended for long-term use.
  
  In addition to storing readings, the GlucoWatch automatically compares each new glucose value with high and low alarm ranges that may be set and adjusted by the patient, with or without the advice of medical professionals.  An alarm may sound when readings are beyond pre-set range levels.  However, patients are advised they must not rely on the GlucoWatch to alert them every time their glucose may be too high or too low.  Patients are also advised not to change treatment based only on GlucoWatch results.  Instead, they are instructed to check their blood glucose level and make treatment decisions based on standard monitoring.  The primary function of the alert feature is to identify a possible need for obtaining a glucose level between regularly scheduled blood glucose monitoring times.

Other Glucose Monitoring Devices

There are other interstitial glucose monitoring devices currently under investigation that use other methods of glucose collection and analysis.  These devices have yet to receive approval by the Food and Drug Administration.

Hemoglobin A1c Measurement

The measurement of certain glycosylated serum proteins had been used as an indicator of long-term blood sugar concentrations and control.  The most important of these is hemoglobin A1c (HbA1c).  The current American Diabetes Association (ADA) guidelines for the monitoring of HbA1c recommends HbA1c measurements at least two times a year in patients who are meeting treatment goals (and who have stable glycemic control) and quarterly in patients whose therapy has changed or who are not meeting glycemic goals (ADA, 2007). The ADA has set a HbA1c concentration of 7% as the goal for patients with diabetes.  When a patient has a measurement greater than 7% it is an indicator that the patient’s blood sugar concentrations are not adequately controlled under their current care regimen and alterations in their diet, exercise level and drug regimen is warranted. 

Blood Glucose: a sugar that is present in the bloodstream

DexCom™ STS™ Continuous Interstitial Glucose Monitor: a device that measures the sugar concentration in fluid in between cells below the skin as an aid in diabetes management; this device features an alarm function, digital real-time readout and a cordless data-recoding device

Fingersticks: a process where a patient with diabetes uses a sterile lancet to prick their finger for the purpose of drawing blood for blood glucose measurements

Fructosamine: molecules formed by the linking of blood sugars onto protein molecules in the bloodstream; this process is affected by the levels of blood glucose and has been proposed as an indicator of blood glucose levels over a few weeks’ time

Glucose: a form of sugar required for proper functioning of the body

GlucoWatch®: a device resembling a watch that is designed to measure interstitial glucose by drawing interstitial fluid out of the skin

Glycemic Control: control of blood glucose levels

Hemoglobin A1c (HbA1c): a protein in red blood cells that on occasion bonds with glucose in the blood; measurements of hemoglobin A1c concentrations are used as an indicator of a person's average blood glucose level for the span of the cell’s life (about 4 months)

Hyperglycemia: blood glucose levels higher than the normal range

Hypoglycemia: blood glucose levels lower than the normal range

Impaired Glucose Tolerance (IGT) (also known as 'Impaired Fasting Glucose' or 'Pre-Diabetes'): a condition that occurs when a person's blood glucose levels are higher than normal but not high enough for a diagnosis of diabetes

Infrared Spectroscopy: a method proposed for the measurement of blood glucose levels using an infrared light-based device

Insulin: a substance normally produced by the body that takes glucose from the blood and makes glucose usable by the cells of the body

Interstitial Glucose: glucose that is found in the fluid between cells, outside the blood vessels

Invasive: involving puncture or incision of the skin

Minimed Continuous Glucose Monitoring System: (also known as CGMS®): a device designed to measure interstitial glucose using a small electrode temporarily inserted into the skin

MiniMed Guardian RT®: a device similar to the Minimed Continuous Glucose Monitoring System, but containing an alarm function and cordless data-recoding device

MiniMed Paradigm® REAL-Time System: a device that combines an insulin pump and an invasive continuous interstitial glucose monitor

Non-invasive: not involving puncture or incision of the skin

The following codes for treatments and procedures applicable to this policy are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Medically Necessary:

HCPCS

ICD-9 Diagnosis

When services are Not Medically Necessary:

HCPCS

ICD-9 Diagnosis

II.  Continuous Glucose Monitoring

Services may be Medically Necessary, when criteria are met:

CPT

ICD-9 Diagnosis

When services are Investigational/Not Medically Necessary:

For the procedure and diagnosis codes listed above, when criteria are not met, for all other diagnoses not listed, or when the code describes a procedure indicated in the Policy section as investigational/not medically necessary

Services are also Investigational/Not Medically Necessary:

HCPCS

ICD-9 Diagnosis

III.  Glycated Serum Protein Monitoring

When services are Investigational/Not Medically Necessary:

HCPCS

ICD-9 Diagnosis

Peer Reviewed Publications:

1. Bantle JP, Thomas W. Glucose measurement in patients with diabetes mellitus with dermal interstitial fluid. J Clin Lad Med. 1997; 130:436-441.
2. Bode BW. Clinical utility of the continuous glucose monitoring system. Diabetes Tech Therapeutics. 2000; 2(S1):S35-S41.
3. Bode BW.  Using the continuous glucose monitoring system to improve the management of type 1 diabetes. Diab Tech Therapeutics. 2000; 2(S1):S43-S48.
4. Bode B, Gross K, Rikalo N, et al. Alarms based on real-time sensor glucose values alert patients to hypo-and hyperglycemia: The guardian continuous monitoring system. Diabetes Technol Ther. 2004; 6(2):105-113.
5. Bode W, Gross TM, Thornton KR, Mastrototaro JJ. Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: A pilot study. Diabetes Res Clin Pract. 1999; 46:183-190.
6. Boland E, Monsod T, DeLecia M, et al. Limitations of conventional methods of self-monitoring of blood glucose. Diabetes Care. 2001; 24:1858-1862.
7. Cagliero E, Levina EV, Nathan DM. Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients. Diabetes Care. 1999; 22(11):1785-1789.
8. Chase HP, Wightman C, Klingensmith G, et al. Use of the GlucoWatch in children with type I diabetes.  Pediatrics. 2003; 111:790-794.
9. Chase HP, Kim LM, Owen SL, et al. Continuous glucose monitoring in children with type 1 diabetes. Pediatrics. 2001; 107:222-226.
10. Chase HP, Roberts MD, Wightman C, et al. Use of the glucowatch biographer in children with Type 1 diabetes. Pediatrics. 2003; 111(4 Pt 1):790-794. 
11. Cheyne EH, Cavan DA, Kerr D. Performance of a continuous glucose monitoring system during controlled hypoglycemia in health volunteers.  Diabetes Tech Therapeutics. 2002; 4(5):607-613. 
12. Deiss D, Bolinder Jan, Jean-Pierre Riveline J, et al. Improved glycemic control in poorly controlled patients with type 1 diabetes using real-time continuous glucose monitoring. Diabetes Care. 2006; 29:2730-2732.
13. Diabetes Research in Children Network (DirecNet) Study Group. Accuracy of the glucowatch G2 biographer and the continuous glucose monitoring system during hypoglycemia: experience of the Diabetes Research in Children Network. Diabetes Care. 2004; 27(3):722-726. 
14. Diabetes Control and Complication Trial Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes. NEJM. 1993; 329:977-986.
15. Eastman RC, Chase HP, Buckingham B, et al. Use of the GlucoWatch biographer in children and adolescents with diabetes. Ped Diabetes. 2002; 3:127-134.
16. Faas A, Schellevis FG, vanEijk JT. The efficacy of self-monitoring of blood glucose in NIDDM subjects: A criteria based literature review. Diabetes Care. 1997; 20:1482-1486.
17. Ferenczi A, Reddy K, Lorber DL. Effect of immediate hemoglobin A1c results on treatment decisions in office practice. Endocr Pract. 2001; 7(2):85-88.
18. Fineberg SE, Bergenstal RM, Bernstein RM, et al. Use of an automated device for alternative site blood glucose monitoring. Diabetes Care. 2001; 24(7):1217-1220. 
19. Fox L, Ditched M, Reedy K, et al.: DirecNet Study Group. Relative inaccuracy of the A1cNow in children with type 1 diabetes. Diabetes Care. 2007; 30(1):135-137.
20. Gandrud LM, Paguntalan HU, Van Wyhe MM, et al. Use of the Cygnus GlucoWatch biographer at a diabetes camp. Pediatrics. 2004; 113(1 Pt 1):108-111. 
21. Garg SK, Potts Ro, Ackerman, NR, et al. Correlation of fingerstick blood glucose measurements with GlucoWatch biographer glucose results in young subjects with Type 1 diabetes. Diabetes Care. 1999; 22(10):1708-1714. 
22. Garg SK, Schwartz S, Edelman SV. Improved glucose excursions using an implantable real-time continuous glucose sensor in adults with type 1 diabetes. Diabetes Care. 2004; 27(3):734-738. 
23. Garg S, Zisser H, Schwartz S, et al.  Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor: a randomized controlled trial. Diabetes Care. 2006; 29(1):44-50.
24. Gross TM, Ter Veer A. Continuous glucose monitoring in previously unstudied population groups. Diabetes Tech Therapeutics. 2000; 2(S1):S27-S34.
25. Gross TM, Mastrototaro JJ. Efficacy of the Continuous Glucose Monitoring System. Diabetes Tech Therapeutics. 2000; 2(S1):S19-S26.
26. Grieve R, Beech R, Vincent J, Mazurkiewicz. Near patient testing in diabetes clinics: Appraising the costs and outcomes.  Health Tech Assess. 1999; 3(13).
27. Hersch IB. Hypoglycemia and the hypoglycemic unawareness syndrome. Diabetes Tech Therapeutics. 2000; 2(S1):S81-S87. 
28. Jungheim K, Koschinsky T. Glucose monitoring at the arm: risky delays of hypoglycemia and hyperglycemia detection. Diabetes Care. 2002; 25(6):956-960. 
29. Kaufman FR, Gibson LC, Halvorson M, et al. A Pilot study of the Continuous Glucose Monitoring System. Diabetes Care. 2001; 24:2030-2034.
30. Kaufman FR, Austin J, Neinstein A, et al. Nocturnal hypoglycemia detected with the Continuous Glucose Monitoring System in pediatric patients with Type 1 diabetes. Pediatrics. 2002; 141(5):625-630.
31. Kennedy L, Herman WH; GOAL A1C Study Team. Glycated hemoglobin assessment in clinical practice: comparison of the A1cNow point-of-care device with central laboratory testing (GOAL A1C Study). Diabetes Technol Ther. 2005; 7(6):907-912. 
32. Kennedy L, Herman WH, Strange P, Harris A; GOAL AIC Team.  Impact of active versus usual algorithmic titration of basal insulin and point-of-care versus laboratory measurement of HbA1c on glycemic control in patients with type 2 diabetes: the Glycemic Optimization with Algorithms and Labs at Point of Care (GOAL A1C) trial. Diabetes Care. 2006; 29(1):1-8.
33. Klonoff DC. The need for separate performance goals for glucose sensors in the hypoglycemic, normoglycemic, and hyperglycemic ranges. Diabetes Care. 2004; 27:834-836.
34. Little RR.  Analysis: point-of-care testing for glycated hemoglobin (GHB). Diabetes Technol Ther. 2005; 7(6):913-915.
35. Ludvigsson J, Hanas R. Continous subcutaneous glucose monitoring improved metabolic control in pediatric patients with type 1 diabetes: a controlled crossover study. Pediatrics. 2003; 111(5 Pt 1):933-938.
36. Metzger M, Leibowitz G, Wainstein J. Reproducibility of glucose measurements using the glucose sensor. Diabetes Care. 2002; 25:1185-1191.
37. Miller CD, Barnes CS, Phillips LS, et al. Rapid A1c availability improves clinical decision-making in an urban primary care clinic. Diabetes Care. 2003; 26(4):1158-1163.  
38. Monsod TP, Flanagan DE, Rife F, et al. Do sensor glucose levels accurately predict glucose concentrations during hypoglycemia and hyperinsulinemia? Diabetes Care. 2002; 25:889-893.
39. Petersen JR, Finley JB, Okorodudu AO, et al. Effect of point-of-care on maintenance of glycemic control as measured by A1C. Diabetes Care. 2007; 30(3):713-715.
40. Pitzer KR, Desai S, Dunn T, et al. Detection of hypoglycemia with the Glucowatch biographer. Diabetes Care. 2001; 24:881-885.
41. Potts Ro, Tamada JA, Tierney MJ. Glucose monitoring by reverse osmosis. Diabetes Metab Res Rev. 2002; 18(S1):S49-S53.
42. St John A, Davis TM, Goodall I, Townsend MA, Price CP. Nurse-based evaluation of point-of-care assays for glycated haemoglobin. Clin Chim Acta. 2006; 365(1-2):257-263.
43. Tanenberg R, Bode B, Lane W, et al. Use of the Continuous Glucose Monitoring System to guide therapy in patients with insulin-treated diabetes: a randomized controlled trial. Mayo Clin Proc. 2004 Dec; 79(12): 1521-6.
44. Tamada JA, Garg S, Jovanovic L, et al. Noninvasive glucose monitoring: Comprehensive clinical results. JAMA. 1999; 282(19): 1839-1844.
45. Tierney MJ, Tamada JA, Potts RO, et al. The GlucoWatch biographer: A frequent, automatic and non-invasive glucose monitor. Ann Med. 2000; 32:632-641.
46. Thaler LM, Ziemer DC, Gallina DL, et al. Diabetes in urban African-Americans. XVII. Availability of rapid HbA1c measurements enhances clinical decision-making. Diabetes Care. 1999; 22(9):1415-1421.
47. Tierney MJ, Tamada JA, Potts RO, et al.  Clinical evaluation of the GlucoWatch biographer: A continual non-invasive glucose monitor for patients with diabetes. Biosens Bioelectr. 2001; 16:621-629.
48. Yates K, Hasnat Milton A, Dear K, Ambler G. Continuous glucose monitoring-guided insulin adjustment in children and adolescents on near-physiological insulin regimens: a randomized controlled trial.  Diabetes Care. 2006; 29(7):1512-1517.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Agency for Healthcare Research and Quality. Point of care testing of hemoglobin A1c. August 30, 2005.  Available at:  http://www.cms.hhs.gov/mcd/viewtechassess.asp?where=index&tid=35. Accessed on April 11, 2007.
2. American Diabetes Association. Standards of Medical Care in Diabetes—2007. Diabetes Care. 2007; 30(Suppl 1):S4-S41.
3. American Diabetes Association. Gestational diabetes mellitus.  Diabetes Care. 2002; 26(Suppl 1):S103-105.
4. American Diabetes Association. Tests of Glycemia in Diabetes. Diabetes Care. 2002; 26(Suppl 1):S106-108.
5. American Diabetes Association. Third-Party Reimbursement for Diabetes Care, Self-Management Education, and Supplies Diabetes Care. 2002; 26(Suppl 1):S143-144.
6. American Diabetes Association. Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 2002; 26(Suppl 1):S5-20.
7. Blue Cross Blue Shield Association. Use of intermittent or continuous interstitial fluid glucose monitoring in patients with diabetes mellitus. Technology Evaluation Center Volume 18, No. 16.December 2003.
8. Canadian Coordinating Office for Health Technology. Continuous glucose monitoring in the management of diabetes mellitus. Issues in Emerging Health Technologies. May 2002; Issue 32.
9. Centers for Medicare and Medicaid Services. National Coverage Determination for Home Blood Glucose Monitors. NCD #40.2. Effective April 27, 1995.  Available at:  http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd. Accessed on March 30, 2007. 
10. Centers for Medicare and Medicaid Services. National Coverage Determination for Insulin Syringe. NCD #40.4. Effective date not posted. Available at:  http://www.cms.hhs.gov/mcd/index_list.asp?list_type=ncd.   Accessed on March 30, 2007.
11. Hayes, Inc. Medical Technology Directory. Continuous glucose monitoring systems. Hayes Inc. Lansdale, PA. June 25, 2003.  Search updated February 28, 2007.

1. American Diabetes Association. Available at  www.diabetes.org. Accessed on March 30, 2007.

A1cNow +®
BioRad MicroMat^TM II HbA1c Monitor
Cholestech GDX^TM HbA1c Test
Continuous Glucose Management System® CGMS®
DexCom^TM STS-7® Continuous Glucose Monitoring System
DexCom™ STS™ Continuous Interstitial Glucose Monitor
DuoCare
GDX^TM HbA1c Test
GlucoWatch®
Glycosal II HbA1c test
Guardian® RT Continuous Glucose Monitoring System
Guardian® Telemetered Glucose Monitoring System (TGMS)
Metrika A1cNow +®
MicroMat^TM II HbA1c Monitor
Paradigm® REAL-Time System
Provalis Glycosal^TM II HbA1c Test
STS-7®

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member's contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by an means, electronic, mechanical, photocopying, or otherwise, without permission from the health plan.

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