Note: Except for Medicare plans and where coverage is mandated by state law, generally coverage for diabetic supplies would be provided under a pharmacy rider and not as part of medical coverage. Certain diabetic supplies may also be covered under the medical plan if no pharmacy or diabetic supplies rider is available. Please check plan benefits.

1. Diabetes Self-Care Programs:

   Aetna considers outpatient medical self-care programs medically necessary for persons with diabetes when such programs meet the following criteria:

   1. The program is ordered by the physician treating the member's diabetes and includes a statement signed by the physician that the service is needed; and
   2. The program consists of services of recognized healthcare professionals (e.g., physicians, registered dieticians, registered nurses, registered pharmacists); and

   3. The program is designed to educate the member about medically necessary diabetes self-care.

2. Diabetic Supplies:

   The following diabetic supplies are considered medically necessary:

   1. Blood glucose monitors;
   2. Needles and syringes for insulin administration;
   3. Insulin pens;
   4. Blood glucose test strips;
   5. Urine test tablets/strips;
   6. Lancets;
   7. Control solutions; and
   8. Alcohol swabs.

   Note: Coverage of diabetic supplies varies by medical and pharmacy plan. Please check plan documents for details.

3. Lasette™ Laser Blood Glucose Monitoring Device:

   Aetna considers the Lasette laser blood glucose monitoring device (Cell Robotics International Inc., Albuquerque, NM), which uses a laser instead of a lancet to perforate the skin to obtain a blood sample for glucose measurement, experimental and investigational. There is insufficient evidence in the peer reviewed medical literature that laser skin perforation offers clinically significant advantages over standard lancets.

4. Glycated Serum Proteins (GSP):

   Aetna considers devices to measure glycated serum proteins (fructosamine) (e.g., Duet™ Glucose Control System by LXN Corporation) experimental and investigational. 

5. Glutamic Acid Decarboxylase (GAD) Autoantibodies:

   Aetna considers measurement of autoantibodies to GAD medically necessary for distinguishing type 1 from type 2 diabetes when the clinical history is ambiguous and the results of testing will influence patient management. Measurement of anti-GAD antibodies is also considered medically necessary in diagnosing stiff-person syndrome. Anti-GAD antibody measurement is considered experimental and investigational for predicting the onset of diabetes and for all other indications.

6. Jet Injectors:

   Aetna considers jet injectors (e.g., Vita-Jet II, Advanta Jet, Freedom Jet, Medi-Jector EZ, Biojector 2000) medically necessary durable medical equipment (DME) when the member or the member's caregiver is physically unable to use a conventional needle-syringe. The use of jet injectors for other reasons is considered a matter of preference and convenience.

7. I-Port:

   Aetna considers the I-Port Injection Port (Patton Medical) a noncovered convenience item.

8. Continuous Glucose Monitoring Devices:

   Aetna considers continuous glucose monitoring devices (e.g., MiniMed Continuous Glucose Monitoring System, Guardian Real-Time Continuous Glucose Monitoring System, and the DexCom STS), which are used to continuously monitor diabetic persons' blood glucose levels over a three-day (72-hour) period, medically necessary for persons with type 1 diabetes who have either of the following problems in controlling blood glucose level, unresponsive to conventional insulin dose adjustment:

   1. repeated hypo- and hyperglycemia at the same time each day; or

   2. hypoglycemia unawareness.

   No more than two CGMS monitoring periods are considered medically necessary within a 12-month period.

   Aetna considers the long-term use of continuous glucose monitoring devices medically necessary as an adjunct to fingerstick testing of blood glucose in persons with type 1 diabetes who have had recurrent episodes of severe hypoglycemia (blood glucose less than 50mg/dL) despite appropriate modifications in insulin regimen and compliance with frequent self-monitoring (at least four fingersticks per day). Long-term use of continuous glucose monitoring devices are considered experimental and investigational for all other indications.

9. Biostator® Artificial Pancreas:

10. Aetna considers the Biostator System, a device which functions as an artificial pancreas, experimental and investigational. There are insufficient data in the published peer-reviewed medical literature documenting the safety and effectiveness of the Biostator.

11. GlucoWatch® Biographer Monitor:

    Aetna considers the GlucoWatch Biographer (Cygnus Inc, Redwood City, CA.), a glucose meter that is worn on the wrist, experimental and investigational.

12. Blood Glucose Meters with Electronic Voice:

    Aetna considers reflectance meters with an electronic voice medically necessary DME only for legally blind (best corrected visual acuity less than 20/200) persons with diabetes.

13. Alternate Site Blood Glucose Monitors:

    Aetna considers alternate site blood glucose monitors medically necessary DME for the following persons with diabetes, when an alternate site blood glucose monitor is recommended by their physician:

    1. Children below age of 12 years; or
    2. Persons who have used conventional blood glucose meters for at least 1 month (more than 30 days) and who have been noncompliant with blood glucose testing because of pain sensitivity or heavily callused fingertips.

    Alternate site blood glucose monitors have no proven value over standard blood glucose monitors for other indications.

14. Home Glycated Hemoglobin Monitors:

    Aetna considers home glycated hemoglobin (HbA1c or A1C) monitors (e.g., A1cNow Diabetes Monitor, Metrika Inc., Sunnyvale, CA) experimental and investigational. There are no prospective clinical studies demonstrating improvements in compliance or other clinically significant benefits of home A1C testing over laboratory A1C testing.  Individual-case exceptions to this policy may be made upon medical review for members who are unable to access laboratory A1C testing.

15. Personal Digital Assistant-Based Blood Glucose Monitor:

    Aetna considers a personal-digital assistant-based blood glucose monitoring devices (e.g., TheraSense FreeStyle Tracker, Accu-Check Advantage Module) and module experimental and investigational because they have not been shown in published clinical studies to improve clinical outcomes over standard blood glucose monitors. (Note: A personal digital assistant (PDA) does not meet Aetna's definition of covered durable medical equipment in that the PDA can be used in the absence of illness or injury.)

16. ReliOn NewTek Disposable Blood Glucose Monitor:

    Aetna considers a disposable blood glucose monitor (e.g., the ReliOn NewTek (Hypoguard USA, Inc., Edina, MN)) an acceptable medically necessary alternative to a standard blood glucose monitor.

17. Insulin Infusion Pumps:

    For clinical policy on insulin infusion pumps, please see CPB 161 - Infusion Pumps.

Glycated Serum Proteins (Fructosamine)

Aetna considers devices to measure glycated serum proteins (fructosamine) (e.g., Duet™ Glucose Control System by LXN Corporation) experimental and investigational. The fructosamine test measures the average of continuous glucose levels over the prior 2-3 week period, and is being marketed as an indicator of overall glucose control in diabetics. The American Diabetes Association has determined that measurement of glycated serum protein should not be considered the equivalent of measurement of glycated hemoglobin, and that the clinical utility of monitoring GSP has yet to be established.   A randomized clinical trial (Petitti et al., 2001) of 140 patients with diabetes found that patients randomized to home fructosamine monitoring had higher levels of HbA1c after 3 and 6 months of follow-up.  In a review of GSP and diabetes, Goldstein (1997) concluded that “further studies are recommended to determine whether the use of GSP to document short-term changes (e.g., 1 to 2 weeks) in glycemic status is clinically useful”.

Glutamic Acid Decarboxylase (GAD-65) Antibodies

Glutamic acid decarboxylase (GAD) is an enzyme that is produced primarily by pancreatic islet cells. A number of recent studies indicate that patients with type 1 diabetes often have antibodies to GAD and several other islet cell antigens. This is consistent with the hypothesis that type 1 diabetes is an autoimmune disease and that autoantibody production is an early step in the development of type 1 diabetes.  Autoantibodies can be detected in many cases prior to the onset of glucose intolerance. The presence of GAD autoantibodies has been shown to be a strong predictive marker for the eventual onset of type 1 diabetes.

Measurement of anti-GAD antibodies has been proposed for evaluating the risk of developing type 1 diabetes in persons at high risk. However, the value of such testing is unproven, as there are no measures that have been demonstrated to be effective in preventing the onset of type 1 diabetes. Guidelines from the Canadian Diabetes Association (Ur, et al., 2003) explain that the loss of pancreatic beta cells in persons who subsequently develop type 1 diabetes passes through a subclinical prodrome that can be detected reliably in first- and second-degree relatives of persons with type 1 diabetes by the presence of anti-GAD antibodies and other pancreatic islet cell autoantibodies in their sera. While randomized trials testing prevention strategies have been completed or are now underway, safe and effective preventive strategies have not been identified. The guidelines conclude: "Therefore, any attempts to prevent type 1 diabetes should be undertaken only within the confines of formal research protocols."

Measurement of anti-GAD antibody can be of use in distinguishing type 1 from type 2 diabetes when the clinical history is ambiguous. Guidelines from the Royal Australian College of General Practitioners (RACGP, 2007) explain that measurement of GAD can be of of particular use in diagnosing Late onset Autoimmune Diabetes in Adults (LADA), a form of late onset diabetes that is autoimmune and requires treatment with insulin within a relatively short period of time after diagnosis (often within the next two years). RACGP guidelines explain that persons with LADA tend to be young (30 to 40 years of age, lean, and have a personal and/or family history of other autoimmune diseases (e.g., hypo- or hyperthyroidism). The guidelines state that testing for GAD antibodies can confirm the diagnosis in ambiguous cases and prompt counsling the person about the likely time course of diabetes progression and the possibility of other autoimmune disease. In addition, the establishment of the LADA diagnosis may be useful in selecting therapy (Brophy, et al., 2007)

Antibodies to GAD are often markedly elevated in patients with the stiff-person syndrome (also referred to as stiff-man syndrome), a condition that is associated with fluctuating stiffness and paroxysmal spasms of the trunk and legs.

Jet Injectors

Jet injectors offer an alternative method of hypodermic drug delivery from conventional needle-syringe.  The main objective in using a jet injector as opposed to conventional needle-syringe is for increased patient comfort during injection.  A review of the literature indicates some patients do prefer injection by jet injector while others may experience more discomfort.  The Youth Task Force of the American Diabetes Association (Task Force on Jet Injections, 1998, 1991) reviewed the scientific literature on jet injection and could not make general recommendations for their use due to insufficient information. There are hypothetical risks and benefits associated with their use for insulin delivery which have not been clearly addressed in the literature.  There is insufficient information on the frequency and significance of aversion to needles, therefore, the use of jet injectors because of a fear of needles is a matter of convenience and patient preference.  A jet injector may be appropriate for some individuals with medical conditions that make it impossible for them to use a conventional needle-syringe.. Which group of patients unable to use syringes and who are therefore candidates for jet injections based on medical necessity has not been defined in the literature, but reasonably includes individuals with severe arthritis, severe tremors, or blindness.

I-Port Injection Port

The I-Port Injection Port (Patton Medical, Austin, TX) is an insulin delivery port which is used to reduce the number of needle injections of insulin. The I-Port is applied using an insertion needle to guide a soft cannula into the subcutaneous tissue. Once applied, the insertion needle is removed, leaving the soft cannula under the skin, acting as the gateway into the subcutaneous tissue. To inject through the I-Port, the needle of a syringe or insulin pen is used. The needle remains above the surface of the skin, while the medication is idelivered through the soft cannula into the subcutaneous tissue. According to the manufacturer, the I-Port can accommodate 75 injections, and be worn for up to 72 hours. The I-Port was cleared by the U.S. Food and Drug Administration based upon a 510(k) application. There is no peer-reviewed published data on the safety and effectiveness of the I-Port. Clinical studies are necessary to evaluate the I-Port's impact on compliance and other clinical outcomes.

Continuous Glucose Monitors

The U.S. Food and Drug Administration (FDA) granted the MiniMed CGMS (Medtronic MiniMed, Minneapolis, MN) pre-market approval in June 1999 for use as an adjunct to finger-stick blood glucose testing. The MiniMed CGMS consists of a subcutaneously implanted glucose sensor and monitor that can record glucose values every 5 minutes for up to three days. While in operation, the MiniMed CGMS monitor does not display glucose values, and individuals are still required to test their glucose levels several times a day by a standard method (finger sticks) and enter the glucose measurements into the monitor for calibration purposes. According to the FDA, the MiniMed CGMS is not intended to replace standard finger-stick testing.

More recently, the FDA approved the Guardian Real-Time (RT) Continuous Glucose Monitoring System (Medtronic, Minneapolis, MN), which is described by the manufacturer as the first consumer continuous glucose monitoring device. According to the manufacturer, the device provides up to 288 glucose readings per day or every 5 minutes. According to the FDA-approved labeling, the Guardian RT is indicated to supplement blood glucose information from standard home blood glucose meters, for persons 18 years and older with type 1 or type 2 diabetes. A fingerstick measurement is required before taking action.

The DexCom STS Continuous Glucose Monitoring System (DexCom, Inc., San Diego, CA) gained FDA approval on March 24, 2006.  It is a glucose sensor that reports glucose values every 5 minutes for up to 72 hours.  These readings are used with fingerstick results to detect trends and patterns in glucose levels in adults with diabetes, aged 18 years and over.  The DexCom STS is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.

The Paradigm Real Time System (Medtronic Minimed) is an open-loop insulin delivery system that combines an external insulin pump with continuous monitoring of interstitial glucose levels via a subcutaneous sensor. The sensor communicates glucose readings to the pump using a radio transmitter. The pump can also calculate recommended insulin doses, which the patient can accept or modify. Readings from the CGMS are not intended to be used to make therapy adjustments. A conventional blood glucose meter reading is needed before making adjustments because there is a lag of up to 10 minutes in glucose concentration in the interstitial fluid relative to the concentration in the blood (CADTH, 2007). Furthermore, readings from the sensor may be less accurate in the hypoglycemic range. An assessment of the Paradigm Real Time System by the Canadian Agency for Drugs and Technologies in Health (CADTH, 2007) concluded: "Based on the limited amount of research published to date, the impact of the Paradigm Real-Time System on long-term glycemic control, prevention of diabetic
complications, or quality of life is unclear." The assessment noted that open-loop systems such as the Paradigm Real Time System are an incremental step towards a fully closed-loop system, also known as an artificial pancreas, where insulin dosages would be automatically adjusted, rather than requiring patient input.

Guidelines from the National Institute for Health and Clinical Excellence (2004) recommend the use of continuous glucose monitoring devices for the evaluation of persons with type 1 diabetes on insulin therapy who have "repeated hypo- and hyperglycaemia at the same time each day, and hypoglycaemia unawareness, unresponsive to conventional insulin dose adjustment."

There is insufficient evidence to support the prolonged use of continuous glucose monitoring devices as an adjunct to home blood glucose monitoring for improving long-term glycemic control. The potential advantages of adjunctive use of continuous glucose monitoring devices in managing persons with poorly controlled diabetes are theoretical. There are no adequate prospective clinical studies in the peer-reviewed published medical literature demonstrating that the use of continuous glucose monitoring devices results in durable improvements in outcomes of individuals with diabetes. 

The largest clinical study of CGMS performed to date, with 400 patients, found that continuous blood glucose monitoring had no durable effect on blood glucose control. The findings from the Minimally Invasive Technology Role and Evaluation (MITRE) study, sponsored by the National Institute for Health Research Health Technology Assessment Program, were presented at the American Diabetes Association 67th Scientific Sessions on July 9, 2007 (Newman, et al., 2007)  The purpose of the MITRE study was to evaluate the efficacy of minimally invasive glucose monitoring devices in patients with diabetes mellitus treated with insulin. The primary endpoint was long-term glucose control, as indicated by changes in glycosylated hemoglobin (HbA1c) levels for 18 months. Four hundred patients were randomly assigned to the CGMS by MiniMed, the Biographer by Animas, a standard control or to an attention control group. Mean baseline HbA1c ranged from 7.0%-15.5% for participants. All groups demonstrated a decline in mean HbA1c, especially during the first few months of the study. However, by month 18, the percentage of patients that had a relative reduction of at least 12.5% was 15% in the Biographer group, 27% in the CGMS group, 24% in the standard control, and 27% in the attention control group. The relative decline in HbA1c from baseline ranged from 1% to 4.6%. The results suggest that the use of the CGMS had a small benefit, but only in the short term, and that the Biographer had less impact on HbA1c than either the CGMS or standard treatment.

A recently published systematic evidence review and metaanalysis of the evidence for continuous glucose monitoring systems in children with type 1 diabetes reached the following conclusions (Golicki, et al., 2008): "The Continuous Glucose Monitoring System is not better than self-monitoring of blood glucose with regard to improvement of metabolic control among type 1 diabetic children. However, due to the small number of participants and methodological limitations of the studies included, findings of this meta-analysis should be interpreted with caution."

Regarding the therapeutic use of continuous glucose monitoring devices for hypoglycemic unawareness, current evidence from randomized controlled clinical trials have focused on CGMS' effect on shortening the duration of asymptomatic hypoglycemia, an intermediate endpoint, rather than clinical outcomes. The clinical significance of reductions in duration of asymptomatic hypoglycemia are unknown. In addition, current evidence indicates that continuous glucose monitoring devices are least accurate in the hypoglycemic range (CADTH, 2007; Melki, et al., 2006).

Hypoglycemia unawareness is reversible. Meticulous avoidance of hypoglycemia for several weeks is sufficient to restore awareness of hypoglycemia (Cheng, et al., 2000; Fanelli, et al., 1993; Dagogo-Jack, et al., 1994; Cranston, et al., 1994). The return of awareness is accomplished with minimal compromise of glycemic control, but that required substantial involvement of health professionals. In addition, unlike CGMS, HAATT/BGAT (Hypoglycemia Anticipation, Awareness and Treatment Training/ Blood Glucose Awareness Training) has been proven to reduce the occurrence of severe hypoglycemia (Cox, et al., 2004; Cox, et al., 2001).

Guidelines from the American Diabetes Association (2008) state that "continuous glucose monitoring may be a supplemental tool to SMBG [self-monitoring of blood glucose] for selected patients with type 1 diabetes, especially those with hypoglycemia unawareness." The guidelines state that this recommendation is based upon expert opinion rather than clinical studies. The ADA guidelines explain: "In recent years, methods to sample interstitial fluid glucose (which correlates highly with blood glucose) in a continuous and minimally invasive way have been developed. Most microdialysis systems are inserted subcutaneously, while an early system employed “reverse iontophoresis” to move glucose across the skin. The concentration of glucose is then measured by a glucose oxidase electrode detector. These systems require calibration with SMBG readings, and the latter are still recommended for making treatment decisions. Continuous glucose sensors have alarms for hypo- and hyperglycemia. Small studies in selected patient populations have shown good correlation of readings with SMBG and decreases in the mean time spent in hypo- and hyperglycemic ranges compared with blinded sensor use. Although continuous glucose sensors would seem to show great promise in diabetes management, as yet no rigorous controlled trials have demonstrated improvements in longterm glycemia."

A structured review of the evidence conducted by the BlueCross BlueShield Association Technology Evaluation Center (2003) concluded that “use of intermittent or continuous interstitial fluid glucose monitoring in patients with diabetes mellitus does not meet Blue Cross and Blue Shield Association Technology Evaluation Center criteria.” Similarly, a technology assessment conducted by the California Technology Assessment Forum (CTAF) concluded that CGMS does not meet CTAF's criteria (Tice, 2003). A draft technology assessment of self-monitoring of blood glucose in persons with type 2 diabetes prepared for the Centers for Medicare and Medicaid Services (Balk, et al., 2006) commented that “currently, CGM [continuous glucose monitoring] has been studied primarily in children with type 1 diabetes. It is unclear whether CGM provides added value to traditional SMBG [self monitoring of blood glucose].”

The American Diabetes Association (2007) concluded that there is insufficient evidence to support the use of CGMS in the hospital setting: "The introduction of real-time blood glucose monitoring as a tool for outpatient diabetes management has potential benefit for the inpatient population. However, at this time, data are lacking examining this new technology in the acutely ill patient population. Until more studies are published, it is premature to use continuous blood glucose monitoring except in a research setting."

A major limitation of CGMS is the durability and stability of the glucose sensors. Interstitial glucose concentrations, obtained with subcutaneous sensors, correlate with blood glucose concentrations. However, the sensors become progressively less accurate over time, so they cannot be used on a maintenance basis, and must be changed every three days. Another potential concern is the six to ten minute delay in interstitial glucose sensor response to changes in serum glucose levels. This delay appears to be most important when glucose levels are falling rapidly, since it might result in development of clinically significant hypoglycemia before it was reflected in the sensor reading.

Artificial Pancreas

Aetna considers the Biostator System, a device which functions as an artificial pancreas, experimental and investigational. The Biostator is a glucose-controlled insulin infusion system developed in the early 1980's for use by a physician trained in the device. There are insufficient data in the published peer-reviewed medical literature documenting the safety and effectiveness of the Biostator. The Biostator is mainly used in research; it is rarely used in clinical practice.

GlucoWatch Biographer

Aetna considers the GlucoWatch Biographer (Cygnus Inc, Redwood City, CA.), a glucose meter that is worn on the wrist, experimental and investigational. The GlucoWatch Biographer provides noninvasive continuous glucose measurements, and is intended to detect trends in glucose levels in persons with diabetes. GlucoWatch measures the concentration of glucose by iontophoresis; a constant low-level electrical current is conducted through the skin, which causes glucose to be transported across the skin where it can be measured. After a three-hour warm-up period and calibration from a finger stick blood measurement, the device can provide up to three non-invasive glucose measurements per hour for up to 12 hours. Readings can be stored for several months and can be downloaded into a computer. Clinical studies (Garg, et al., 1999; Tamada, et al., 1999) have reported correlations between GlucoWatch readings and standard finger-stick blood glucose measurements.

Because clinical studies show that the GlucoWatch is less accurate than finger-stick testing, the device does not eliminate the need for painful finger-sticks. In studies submitted to the FDA, measurements differed from finger-stick results by more than 30 percent up to one-third of the time. The GlucoWatch won't measure blood glucose levels if the person perspires excessively, and is less effective at detecting life-threatening low blood sugar than at spotting dangerously high glucose levels. According to the FDA-approved labeling, the GlucoWatch is intended to supplement, not replace, standard finger-stick testing. The product labeling states that users should never decide to use insulin based on a GlucoWatch measurement and that users should double-check the GlucoWatch reading with a finger-stick measurement before changing insulin dosages. In addition, the user must calibrate the GlucoWatch with a finger-stick reading each time the device is worn.

A structured evidence review conducted by the BlueCross BlueShield Association Technology Evaluation Center (TEC) (2002) concluded that the GlucoWatch Biographer does not meet the TEC criteria because the impact of this device on health outcomes is unknown.

A technology assessment conducted by CTAF concluded that the GlucoWatch Biographer does not meet CTAF's criteria (Tice, 2003). Furthermore, in a multi-center, randomized controlled study (n = 200), Chase, et al. (2005) concluded that use of the GlucoWatch G2 Biographer in addition to standard glucose monitoring did not improve glycemic control or reduce the frequency of severe hypoglycemia in children with type 1 diabetes.

Alternate Site Blood Glucose Monitors

Blood glucose monitors that permit "alternate site" testing allow persons to test blood samples obtained from sites other than their fingertips, such as the arm or thigh. The primary advantage of alternate site testing is that it may be less painful as there are fewer nerve endings at alternate sites than at the fingertips. However, people who draw blood frequently develop calluses which reduce the pain from finger-stick blood draws.

A Consumer Reports test of several alternate site meters concluded that alternate site testing is "slightly less painful" than fingertip testing. However, thigh samples were found to be "less convenient" than fingertip testing, and forearm samples were "harder to obtain and messier than finger pricks."

Although an alternative blood glucose monitor may be an appropriate choice for persons who can't use a conventional blood glucose monitor, there are a number of concerns about alternate site blood glucose monitors that argue against their routine prescription to all persons with diabetes. First, it is more difficult to start the bleeding at alternate sites, and it is more difficult to stop the bleeding once started. Blood draws from alternate sites may also induce bruising. Second, there is some concern about drawing blood from alternate sites because of diabetic persons' increased risk of infection. Risk of infection may be increased with alternate site testing because there is less blood flow at alternate sites than at fingertips.

A third concern is that alternate site testing may not reflect systemic glucose levels as accurately as finger-sticks, especially when blood glucose levels are rapidly changing, such as after a meal or exercise. This is because blood flow to alternate sites is slower than to the fingertips. Finally, there are no studies proving that alternate site testing improves compliance with blood glucose monitoring.

Home Glycated Hemoglobin Monitors

Aetna considers home glycated hemoglobin (HbA1c or A1C) monitors (e.g., A1cNow Diabetes Monitor, Metrika Inc., Sunnyvale, CA) experimental and investigational. There are no prospective clinical studies demonstrating improvements in compliance or other clinically significant benefits of home A1C testing over laboratory A1C testing. Because A1C testing reflects a mean glycemia over 2-3 months, the American Diabetes Association recommends repeat A1C testing no more frequently than quarterly. Thus, A1C testing can be performed during regularly scheduled office visits. In addition, with office-based testing, health care providers are available to properly interpret the test and to determine whether the person's treatment regimen needs to be modified. An assessment of home glycated hemoglobin monitors by the California Technology Assessment Forum found that there is a paucity of data on home monitoring of HbA1c (Tice, 2003). One study (Rector, et al. 2001) mailed free HbA1c kits to patients with diabetes reported that less than half of the patients used the kits. The main reasons given for not performing the tests were that their physicians had already done the test or that they were too busy. The CTAF assessment (Tice, 2003) noted that "[d]ay to day clinical decisions about diabetes therapy are based on daily glucose testing, not HbA1c. HbA1c levels are usually used to make long-term changes in care in consultation between the patient and their doctor. It is unlikely that home HbA1c testing will improve clinical outcomes for patients with diabetes."

Personal Digital Assistant-Based Blood Glucose Monitors

Aetna considers a personal-digital assistant-based blood glucose monitoring devices (e.g., TheraSense FreeStyle Tracker, Accu-Check Advantage Module) and module not medically necessary because they have not been shown in published clinical studies to improve clinical outcomes over standard blood glucose monitors. (Note: A personal digital assistant (PDA) does not meet Aetna's definition of covered durable medical equipment in that the PDA can be used in the absence of illness or injury.)

The FreeStyle TrackerTM (TheraSense, Inc., Alameda, CA) and the Accu-Check Advantage Module (Roche Diagnostics Corp., Indianapolis, IN) combine a glucose meter with a personal digital assistant (PDA). Together, these create a glucose meter that also tracks and helps manage blood sugar (glucose) levels. Both the FreeStyle Tracker and the Accu-Check Advantage Module use a Handspring VisorTM  PDA, which may be purchased separately. When a glucose module is inserted into its expansion slot, the PDA gives instructions for testing blood sugar and displays the results on its screen. The FreeStyle Tracker Diabetes Management System and the Accu-Check Advantage Module were cleared by the FDA through 510(k) applications in June 2002.

To use these systems, an individual inserts a test strip into the glucose module, pierces the skin with a lancet, and places a drop of blood on the test strip. In addition to showing current blood sugar levels, these systems store readings in an electronic database. This database can also include insulin usage, food intake, exercise, and medicine. These data can be graphed and displayed on the PDA, or they can be uploaded to a personal computer (PC). Note: A personal digital assistant does not meet Aetna's contractual definition of covered DME because a PDA can be of use in the absence of an illness or injury.

In addition, there is an unanswered question about whether these computerized tracking programs improve clinical outcomes. American Diabetes Association guidelines (2003) conclude: "Although a number of SMBG [self-monitoring of blood glucose] methods store test results and with a computer interface can provide sophisticated analyses of blood glucose data, it is not known whether use of these data management systems yields better glucose control than patient review of results recorded in a logbook."

There is no published clinical literature demonstrating that proves that the use of PDA-based blood glucose monitors improves clinical outcomes over standard blood glucose monitors.

Disposable Blood Glucose Monitors

Aetna considers a disposable blood glucose monitor (e.g., the ReliOn NewTek (Hypoguard USA, Inc., Edina, MN)) an acceptable medically necessary alternative to a standard blood glucose monitor. The ReliOn NewTek has been cleared by the FDA for marketing under the 510(k) process for persons with diabetes when recommended by their physician. It includes a disposable meter containing 100 test strips plus control solution. The ReliOn NewTek (Express Blood Glucose Monitoring System) received FDA 510(k) marketing clearance in 2003. According to the FDA 510(k) summary letter submitted by the manufacturer to the FDA, testing demonstrated that its performance was substantially equivalent to the Hypoguard Advance Blood Glucose Monitoring System.