Coverage Guidelines. Continuous Glucose Monitors (CGMs)

Transcription

1 Coverage Guidelines Continuous Glucose Monitors (CGMs) Disclaimer: Please note that Baptist Health Plan Coverage Guidelines may be updated throughout the year. A printed version may not be most up to date version available. The health plan reserves the right to review and update this policy as needed. Refer to the website to ascertain that you are utilizing the most current available version. Clinical guideline policies are not intended to serve as treatment guidelines or treatment recommendation. Treating providers must use their own clinical judgment in rendering care to their patient population. DEFINITION Continuous glucose monitoring (CGM) describes devices that measure glycemic levels over a several day period as a means of detecting diurnal patterns in glucose levels for patients with diabetes mellitus (DM). CMG systems offer 24-hour monitoring that has the capacity to measure long term fluctuations in blood glucose levels. The purpose of CMG is use as adjunct monitoring along with the finger stick as a means of providing a wider range of information to assist in decision support for determining or adjusting glycemic control for patients with diabetes mellitus (DM). CMG systems extract glucose levels from interstitial fluid rather than from blood, and convert results into equivalent blood glucose readings. The purpose of a CMG is for temporary monitoring, and does not represent a replacement for regular finger stick monitoring. 1 The following represents a list of currently available CGM systems: MiniMed Continuous Glucose Monitoring System (CGMS) (Medtronic MiniMed Inc.), ipro2 Continuous Glucose Monitor (Medtronic MiniMed Inc.) DexCom G4 Platinum (DexCom Inc.), DexCom Seven Plus System (DexCom Inc.), FreeStyle Navigator Continuous Glucose Monitoring System (Abbott Diabetes Care), Guardian Real-Time Continuous System (Medtronic MiniMed Inc.). 2 CGM models range in invasiveness from implanted to external. Please note that not all FDA approved models are currently available for use in the United States. 3 Page 1 of 16

2 At the time diabetes is diagnosed the body is producing only 20 to 50% of the insulin it requires. In Type 2 diabetes the elevated blood glucose levels are a result of insulin resistance and insulin deficiency. Insulin resistance is the result of the body not properly using the insulin being produced. Insulin deficiency is when the body is not producing enough insulin. 4 COVERAGE CRITERIA ALL REQUIRED DOCUMENTATION MUST INCLUDE AT LEAST A CONTIGUOUS 30-DAY BLOOD GLUCOSE LOG Continuous glucose monitoring (CGM) for short-term use, as defined by up to 72 hours, is as an adjunct monitoring tool to be used with self-monitoring glucose testing for members meeting all of the following criteria: A diagnosis of type I Diabetes Mellitus (DM) (T1DM), and Member has a history of medical compliance and self-management including but not limited to frequent daily self-monitoring glucose testing, daily insulin injections or the use of an insulin pump, and CGM monitoring data is in order to more appropriately select treatment courses and regimens when target treatment outcomes are not being reached. Measurable disease outcomes include the failure to reach target hemoglobin A1c values, generally less than 7.0%, recurrent episodes of hypoglycemia, hypoglycemic unawareness, or any other disease outcome to be a complication of DM 5 The following CGM systems are designed for short-term use: MiniMed Continuous Glucose Monitoring System (CGMS) and ipro2 Continuous Glucose Monitor CGM for long-term use as defined by more than 72 hours, may be as an adjunct monitoring tool to be used with finger stick glucose testing for adult members meeting all of the following criteria: A diagnosis of T1DM, and Member has a history of medical compliance and self-management including but not limited to self-monitoring glucose testing at a minimum of four finger-sticks per day, daily insulin injections or the use of an insulin pump, and Member has had recurrent and severe hypoglycemia, as defined by blood glucose < 50mg/dL, which is dangerous due to increased risk of severe injury, and 6 7 CGM monitoring data is in order to more appropriately select treatment courses and regimens when target treatment outcomes are not being reached. Measurable disease outcomes include the failure to reach target hemoglobin A1c values, generally less than 7.0%, recurrent episodes of hypoglycemia, hypoglycemic unawareness, or any other disease outcome to be a complication of DM Page 2 of 16

3 The following CGM systems are appropriate and are designed for longer term use: MiniMed Guardian REAL-Time CGMS, DexCom G4 Platinum and DexCom SEVEN systems, and the FreeStyle Navigator. Documentation including HbA1C levels, insulin regimen, and the past two months of blood sugar logs will be reviewed by the Plan to assess medical necessity of CGM use. Continuous glucose monitors are not currently or are experimental / investigational for members with type II DM (T2DM) because they have not been proven efficacious for that diagnosis. 11 MEDICAL BACKGROUND Diabetes mellitus (DM) is a progressive metabolic disease affecting an estimated 16 million and represents the fourth leading cause of death in the US. DM is characterized by the body s failure to adequately produce insulin, which is involved in the synthesis of proteins, fats and carbohydrates. Type I DM (T1DM), otherwise known as juvenile diabetes, is an autoimmune disorder with an average onset of 12 years of age. T1DM is the result of the body s selfdestruction of insulin producing beta cells in the pancreas; therefore, proper treatment for T1DM involves the replacement of insulin with therapy and dosage tailored to the needs of the patient. Type II DM (T2DM) is characterized by inadequate insulin production attributable to a number of causes, including but not limited to beta cell injury secondary to infection, insulin-receptor site shortage, inefficient use due to obesity, or endocrine system disorders. Although T2DM is generally associated with older populations, the recent obesity epidemic has resulted in the onset of T2DM in young adults as well as children to become increasingly common. A number of therapies and disease management tools are available for diabetes management. The most common of which is the self-monitoring of blood glucose, otherwise known as the finger stick. For most patients, the finger stick is the most important and effective tool in daily monitoring real-time glucose levels, which is essential in determining therapy, timing and dosage tailored to the instant results. In addition to therapy, users of self-monitoring blood glucose can also respond to blood glucose test results with an immediate modification in diet and exercise, which can also improve disease outcomes tremendously. 12 In addition to self-monitoring, the clinical marker of hemoglobin A1C (HbA1c) is another disease management tool that exists as an aggregate of glucose levels over time. HbA1C is measured as part of routine laboratory testing and is the gold standard in diabetes control. Long-term HbA1C testing can identify patients with poor glycemic control and facilitate their improvement through changes in therapy. 13 Both self-monitoring and HbA1C have been highly validated, and the relationship between the two has also been well documented. In a study of 27,000 patients with T1DM, a measurable relationship was found between the frequency of use of finger stick glucose monitoring and lower HbA1C values of around 0.2% per additional test per day. 14 Although this large study was made up of children and adolescents, this relationship is well described in adult populations as well. For example, a randomized study comparing CGM to blood glucose monitoring noted the frequency of use as the strongest predictor of lower HbA1C values. 15 For some patients, proper self-management as well as modifications to diet and physical activity may not be enough to improve disease measures. In these cases, the patient may experience such strong fluctuations in blood glucose levels that frequent monitoring as well as HbA1c fails Page 3 of 16

4 to measure the scope and translate into clinical usefulness. In these cases, patients who are engaged in self-management of their disease and are willing to comply with the care being delivered by their provider may still be susceptible to the bad outcomes associated with DM. For some of these patients, continuous glucose monitoring (CGM) may be appropriate as a means of measuring glucose over an extended period. CGM may provide assistance in modifying therapy in order to improve short and long term outcomes. 16 Currently available CGMs measure blood glucose levels through both invasive and noninvasive means. Minimally invasive CGMs involve the implantation of a sensor inserted just beneath the skin of the abdomen that measures the glucose level of interstitial fluid (ISF), while non-invasive models operate by applying electromagnetic radiation through the skin to the blood vessels. CGMs were developed to provide real-time information on the magnitude, duration, frequency and cause of fluctuations in the blood sugar levels of patients with difficult-to-control diabetes. Data printouts of the results of continuous monitoring will provide the patient and physician with decision support data that may be useful for selecting effective therapy. The most important use of continuous blood glucose monitoring is to facilitate adjustments in therapy to improve control. 17 A 2015 updated Hayes, Inc. medical technology report evaluated the use of CGM in several populations. Although this report noted that proven patient selection criteria had not been established, Hayes concluded that sufficient evidence exists to support the use of CGM in adult patients with T1DM who have not achieved adequate glycemic control despite frequent selfmonitoring blood glucose levels. 18 Subsequent evidence has opened the use of CGM to other populations, but the overall proven benefit of CGM remains restricted to patients with T1DM whose current therapy is not preventing DM related complications. The American Diabetes Association (ADA) released the updated Standards in Medical Care of Diabetes. In addition to restating that CGM used in conjunction with intensive insulin regimens can be a useful tool to lower HbA1C levels in selected adults (aged 25 years) with DMT1, the ADA also recommended its use in children, teens and younger adults. Even though the evidence available is not as strong for HbA1C lowering in children, teens, and younger adults, the ADA states that CGM may be beneficial to those groups. The ADA suggests that CGM could also be a supplemental tool to self-monitoring in patients who are unaware of their hypoglycemia or those who have frequent episodes of hypoglycemia. The major policy change in the 2016 update is the committee emphasized that older populations, particularly those over the age of 65 who have benefitted from CGM should continue its use. 19 The Endocrine Society released similar guidelines in 2011 as a result of a comprehensive evidence based assessment of peer-reviewed literature. Children and adolescents with T1DM were recommended in patient selection guidelines as well as adults as a disease management tool for achieving and maintaining favorable disease outcomes such as an HbA1c of less than 7%. 20 The first randomized, controlled, multicenter trial of continuous glucose monitoring using the STS System made by DexCom included 91 insulin dependent diabetics. DexCom provided the devices used for the study and they provide research support to Satish Garg, M.D., one of the authors of the study. Forty-four of the participants were assigned to a control group who received no continuous glucose data, and 47 were assigned to the display group who had access to the data provided by the continuous glucose monitoring for the last two-thirds of the study. Results showed the display group spent 21% less time as hypoglycemic, 23% less time as hyperglycemic, and 26% more time in the target ( mg/dl) glucose range demonstrating Page 4 of 16

5 access to data from a continuous glucose monitor may significantly improve glycemic fluctuations which may reduce long-term complications of diabetes. 21 A small study of 86 insulin-dependent diabetics participated in a study to evaluate the safety and value of transcutaneous, real-time, CGM. The subjects wore sensors inserted under the skin of the abdomen for 21 consecutive days (three periods of seven days each). Each subject inserted the sensor under clinical staff supervision using an introducer needle and applicator. Two of the three periods were conducted with the participants un-blinded to the CGM results. During those two periods the CGM data and finger-stick-only self-monitoring of blood glucose (SMBG) were used. The subjects returned to the clinic on the 8 th and 15 th days of the study for sensor replacement and on the 22 nd day for sensor removal. The authors not only concluded that the seven-day CGM was safe and well-tolerated, it may help patients with poor glycemic control achieve lower A1C levels by providing real-time fasting and evening hyperglycemia and the period of dawn phenomenon blood glucose levels. This article was classified as an advertisement because costs of publication were defrayed in part by the payment of page charges. Both authors received research funding to their respective institutes from DexCom, a manufacturer of one brand of CGM. The authors are on the DexCom advisory board and have received fees from DexCom for various educational activities. 22 The first seven-day continuous glucose monitoring system was approved by the FDA on June 7, Approval was based on results of a clinical trial conducted by the manufacturer, DexCom, on just 72 patients. This leaves the STS-7 System in the very earliest stages of study. More and larger randomized clinical trials are necessary to determine the safety and efficacy of the STS-7 System before there is enough information to make an informed decision for or against its use. 23 A randomized clinical trial of 322 adults with T1DM was assigned to monitor levels using CGM or blood glucose. Following the end of the 26-week study period, the group using CGM achieved a reduction in HbA1C values of 0.5%. No such reduction was noted in the selfmonitoring group. 24 In a meta-analysis analyzing nearly 900 patients from six studies, the impact of HbA1C was found to be 0.3% lower in the CGM group. There was also a notable difference found in hypoglycemia in this same group, although the authors question the statistical significance of this finding given the heterogeneity of studies. 25 These results are likewise evident in a number of meta-analyses. The overall benefit of CGM systems lies in the monitoring of values over time as a means of capturing fluctuations not easily identified from glucose monitoring alone. However, the internal validity of CGM in measuring interstitial glucose concentrations and converting these values to equivalent blood glucose levels accurately remains inferior to glucose monitors. The accuracy of CGM is well explored in the literature, with varying reports of inconsistencies relative to glucose ranges and CGM models. In a recent study of 60,000 paired readings obtained from 72 patients comparing CGM and blood glucose results, only 75% of readings from CGM matched blood glucose values within plus or minus 20 points, and 87% were within plus or minus 30 points. 30 The range at which values tended to agree most frequently was between 240 and 400 mg/dl. 31 This finding is consistent with other reports demonstrating that CGM tends to be less accurate for reading lower glucose levels, particularly those of less than 80 mg/dl. One study found the variability rate for this range at 21.5%. 32 Given this evidence, CGM is not recommended for use without corresponding blood glucose. According to Hayes, the few studies of CGM in Type 2 DM yielded promising results, but not enough data had been established to make an absolute determination. A 2011 meta-analysis found consistent results. Of the 19 studies included in this analysis, only three included patients Page 5 of 16

6 with Type 2 DM. Although Gandhi, et al., found a significant impact on the use of CGM on the lowering effect of HbA1C in both Type 1 DM and Type 2 DM, there were too few patients in the latter arm to make a case for a clinical role of CMG in Type 2 DM. However, the role CGM was consistent in this meta-analysis with previous studies. 33 More research needs to be published in order to determine the clinical utility of CGM in Type 2 DM. REGULATORY INFORMATION Continuous glucose monitors and combination continuous glucose monitors/insulin pump devices require U.S. FDA CDHR approval. Kentucky No legislative mandates were found for coverage of continuous glucose monitors. 34 Indiana No legislative mandates were found for coverage of continuous glucose monitors. 35 Tennessee No legislative mandates were found for coverage of continuous glucose monitors. 36 Baptist Health Plan Coverage Guidelines are created to provide members and providers with peer-reviewed, current medical information. State and federal laws/mandates and contract language have priority over Coverage Guidelines and must be taken into consideration before eligibility for coverage is determined. Baptist Health Plan Coverage Guidelines may or may not mirror Centers for Medicare & Medicaid Services benefits or coverage offered by any other health insurance company. For self-funded plans, consult individual plan documents. If there is a conflict between this policy and a self-funded plan document, the provisions of the plan document will govern. In addition, coverage for Medicare Advantage members may differ. This is a result of applicable coverage statements by the Center for Medicare and Medicaid Services (CMS). The National Coverage Determinations, Local Coverage Determinations, and Local Medical Review Policies may be found at the CMS website, Please note that for all plans, the member s health plan benefits that are in effect on the rendered date of service must be used in coverage determinations COVERAGE DETAIL CODES INCLUDE BUT MAY NOT BE LIMITED TO THE FOLLOWING: Page 6 of 16

7 CPT Codes Description Coverage Information Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 hours; physician interpretation and report HCPC Codes A4222 A4230 Description Infusion supplies for external drug infusion pump, per cassette or bag (list drugs separately) Infusion set for external insulin pump, non-needle cannula type Coverage Information A4231 Infusion set for external insulin pump, needle type A4232 Syringe with needle for external insulin pump, sterile, 3 cc A4602 A9274 A9276 A9277 A9278 A9279 Replacement battery for external infusion pump owned by patient, lithium, 1.5 volt, each See the Certificate of Coverage and the Durable Medical Equipment Coverage Guideline for additional criteria. External ambulatory insulin delivery system, disposable, each, includes all supplies and accessories Sensor, invasive (e.g., subcutaneous), disposable, for use with interstitial continuous glucose monitoring system, one unit = 1-day supply Transmitter; external, for use with interstitial continuous glucose monitoring system Receiver (monitor); external, for use with interstitial continuous glucose monitoring system Monitoring feature/device, stand-alone or integrated, any type, includes all accessories, components and electronics, not otherwise classified or is E0784 External ambulatory infusion pump, insulin Page 7 of 16

8 K0552 K0601 Supplies for external drug infusion pump, syringe type cartridge, sterile, each Replacement battery for external infusion pump owned by patient, silver oxide, 1.5 volt, each See the Certificate of Coverage and the Durable Medical Equipment Coverage Guideline for additional criteria. or is J1815 Injection, insulin, per 5 units J1817 ICD.9 Diagnosis Codes Insulin for administration through DME (i.e., insulin pump) per 50 units Description Coverage Information Diabetes mellitus; Diabetes mellitus without mention of complication; Diabetes mellitus without mention of complication, type II or unspecified type, not stated as Diabetes mellitus; Diabetes mellitus without mention of complication; Diabetes mellitus without mention of complication, type I [juvenile type], not stated as Diabetes mellitus; Diabetes mellitus without mention of complication; Diabetes mellitus without mention of complication, type II or unspecified type, Diabetes mellitus; Diabetes mellitus without mention of complication; Diabetes mellitus without mention of complication, type I [juvenile type], Diabetes mellitus; Diabetes with ketoacidosis; Diabetes with ketoacidosis, type II or unspecified type, not stated as Diabetes mellitus; Diabetes with ketoacidosis; Diabetes with ketoacidosis, type I [juvenile type], not stated as or is or is or is Page 8 of 16

9 Diabetes mellitus; Diabetes with ketoacidosis; Diabetes with ketoacidosis, type II or unspecified type, Diabetes mellitus; Diabetes with ketoacidosis; Diabetes with ketoacidosis, type I [juvenile type], Diabetes mellitus; Diabetes with hyperosmolarity; Diabetes with hyperosmolarity, type II or unspecified type, not stated as Diabetes mellitus; Diabetes with hyperosmolarity; Diabetes with hyperosmolarity, type I [juvenile type], not stated as Diabetes mellitus; Diabetes with hyperosmolarity; Diabetes with hyperosmolarity, type II or unspecified type, Diabetes mellitus; Diabetes with hyperosmolarity; Diabetes with hyperosmolarity, type I [juvenile type], Diabetes mellitus; Diabetes with other coma; Diabetes with other coma, type II or unspecified type, not stated as Diabetes mellitus; Diabetes with other coma; Diabetes with other coma, type I [juvenile type], not stated as Diabetes mellitus; Diabetes with other coma; Diabetes with other coma, type II or unspecified type, Diabetes mellitus; Diabetes with other coma; Diabetes with other coma, type I [juvenile type], or is or is or is or is or is Page 9 of 16

10 Diabetes mellitus; Diabetes with renal manifestations; Diabetes with renal manifestations, type II or unspecified type, not stated as Diabetes mellitus; Diabetes with renal manifestations; Diabetes with renal manifestations, type I [juvenile type], not stated as Diabetes mellitus; Diabetes with renal manifestations; Diabetes with renal manifestations, type II or unspecified type, Diabetes mellitus; Diabetes with renal manifestations; Diabetes with renal manifestations, type I [juvenile type], Diabetes mellitus; Diabetes with ophthalmic manifestations; Diabetes with ophthalmic manifestations, type II or unspecified type, not stated as Diabetes mellitus; Diabetes with ophthalmic manifestations; Diabetes with ophthalmic manifestations, type I [juvenile type], not stated as Diabetes mellitus; Diabetes with ophthalmic manifestations; Diabetes with ophthalmic manifestations, type II or unspecified type, Diabetes mellitus; Diabetes with ophthalmic manifestations; Diabetes with ophthalmic manifestations, type I [juvenile type], Diabetes mellitus; Diabetes with ophthalmic manifestations, type I [juvenile type], ; Diabetes with neurological manifestations, type II or unspecified type, not stated as Diabetes mellitus Diabetes with ophthalmic manifestations, type I [juvenile type], ; or is or is or is or is or is Page 10 of 16

11 Diabetes with neurological manifestations, type I [juvenile type], not stated as Diabetes mellitus; Diabetes with ophthalmic manifestations, type I [juvenile type], ; Diabetes with neurological manifestations, type II or unspecified type, Diabetes mellitus; Diabetes with ophthalmic manifestations, type I [juvenile type], ; Diabetes with neurological manifestations, type II or unspecified type, Diabetes mellitus; Diabetes with peripheral circulatory disorders; Diabetes with peripheral circulatory disorders, type II or unspecified type, not stated as Diabetes mellitus; Diabetes with peripheral circulatory disorders; Diabetes with peripheral circulatory disorders, type I [juvenile type], not stated as Diabetes mellitus; Diabetes with peripheral circulatory disorders; Diabetes with peripheral circulatory disorders, type II or unspecified type, Diabetes mellitus; Diabetes with peripheral circulatory disorders; Diabetes with peripheral circulatory disorders, type I [juvenile type], Diabetes mellitus; Diabetes with other specified manifestations; Diabetes with other specified manifestations, type II or unspecified type, not stated as Diabetes mellitus; Diabetes with other specified manifestations; Diabetes with other specified manifestations, type I [juvenile type], not stated as Diabetes mellitus; Diabetes with other specified manifestations; Diabetes with other specified manifestations, type II or unspecified type, or is May be medically necessary when criteria are met or is May be medically necessary when criteria are met or is May be medically necessary when criteria are met or is Page 11 of 16

12 Diabetes mellitus; Diabetes with other specified manifestations; Diabetes with other specified manifestations, type I [juvenile type], Diabetes mellitus; Diabetes with unspecified complication; Diabetes with unspecified complication, type II or unspecified type, not stated as Diabetes mellitus; Diabetes with unspecified complication; Diabetes with unspecified complication, type I [juvenile type], not stated as Diabetes mellitus; Diabetes with unspecified complication; Diabetes with unspecified complication, type II or unspecified type, Diabetes mellitus; Diabetes with unspecified complication; Diabetes with unspecified complication, type I [juvenile type], Other current conditions in the mother classifiable elsewhere, but complicating pregnancy, childbirth, or the puerperium; Diabetes mellitus; Maternal diabetes mellitus, complicating pregnancy, childbirth, or the puerperium, unspecified as to episode of care Other current conditions in the mother classifiable elsewhere, but complicating pregnancy, childbirth, or the puerperium; Diabetes mellitus; Maternal diabetes mellitus with delivery Other current conditions in the mother classifiable elsewhere, but complicating pregnancy, childbirth, or the puerperium; Diabetes mellitus; Maternal diabetes mellitus with delivery, with current postpartum complication May be medically necessary when criteria are met or is May be medically necessary when criteria are met or is investigational May be medically necessary when criteria are met or is or is or is Other current conditions in the mother classifiable elsewhere, but complicating pregnancy, childbirth, or the puerperium; Diabetes mellitus; Maternal diabetes mellitus, antepartum or is Page 12 of 16

13 Other current conditions in the mother classifiable elsewhere, but complicating pregnancy, childbirth, or the puerperium; Diabetes mellitus; Maternal diabetes mellitus, complicating pregnancy, childbirth, or the puerperium, postpartum condition or complication or is V45.85 Other postprocedural states; Insulin pump status or is V58.67 Encounter for other and unspecified procedures and aftercare; Long-term (current) drug use; Long-term (current) use of insulin or is ICD.10 Diagnosis Codes E E08.9 E E09.9 E E10.9 E E11.9 E E Description Diabetes mellitus due to underlying condition Drug or chemical induced diabetes mellitus Type 1 diabetes mellitus Type 2 diabetes mellitus Other specified diabetes mellitus Diabetes mellitus in pregnancy, childbirth, and the puerperium Coverage Information or is REFERENCES Page 13 of 16

14 1 Hayes, Inc. Hayes Technology Directory. Continuous glucose monitoring systems. August 13, Available to subscribers at: Accessed April 6, United States Food and Drug Administration (FDA) web site. Available at: Accessed February 17, Hayes, Inc. Hayes Technology Directory. Continuous glucose monitoring systems. December 18, Available to subscribers at: Accessed February 16, American Diabetes Association web site. Key Nutrients: American Diabetes Association. Available at: Accessed June 4, Hayes, Inc. Hayes Technology Directory. Continuous glucose monitoring systems. August 13, Available to subscribers at: Accessed April 6, Hayes, Inc. Hayes Technology Directory. Continuous glucose monitoring systems. August 13, Available to subscribers at: Accessed April 6, American Diabetes Associates web site. Standards of medical care in diabetes January Available at: Accessed February 17, American Diabetes Associates web site. Standards of medical care in diabetes January Available at: Accessed February 17, Hayes, Inc. Hayes Technology Directory. Continuous glucose monitoring systems. August 13, Available to subscribers at: Accessed April 6, Klondoff DC, Buckingham B, Christiansen JS, et al. Continuous glucose monitoring: An Endocrine Society. J Clin Endocrinol Metab. 2011;96: Hayes, Inc. Hayes Technology Directory. Continuous glucose monitoring systems. August 13, Available to subscribers at: Accessed April 6, American Diabetes Associates web site. Standards of medical care in diabetes January Available at: Accessed April 1, Delamater AM. Clinical use of hemoglobin A1c to improve diabetes management. Clin Diabetes. 2006;24(1): Cooper MN, O Connell SM, Davis EA, Jones TW. A population-based study of risk factors for severe hypoglycaemia in a contemporary cohort of childhood-onset type 1 diabetes. Diabetologia. 2013;56: Hsu C-W, Sun S-F, Lin S-L, Huang H-H, Wong K-F. Moderate glucose control results in less negative nitrogen balances in medical intensive care unit patients: a randomized, controlled study. Crit Care. 2012;16:R Hayes, Inc. Hayes Technology Directory. Continuous glucose monitoring systems. August 13, Available to subscribers at: Accessed April 6, Klonoff DC. Continuous glucose monitoring: Roadmap for 21 st century diabetes therapy. Diabetes Care. 2005;28: Hayes, Inc. Hayes Technology Directory. Continuous glucose monitoring systems. August 13, Available to subscribers at: Accessed April 6, Page 14 of 16

15 19 American Diabetes Associates web site. Standards of medical care in diabetes January Available at: Accessed April 1, Klondoff DC, Buckingham B, Christiansen JS, et al. Continuous glucose monitoring: An Endocrine Society. J Clin Endocrinol Metab. 2011;96: Garg S, Zisser, Schwartz S, et al. Improvement in glycemic excursions with a transcutaneous, real-time continuous glucose sensor. Diabetes Care. 2006;29(1): Garg S, Jovanovic L. Relationship of fasting and hourly blood glucose levels to HbA1C values. Diabetes Care. 2006;29: United States Food and Drug Administration (FDA) web site. FDA approves continuous 7- day glucose monitoring system. Available at: Accessed February Hsu C-W, Sun S-F, Lin S-L, Huang H-H, Wong K-F. Moderate glucose control results in less negative nitrogen balances in medical intensive care unit patients: a randomized, controlled study. Crit Care. 2012;16:R56 25 Pickup JC, Freeman SC, Sutton AJ. Glycemic control in type 1 diabetes during real time continuous glucose monitoring compared with self-monitoring of blood glucose: meta-analysis of randomized controlled trials using individual patient data. BMJ. 2011;343:d Gandhi GY, Kovalaske M, Kudva Y, et al. Efficacy of continuous glucose monitoring in improving glycemic control and reducing hypoglycemia: a systematic review and meta-analysis of randomized trials. J Diabetes Sci Technol (4): Yeh HC, Brown TT Maruther N, et al. Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and metaanalysis. Ann Intern Med. 2012;157: Langendam M, Luijf YM, Hooft L, et al. Continuous glucose monitoring for type 1 diabetes. Cochrane Database Syst Rev Jan 18;1:CD Szypowska A. Ramotowska A, Dzygalo K, Golicki D. Beneficial effect of real-time continuous glucose monitoring system on glycemic control in type 1 diabetic patients: systematic review and meta-analysis of randomized trials. J Diabetes Sci Technol. 2011;5: Mastrototaro J, Shin J, Marcus A, et al. The accuracy and efficacy of real-time continuous glucose monitoring sensor in patients with type 1 diabetes. Diabetes Technol Ther. 2008;10: Castle JR, Pitts A, Hanavan K, et al. The accuracy benefit of multiple amperometric glucose sensors in people with type 1 diabetes. Diabetes Care. 2012;35: Garg SK, Smith J, Beatson C, et al. Comparison of accuracy and safety of the SEVEN and Navigator continuous glucose sensors in people with type 1 diabetes. Diabetes Care. 2012;35: Gandhi GY, Kovalaske M, Kudva Y, et al. Efficacy of continuous glucose monitoring in improving glycemic control and reducing hypoglycemia: a systematic review and meta-analysis of randomized trials. J Diabetes Sci Technol (4): Kentucky Legislature web site. Coverage for diabetes. Available at: Accessed November 5, Page 15 of 16

16 35 Indiana State Department of Health web site. Coverage for services related to diabetes. Available at: Accessed November 5, Tennessee Legislative Information web site. Available at: Accessed November 5, SEARCH TERMS A1c Blood sugar DexCom Diabetes Diabetes mellitus Endocrine Finger stick Free style Glucose Guardian IPro2 Insulin MiniMed Monitor Type Page 16 of 16