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1.
sarah314
Aetna has already made that information publically available on its website. They are under no obligation to provide you anything further than that.
Here are the studies cited in the website - it took me less than 5 minutes to find the documentation. (Additionally, its unreasonable for you to expect them to provide you with detailed information about other insurance companies.)
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.
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. 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 American Diabetes Association Position Statement “Tests of Glycemia in Diabetes” (2004) recommends that the frequency and timing of glucose monitoring be dictated by the needs and goals of the individual patient. For most persons with type 1 diabetes, self-monitoring of blood glucose three or four times daily by the standard finger-stick method is sufficient. The ADA guidelines conclude that the “role [of CGMS] in improving diabetes outcomes remains to be established.”
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].”
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.
# TheraSense, Inc. FreeStyle Tracker Diabetes Management System. Special 510(k) device modification. 510(k) no. K020866. Rockville, MD: U.S. Food and Drug Administration, Center for Devices and Radiologic Health; June 11, 2002. Available at: http://www.fda.gov/cdrh/pdf2/k020866.pdf... Accessed February 24, 2002.
# Chico A, Vidal-Rios P, Subira M, et al. The continuous glucose monitoring system is useful for detecting unrecognized hypoglycemias in patients with type 1 and type 2 diabetes but is not better than frequent capillary glucose measurements for improving metabolic control. Diabetes Care. 2003;26(4):1153-1157.
# Amin R, Ross K, Acerini CL, et al. Hypoglycemia prevalence in prepubertal children with type 1 diabetes on standard insulin regimen: Use of continuous glucose monitoring system. Diabetes Care. 2003;26(3):662-667.
# Guerci B, Floriot M, Bohme P, et al. Clinical performance of CGMS in type 1 diabetic patients treated by continuous subcutaneous insulin infusion using insulin analogs. Diabetes Care. 2003;26(3):582-589.
# Mastrototaro JJ, Gross TM. Reproducibility of the continuous glucose monitoring system matches previous reports and the intended use of the product. Diabetes Care. 2003;26(1):256.
# Cheyne EH, Cavan DA, Kerr D. Performance of a continuous glucose monitoring system during controlled hypoglycaemia in healthy volunteers. Diabetes Technol Ther. 2002;4(5):607-613.
# Kaufman FR, Austin J, Neinstein A, et al. Nocturnal hypoglycemia detected with the Continuous Glucose Monitoring System in pediatric patients with type 1 diabetes. J Pediatr. 2002;141(5):625-630.
# Choleau C, Dokladal P, Klein JC, et al. Prevention of hypoglycemia using risk assessment with a continuous glucose monitoring system. Diabetes. 2002;51(11):3263-3273.
# Salardi S, Zucchini S, Santoni R, et al. The glucose area under the profiles obtained with continuous glucose monitoring system relationships with HbA(lc) in pediatric type 1 diabetic patients. Diabetes Care. 2002;25(10):1840-1844.
# Sharp P, Rainbow S. Continuous glucose monitoring and haemoglobin A(1c). Ann Clin Biochem. 2002;39(Pt 5):516-517.
# Speiser PW. Continuous glucose monitoring in managing diabetes in children. Diabetes Metab Res Rev. 2002;18(4):330-331.
# Schiaffini R, Ciampalini P, Fierabracci A, et al. The Continuous Glucose Monitoring System (CGMS) in type 1 diabetic children is the way to reduce hypoglycemic risk. Diabetes Metab Res Rev. 2002;18(4):324-329.
# McGowan K, Thomas W, Moran A. Spurious reporting of nocturnal hypoglycemia by CGMS in patients with tightly controlled type 1 diabetes. Diabetes Care. 2002;25(9):1499-1503.
# Heinemann L, Koschinsky T. Continuous glucose monitoring: An overview of today's technologies and their clinical applications. Int J Clin Pract Suppl. 2002;(129):75-79.
# Jamali R, Ludvigsson J, Mohseni S. Continuous monitoring of the subcutaneous glucose level in freely moving normal and diabetic rats and in humans with type 1 diabetes. Diabetes Technol Ther. 2002;4(3):305-312.
# Maran A, Crepaldi C, Tiengo A, et al. Continuous subcutaneous glucose monitoring in diabetic patients: A multicenter analysis. Diabetes Care. 2002;25(2):347-352.
# Kaufman FR, Gibson LC, Halvorson M, et al. A pilot study of the continuous glucose monitoring system: Clinical decisions and glycemic control after its use in pediatric type 1 diabetic subjects. Diabetes Care. 2001;24(12):2030-2034.
# Boland E, Monsod T, Delucia M, et al. Limitations of conventional methods of self-monitoring of blood glucose: Lessons learned from 3 days of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care. 2001;24(11):1858-1862.
# 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.
# Robert JJ. Continuous monitoring of blood glucose. Horm Res. 2002;57 Suppl 1:81-84.
# Potts RO, Tamada JA, Tierney MJ. Glucose monitoring by reverse iontophoresis. Diabetes Metab Res Rev. 2002;18 Suppl 1:S49-S53.
# 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 Bioelectron. 2001;16(9-12):621-629.
# Edelman SV. Watching your glucose with the GlucoWatch. Diabetes Technol Ther. 2001;3(2):283-284.
# No authors listed. Glucowatch Biographer: A noninvasive glucose monitoring device. Med Lett Drugs Ther. 2001;43(1104):42.
# Pitzer KR, Desai S, Dunn T, et al. Detection of hypoglycemia with the GlucoWatch biographer. Diabetes Care. 2001;24(5):881-885.
# Tierney MJ, Tamada JA, Potts RO, et al. The GlucoWatch biographer: A f
Here are the studies cited in the website - it took me less than 5 minutes to find the documentation. (Additionally, its unreasonable for you to expect them to provide you with detailed information about other insurance companies.)
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.
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. 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 American Diabetes Association Position Statement “Tests of Glycemia in Diabetes” (2004) recommends that the frequency and timing of glucose monitoring be dictated by the needs and goals of the individual patient. For most persons with type 1 diabetes, self-monitoring of blood glucose three or four times daily by the standard finger-stick method is sufficient. The ADA guidelines conclude that the “role [of CGMS] in improving diabetes outcomes remains to be established.”
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].”
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.
# TheraSense, Inc. FreeStyle Tracker Diabetes Management System. Special 510(k) device modification. 510(k) no. K020866. Rockville, MD: U.S. Food and Drug Administration, Center for Devices and Radiologic Health; June 11, 2002. Available at: http://www.fda.gov/cdrh/pdf2/k020866.pdf... Accessed February 24, 2002.
# Chico A, Vidal-Rios P, Subira M, et al. The continuous glucose monitoring system is useful for detecting unrecognized hypoglycemias in patients with type 1 and type 2 diabetes but is not better than frequent capillary glucose measurements for improving metabolic control. Diabetes Care. 2003;26(4):1153-1157.
# Amin R, Ross K, Acerini CL, et al. Hypoglycemia prevalence in prepubertal children with type 1 diabetes on standard insulin regimen: Use of continuous glucose monitoring system. Diabetes Care. 2003;26(3):662-667.
# Guerci B, Floriot M, Bohme P, et al. Clinical performance of CGMS in type 1 diabetic patients treated by continuous subcutaneous insulin infusion using insulin analogs. Diabetes Care. 2003;26(3):582-589.
# Mastrototaro JJ, Gross TM. Reproducibility of the continuous glucose monitoring system matches previous reports and the intended use of the product. Diabetes Care. 2003;26(1):256.
# Cheyne EH, Cavan DA, Kerr D. Performance of a continuous glucose monitoring system during controlled hypoglycaemia in healthy volunteers. Diabetes Technol Ther. 2002;4(5):607-613.
# Kaufman FR, Austin J, Neinstein A, et al. Nocturnal hypoglycemia detected with the Continuous Glucose Monitoring System in pediatric patients with type 1 diabetes. J Pediatr. 2002;141(5):625-630.
# Choleau C, Dokladal P, Klein JC, et al. Prevention of hypoglycemia using risk assessment with a continuous glucose monitoring system. Diabetes. 2002;51(11):3263-3273.
# Salardi S, Zucchini S, Santoni R, et al. The glucose area under the profiles obtained with continuous glucose monitoring system relationships with HbA(lc) in pediatric type 1 diabetic patients. Diabetes Care. 2002;25(10):1840-1844.
# Sharp P, Rainbow S. Continuous glucose monitoring and haemoglobin A(1c). Ann Clin Biochem. 2002;39(Pt 5):516-517.
# Speiser PW. Continuous glucose monitoring in managing diabetes in children. Diabetes Metab Res Rev. 2002;18(4):330-331.
# Schiaffini R, Ciampalini P, Fierabracci A, et al. The Continuous Glucose Monitoring System (CGMS) in type 1 diabetic children is the way to reduce hypoglycemic risk. Diabetes Metab Res Rev. 2002;18(4):324-329.
# McGowan K, Thomas W, Moran A. Spurious reporting of nocturnal hypoglycemia by CGMS in patients with tightly controlled type 1 diabetes. Diabetes Care. 2002;25(9):1499-1503.
# Heinemann L, Koschinsky T. Continuous glucose monitoring: An overview of today's technologies and their clinical applications. Int J Clin Pract Suppl. 2002;(129):75-79.
# Jamali R, Ludvigsson J, Mohseni S. Continuous monitoring of the subcutaneous glucose level in freely moving normal and diabetic rats and in humans with type 1 diabetes. Diabetes Technol Ther. 2002;4(3):305-312.
# Maran A, Crepaldi C, Tiengo A, et al. Continuous subcutaneous glucose monitoring in diabetic patients: A multicenter analysis. Diabetes Care. 2002;25(2):347-352.
# Kaufman FR, Gibson LC, Halvorson M, et al. A pilot study of the continuous glucose monitoring system: Clinical decisions and glycemic control after its use in pediatric type 1 diabetic subjects. Diabetes Care. 2001;24(12):2030-2034.
# Boland E, Monsod T, Delucia M, et al. Limitations of conventional methods of self-monitoring of blood glucose: Lessons learned from 3 days of continuous glucose sensing in pediatric patients with type 1 diabetes. Diabetes Care. 2001;24(11):1858-1862.
# 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.
# Robert JJ. Continuous monitoring of blood glucose. Horm Res. 2002;57 Suppl 1:81-84.
# Potts RO, Tamada JA, Tierney MJ. Glucose monitoring by reverse iontophoresis. Diabetes Metab Res Rev. 2002;18 Suppl 1:S49-S53.
# 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 Bioelectron. 2001;16(9-12):621-629.
# Edelman SV. Watching your glucose with the GlucoWatch. Diabetes Technol Ther. 2001;3(2):283-284.
# No authors listed. Glucowatch Biographer: A noninvasive glucose monitoring device. Med Lett Drugs Ther. 2001;43(1104):42.
# Pitzer KR, Desai S, Dunn T, et al. Detection of hypoglycemia with the GlucoWatch biographer. Diabetes Care. 2001;24(5):881-885.
# Tierney MJ, Tamada JA, Potts RO, et al. The GlucoWatch biographer: A f
2.
mbrcatz
It fully depends on WHY they are denying the appeal.
They don't have to give you any of that information.
You need to take the reason why they're denying it, and file a written complaint with your state insurance commissioner, refuting EVERY SINGLE POINT of denial.
They don't have to give you any of that information.
You need to take the reason why they're denying it, and file a written complaint with your state insurance commissioner, refuting EVERY SINGLE POINT of denial.
3.
Custo
If your insurance is self-insurance through your (or a spouses) employer group, ask HR for help. If not, ask the department of insurance in your state.
Its experimental. Sorry.
Its experimental. Sorry.
Doctors in Ada, MN
-
Bridges Medical Center in Ada, MN
201 9th St W, Ada, MN 56510 -
Essentia Health in Ada, MN
201 9th St W, Ada, MN 56510
