Servicemembers With Uncontrolled Diabetes Allowed to Remain In Military

by | Jun 16, 2020

Continuous Glucose Monitoring

Recognizing that active duty servicemembers, as well as their families and retirees, have diabetes, TRICARE began providing continuous glucose monitoring for members with uncontrolled Type 2 diabetes at the beginning of this year.

Previously, the devices were authorized only in limited circumstances for those with Type 1 diabetes.

Allowed are continuous glucose monitoring system devices approved by the Food and Drug Administration as long as a physician documents:

  • Poor diabetic control after six months of multiple daily insulin injections or insulin pump therapy,

  • Blood glucose self-testing at least four times a day,

  • Completion of a diabetic education program.

Patients are required to have HBA1c greater than 7.0% or less than 4.0%, as well as a history of unexplained large fluctuations in daily glucose values before meals, history of early morning fasting hyperglycemia, or “dawn phenomenon,” and/or history of severe glycemic excursions.

The devices are intended for TRICARE beneficiaries with hypoglycemic unawareness; history of recurrent, unexplained, severe hypoglycemic events (i.e., blood glucose less than 50 mg/dl), history of recurrent episodes of ketoacidosis, hospitalizations for uncontrolled glucose levels and frequent nocturnal hypoglycemia.

With proper documentation, the devices can be used in pregnant women with poorly controlled diabetes or gestational diabetes, according to the health system.

The previous TRICARE criteria for CGMs was much more restrictive, generally limiting their use to Type 1 diabetics who demonstrate significant difficulty regulating their glucose levels and demonstrate severe consequences for out-of-range blood glucose levels. First established in 2008, when the devices were bulky and not particularly reliable, the policy had no significant updates for more than a decade.

According to the policy, only Type 1 diabetics were allowed to use a CGM for up to 72 hours on an intermittent basis, not more than six times per year, if their physician documented:

  • Glycosylated hemoglobin level (HBA1c) is greater than 9.0% or less than 4.0%;

  • History of unexplained large fluctuations in daily glucose values before meals (greater than 150 mg/dl);

  • History of early morning fasting hyperglycemia (“dawn phenomenon”);

  • History of severe glycemic excursions; or

  • Hypoglycemic unawareness.

Use of a CGM for more than 72 hours or on a continuous or periodic basis may be covered for patients who meet the above criteria and have documentation showing:

  • A history of recurrent, unexplained, severe hypoglycemic events or hypoglycemic unawareness (i.e., blood glucose less than 50 mg/dl);

  • A history of recurrent episodes of ketoacidosis;

  • Hospitalizations for uncontrolled glucose levels; or

  • Frequent nocturnal hypoglycemia.

A real-world study presented at the American Diabetes Association 78th Scientific Sessions in 2018 summer found that individuals with Type 1 diabetes who used CGMs had better glycemic control, spent longer time in range and had lower risk for hypoglycemia than those who used a traditional glucometer. Patients using a CGM had a mean HbA1c of 7.5% compared to 8.5% for the glucometer users. Two-thirds of those using the traditional finger stick method of monitoring experienced one or more clinically significant episode of hypoglycemia, nearly twice the rate seen in those using a CGM.2

Patients with Type 2 diabetes achieved similar benefits. A study in 139 patients with Type 2 diabetes on intensive insulin therapy determined that use of factory-calibrated, flash CGM reduced the time patients were in hypoglycemia by 50% over 12 months, even as backup self-monitored blood glucose testing declined from nearly four times a day to 0.2 times per day.3

The greater accuracy of the latest generation of CGMs has reduced or eliminated the need for verification of results with glucometer readings or frequent calibration by patients. As a result, the FDA has approved several devices that eliminate the need for finger sticks entirely.

  1. Folaron I, True MW, Kazanis WH, Wardian JL, et. Al. Diabetes by Air, Land, and Sea: Effect of Deployments on HbA1c and BMI. Military Medicine, Volume 185, Issue 3-4, March-April 2020, Pages 486-92, https://doi.org/10.1093/milmed/usz311.
  2. Munshi M, Toschi E, Slyne C, et al. Use of real time continuous glucose monitoring (CGM) in real life clinical practice compared with finger-stick glucose monitoring. Poster presentation at: ADA 2018 78th Scientific Sessions; June 22-26, 2018; Orlando, FL. Poster 959.
  3. Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Use of flash glucose-sensing technology for 12 months as a replacement for blood glucose monitoring in insulin-treated Type 2 diabetes. Diabetes Ther. 2017;8:573-586.

 

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