BlueCross BlueShield of Tennessee Medical Policy Manual

Artificial Pancreas Device System

DESCRIPTION

Artificial pancreas device systems link a glucose monitor to an insulin infusion pump to automatically reduce and increase subcutaneous insulin delivery according to measured subcutaneous glucose levels using a control algorithm. These devices are intended to reduce hypoglycemic excursions by automatically suspending insulin administration for up to two hours when an individual’s glucose level drops below a preset level, if the individual does not respond to the threshold-suspend alarm.

In 2013, the MiniMed 530G System (Medtronic) became the first artificial pancreas device system to receive FDA approval. This system consists of the following devices that can be used in combination or individually: MiniMed 530G Insulin Pump, EnliteSensor, EnliteSerter, the MiniLink Real-Time System, the Bayer Contour NextLink Glucose Meter, CareLink®Pro Therapy Management Software for Diabetes, and CareLink® Personal Therapy Management Software for Diabetes.

In 2016, the MiniMed 630G system with SmartGuard(Medtronic) received FDA approval. This system is similar to the 530G but offers updates to the system components including waterproofing.

In 2016, the MiniMed 670G System (Medtronic), a hybrid-closed loop insulin delivery system, received FDA approval. This device is the first fully automated artificial pancreas device system. It consists of an insulin pump, a glucose meter, and a transmitter, linked by a proprietary algorithm, and the SmartGuard Hybrid Closed Loop. The system can be programmed to suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values and automatically adjust delivery of basal insulin based on continuous glucose monitor sensor glucose values.

Note: This policy does not address the hybrid closed-loop artificial pancreas system with combined insulin delivery pump and low glucose suspend feature (i.e. Medtronic MiniMed 670G).

POLICY

See also: Diabetes Management

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

SOURCES

American Diabetes Association. (2017). Standards of Medical Care in Diabetes – 2017. Diabetes Care, Vol. 40, Supplement 1.  Retrieved December 4, 2017 from www.diabetes.org.

Bergenstal, R., Klonoff, D., Garg, S., Bode, B., Meredith, M., Slover, R., et. al., (2013). Threshold-Based Insulin-Pump Interruption for Reduction of Hypoglycemia. The New England Journal of Medicine. 369, 224-232. (Level 2 Evidence)

Blue Cross Blue Shield Association. Medical Policy Reference Manual. (11:2017) Artificial pancreas device systems (1.01.30). Retrieved November 27, 2017 from BlueWeb. (14 articles and/or guidelines reviewed)

ECRI Institute. Emerging Technology Report. (February 2015).Threshold-suspend/low-glucose-suspend Insulin delivery systems for managing hypoglycemia in patients with type 1 diabetes mellitus. Retrieved April 2, 2015 from ECRI Institute. (119 articles and/or guidelines reviewed)

Gόmez, A.M., Marn Carrillo,L.F., Muñoz Velandia, O.M., Rondόn Sepúlveda, M.A., Arévalo Correa, C.M., Mora Garzόn, E., et al. (2017). Long-term efficacy and safety of sensor augmented insulin pump therapy with low-glucose suspend feature in patients with type 1 diabetes. Diabetes Technology & Therapeutics, 19 (2), 109-114. Abstract retrieved December 4, 2017 from PubMed database.

Kovatchev, B., Renard, E., Cobelli, C., Zisser, H., Keith-Hynes, P., Anderson, S., et al. (2014) Safety of Outpatient Closed-Loop Control: First Randomized Crossover Trials of a Wearable Artificial Pancreas. Diabetes Care, 37, 1789-1796. (Level 3 evidence)

Ly, T.T., Nicholas, J.A., Retterath, A., Lim, E.M., Davis, E.A., & Jones, T.W. (2013). Effect of sensor-augmented insulin pump therapy and automated insulin suspension vs standard insulin pump therapy on hypoglycemia in patients with type 1 diabetes: a randomized clinical trial. Journal of the American Medical Association, 310 (12), 1240-1247. Abstract retrieved December 4, 2017 from PubMed database.

Perkins, B., Halpern, E., Orszag, A., Weisman, A., Houlden, R., Bergenstal R., et al. (2015) Sensor augmented pump and multiple daily injection therapy in the United States and Canada: post-hoc analysis of a randomized control trial. Canadian Journal of Diabetes, 39 (1), 50-54. Abstract retrieved March 6, 2017 from PubMed database.

Technology Evaluation Center. (April 2014). Artificial pancreas device systems. (Vol. 28, No. 14). Retrieved March 5, 2015 from http://www.bcbs.com.

U. S. Food and Drug Administration. (September 2013). Center for Devices and Radiological Health. Premarket Approval Database P120010 (Minimed® 530G System). Retrieved March 5, 2015 from http://www.accessdata.fda.gov.

ORIGINAL EFFECTIVE DATE:  9/13/2015

MOST RECENT REVIEW DATE:  1/25/2018

ID_BT

Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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