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, Enlite™ Sensor, Enlite™ Serter, 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).
An artificial pancreas system (e.g., MiniMed 630G) may be considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below)
Any device utilized for this purpose must have FDA approval specific to the indication, otherwise it will be considered investigational.
An artificial pancreas system may be considered medically appropriate when ALL of the following are met:
Low glucose suspend feature (e.g., MiniMed 630G)
Type I diabetes mellitus
Age 16 and older
At least six (6) months documentation of self-tested blood glucose levels at least four (4) times per day, including at bedtime
Documentation of two (2) hypoglycemic events (blood glucose less than 70 mg/dl) within a two (2) week period.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
American Diabetes Association. (2018). Standards of Medical Care in Diabetes – 2018. Diabetes Care, Retrieved October 29, 2018 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. Evidence Positioning System. (11:2017) Artificial pancreas device systems (1.01.30). Retrieved October 29, 2018 from http://www.evidencepositioningsystem.com. (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., Marίn 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.
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: 1/10/2019
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