UnitedHealthcare's Preferred Insulin Pump Program Drives Safety and Quality

We would like to acknowledge and thank members of the diabetes community for your interest and feedback on our decision to offer the MiniMed™ system from Medtronic as UnitedHealthcare’s preferred insulin pump for adults and children age 7 and older. We based our decision on clinical evidence that continues to demonstrate this is a safe, effective continuous insulin delivery system and helps people with diabetes avoid both highs and lows in their blood sugar level.

Also, we understand the important role pump choice plays in an individual’s overall management of their diabetes and have included provisions we believe take an individual’s unique needs, and the relationship between patients and physicians, into account.  For example, we offer a clinical review process if a prescribing physician feels a non-Medtronic device is preferred based on an individual patient’s clinical circumstances.  Our goal is to make the review process as simple and efficient as possible for both the prescribing physician and the patient.

It’s also important to note that children currently using a non-Medtronic pump may remain on that pump as long as they wish.

Finally, our agreement with Medtronic doesn’t prevent our members from accessing new, innovative technology brought to market.  We will review any published, peer-reviewed clinical evidence that supports our members’ access to new, advanced therapies to help manage their diabetes and evaluate the availability of coverage under the member’s benefit plan.

We value ongoing collaboration and open dialogue with the diabetes community to advance new ideas and approaches to safe, effective therapies that help people with diabetes stay healthy and live full and active lives.

Questions and Answers

UnitedHealthcare decided to expand its current preferred insulin pump agreement following the FDA’s expanded approval of the MiniMed 670G insulin pump system to include children ages 7 and up. This decision is supported by the comprehensive and rigorous body of clinical trial and real-world data strongly supports the safety and efficacy of the MiniMed 670G system. Clinical trial results show the percentage of Time in Range for patients increased from 56.2 percent to 65.0 percent. A1C levels were also reduced from 7.9 percent to 7.5 percent. Only 3.8 percent of time was spent below (low) healthy Time in Range versus 6 percent compared to baseline.1

Yes. FDA approval was based on positive results from a pediatric clinical trial, which demonstrated the safety of the MiniMed 670G system in this younger patient population.2 Data was analyzed from 105 children between seven and 13 years of age with type 1 diabetes during a two-week baseline period in open-loop mode (traditional pump therapy), followed by a three-month in-home study period with the hybrid-closed loop (SmartGuard Auto Mode) enabled. The results showed the percentage of Time in Range increased from 56.2 percent to 65.0 percent. A1C levels were also reduced from 7.9 percent to 7.5 percent. There were no incidences of diabetic ketoacidosis (DKA) in the study phase in Auto Mode and no severe hypoglycemic or serious device-related adverse events were reported. Almost all children continued to use the pump after the study concluded.

Pediatric patients who are currently using a non-Medtronic pump may remain on that pump in conjunction with the physician’s treatment plan. There is no immediate change to coverage for members currently on an insulin pump and receiving supplies.                        

For members receiving a prescription for an insulin pump for the first time, the MiniMed™ system from Medtronic is our preferred pump for adults and children age 7 and older, given the safety and quality it offers.

We will continue to have a clinical review process in place for prescribing physicians and members who feel a non-Medtronic device may be preferred.  If a patient and his/her doctor feel there is a medical need to use a non-Medtronic pump, we will work directly with the prescribing physician on the request. If approved, an alternate pump would be covered at the in-network benefit level through a participating provider.

The effective date is February 1, 2019

*The Medtronic MiniMed™ 670G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons, age 7 and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed™ 670G system includes SmartGuard™ technology, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values. The system requires a prescription. The Guardian™ Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. A confirmatory finger stick test via the CONTOURRNEXT LINK 2.4 blood glucose meter is required prior to making adjustments to diabetes therapy. All therapy adjustments should be based on measurements obtained using the CONTOURRNEXT LINK 2.4 blood glucose meter and not on values provided by the Guardian™ Sensor (3). Always check the pump display to help ensure the glucose result shown agrees with the glucose results shown on the CONTOURRNEXT LINK 2.4 blood glucose meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an Alternative Site (palm) or from a control solution test. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise. If a control solution test is out of range, please note that the result may be transmitted to your pump when in the “Always” send mode.

1 Bergenstal RM, Garg S, Weinzimer SA, et al. Safety of a hybrid closed-loop insulin delivery system in patients with type 1 diabetes. JAMA 2016;316:1407–1408.

Stone MP, Agrawal P, Chen X, et al. Retrospective analysis of 3-month real-world glucose data after the MiniMed 670G system commercial launch. Diabetes Technol Ther 2018; 20(10):689-692.

2 Medtronic data

WARNING: Medtronic performed an evaluation of the MiniMed™ 670G system and determined that it may not be safe for use in children under age 7 because of the way that the system is designed and the daily insulin requirements. Therefore, this device should not be used in anyone under age 7. This device should also not be used in patients who require less than a total daily insulin dose of 8 units per day because the device requires a minimum of 8 units per day to operate safely.