UnitedHealthcare Pediatric Expansion
UnitedHealthcare and Medtronic Update
Following the FDA’s expanded approval of the MiniMed™ 670G insulin pump system to include children ages 7 and up, UnitedHealthcare has decided to expand its current preferred insulin pump agreement with the Diabetes Group at Medtronic. Effective February 1, 2019, the MiniMed™ 670G system will be the preferred pump for children age 7 and older receiving a prescription for an insulin pump for the first time as UnitedHealthcare members.
The UnitedHealthcare decision is supported by the comprehensive and rigorous body of clinical trial and real-world data strongly supporting 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 (hypoglycemia) healthy Time in Range versus 6 percent compared to baseline.1
In addition, UnitedHealthcare has reported positive first-year results from the preferred agreement in place with adults which demonstrated reduced hospital admissions for patients using a Medtronic insulin pump, compared to those utilizing multiple daily injections (MDI). After one year, results showed a 27 percent decline in the rate of preventable hospital admissions compared to MDI.
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.
Important Safety Information: MiniMed™ 670G System with SmartGuard™ technology
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, seven years of age 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 fingerstick may be required. A confirmatory finger stick test via the CONTOUR®NEXT 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 CONTOUR®NEXT LINK 2.4 blood glucose meter and not on values provided by the Guardian™ Sensor (3). Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the CONTOUR®NEXT 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.
WARNING: Medtronic performed an evaluation of the MiniMed™ 670G system and determined that it may not be safe for use in children under the age of 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 the age of 7 years old. 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.
Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. The safety of the MiniMed™ 670G system has not been studied in pregnant women. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult http://www.medtronicdiabetes.com/important-safety-information#minimed-670g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library