Breakthrough in diabetes management took strong partnerships and willing trial participants.
The cellphone of an average teenager is a flurry of sent and received text messages. But there is one text message in particular that 16-year old Tia Geri will remember for a long time.
“I was between classes and my mom texted me,” she recalls. “I was like – no way.”
That text contained a word that could someday be a difference maker for millions of people living with type-1 diabetes.
“I was so excited,” says Tia. “This was approved months before anyone thought it would be.”
Just 104 days after submission by Medtronic, the U.S. Food and Drug Administration approved what many in the industry were calling “a breakthrough in diabetes management” – the Medtronic MiniMed 670G. Launched commercially in the United States on June 7, 2017 and available to patients 14 and older, it’s the world’s first hybrid closed-loop system and the most advanced insulin pump and sensor to date.
Very few teenagers get excited about news from the FDA, but Tia isn’t your average teenager. She participated in the MiniMed 670G clinical trial.
“It’s fun using the cutting-edge technology,” she says. “I love doing clinical trials, studies, giving feedback, and making devices safe for people in the future.”
She called the MiniMed 670G a “life-changer.” And that kind of reaction was likely one of the reasons why the system gained FDA approval much earlier than expected.
“It’s the culmination of years of hard work,” says Alejandro Galindo, president of Intense Insulin Management for the Diabetes Group at Medtronic. “The speed by which the FDA approved our application is truly unprecedented. That speaks volumes about the potential impact this innovative therapy can have.”
Medtronic leaders are quick to point out it took an entire network of partnerships to ensure this technology could get to the market.
“We’ve had incredible collaboration with the FDA,” says Hooman Hakami, executive vice president and president of Medtronic Diabetes. “We worked tirelessly with the diabetes community, with JDRF, with patients, and with clinicians to develop this product.”
Hakami calls the MiniMed 670G a “once in a decade product.”
“We have an incredible sense of pride knowing we can make a difference for people like Tia and others like her,” he says. “But this is just a start. We will continue to innovate and help improve diabetes management.”
Improving the lives of patients is just the kind of thing that excites Tia, too. Together, Tia and her mother are active in the diabetes community, even starting CarbDM, a non-profit organization that provides a supportive community for those dealing with the disease.
“It feels really good to know that I had a hand in helping people,” says Tia. “And I’m excited for the people who will get to use this new device.”
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, fourteen 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. Do not 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.
Only use rapid acting U100 insulin with this system. 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, including product and important safety information concerning the 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.