Diabetes Dialogue: Breaking Down the Medtronic 780G Approval, with Robert Vigersky, MD

Before closing out April 2023, Medtronic made an announcement some in the US had been waiting years for: the US Food and Drug Administration had granted approval to the MiniMed 780G system for people with type 1 diabetes.

Given a CE Mark from the European Medicine Association more than 2 years earlier, the approval marks the first to a system with meal detection technology and the ability to provide automatic adjustments and corrects to sugar levels every 5 minutes. Featuring a Guardian 4 sensor and requiring no finger sticks while in SmartGuard Technology, the system boasts the strongest clinical outcomes data yet from a Medtronic pump.

Announced on April 21, 2023, the approval indicates the system for use in people with type 1 diabetes aged 7 years or older. In their release, Medtronic called attention to pivotal trial data indicating use of the MiniMed 780G System was associated with a time in range of 70-180 mg/dL of 75%, an overall time below range of 1.8%, an overnight time in range of 82%, and an overnight time below range of 1.5%.

According to Medtronic, the company plans to begin accepting preorders for the new system on May 15, 2023. The company points out those using the MiniMed 770G System will be eligible to upgrade through a no-cost remote software upgrade, but those wishing to use the system will need a prescription to do so.

In this episode of Diabetes Dialogue: Technology, Therapeutics, and Real-World Perspectives, Robert Vigersky, MD, chief medical officer of Medtronic Diabetes, sits down to provide a comprehensive overview of the system, the advantages it provides to patients, plans for nationwide rollout, and more. Later in the episode, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist and coordinator of the Remote Monitoring Program at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, dive deeper into what the approval means for patients, with a focus on accessibility of the system for users.

Relevant disclosures for Dr. Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Dr. Bellini include Abbott Diabetes Care.

References:

1. Campbell P. FDA approves Medtronic’s minimed 780G system for people with type 1 diabetes. HCP Live. April 22, 2023. Accessed May 12, 2023. https://www.hcplive.com/view/fda-approves-medtronic-minimed-780g-system-type-1-diabetes.