An Endocrine News roundup of the week’s pharmaceutical news, breakthroughs, and general information. *
FDA Approves MiniMed 780g System for Adults with Type 2 Diabetes
On September 2, Medtronic announced two U.S. Food and Drug Administration (FDA) regulatory milestones that broaden the MiniMed™ 780G system portfolio: clearance of the SmartGuard™ algorithm as an interoperable automated glycemic controller (iAGC), enabling integration with the Instinct sensor, made by Abbott, for type 1 diabetes, and approval of the MiniMed™ 780G system for use in adults 18+ with insulin-requiring type 2 diabetes.
“These milestones mark an important next step in our work to bring the proven performance and outcomes of our MiniMed™ 780G automated insulin delivery system to more people living with diabetes. By enabling integration with the Instinct sensor and expanding the MiniMed™ 780G system to people with type 2 diabetes, we are advancing a smart dosing ecosystem designed to provide greater choice and flexibility, along with a more seamless experience,” said Que Dallara, Executive Vice President and President of Medtronic Diabetes and CEO Designate of MiniMed. “We’re excited to expand our ecosystem of solutions under one roof with service our customers can count on around the clock.”
This clearance, alongside the previously cleared MiniMed™ 780G insulin pump as an alternate controller enabled (ACE) pump, completes the Medtronic FDA pre-market approval pathway for the Instinct sensor integration with our MiniMed™ 780G system for people living with type 1 diabetes. The Instinct sensor, designed exclusively by Abbott for MiniMed™ automated insulin delivery (AID) and Smart MDI systems, is the world’s smallest1,2, thinnest1, most discreet2 integrated CGM (iCGM) and offers a wear time of up to 15 days.
In the coming weeks, Medtronic and Abbott plan to complete their required compliance documentation enabling sensor integration and marketing. Completion of this step will promptly finalize the regulatory process, after which ordering for the Instinct sensor with the MiniMed™ 780G system will begin. Existing customers will have priority access through the Innovations Program. Pre-orders for Simplera Sync™ sensor will also begin later this month.
“We’re working together to do what’s best for people living with diabetes,” said Chris Scoggins, Executive Vice President of Abbott’s diabetes care business. “Abbott’s biowearable technology has long set the standard for accurate, accessible, easy-to-use continuous glucose monitoring. Connecting it with the MiniMed™ 780G system aims to reduce the mental load of daily management, making it easier for people to live with diabetes.”
Expanding Indications for Type 2 Diabetes
Separately, the FDA approved the MiniMed™ 780G system for people with insulin-requiring type 2 diabetes, making it the first and only automated insulin delivery (AID) system with Meal Detection™ technology* available to this population.
“This approval extends the benefits of automated insulin delivery to people with type 2 diabetes,” said Natalie Bellini, DNP, FNP, BC-ADM, CDCES, Endocrine Nurse Practitioner and Program Director for Diabetes Technology at University Hospitals in Cleveland, Ohio. “It also aligns with the ADA Standards of Care, which now formally endorse AID systems for individuals with type 2 diabetes on intensive insulin therapy.”
People living with type 2 diabetes who require insulin face daily challenges that affect both their physical health and emotional well-being, including frequent injections, meal planning, and glucose monitoring. Clinical evidence demonstrates that use of the MiniMed™ 780G system can improve glycemic outcomes and reduce treatment burden.
- In a recently published pivotal trial3 (n=95) with the Guardian™ 4 sensor and Simplera Sync™ sensor, participants experienced a 0.7% reduction in HbA1c (from a baseline of 7.9%) and an increase in Time in Range to 81% (from a baseline of 72%), with minimal hypoglycemia.
- In a separate single-arm study4 (n=236), A1C decreased from 7.7% to 6.9%, and Time in Range increased from 76.4% to 84.9% during 90 days of advanced hybrid closed-loop use with low time-below-range (70 mg/dL) of 0.3%. Participants also reported improvements in quality of life and reductions in diabetes distress.
The MiniMed™ 780G system is currently available for type 2 diabetes with the Guardian™ 4 sensor and will be available with Simplera Sync™ sensor when pre-orders begin later this month. Medtronic also plans to submit 510(k) applications seeking clearance for an interoperable pump indicated for type 2 diabetes, which would enable future integration with the Instinct sensor.
First Successful Procedures in PRECISE Benign Thyroid Nodule (BTN) Study
On September 2, Pulse Biosciences, Inc., announced the first successful procedures in a multicenter IRB-approved study using Pulse Biosciences’ nsPFA™ Percutaneous Electrode System for the treatment of benign thyroid nodules (BTNs).
“Successful procedures for the first enrolled patients in our PRECISE-BTN clinical study for the treatment of benign thyroid nodules (BTNs) marks a significant milestone not only for Pulse Biosciences but also for the broader medical community and patients who stand to benefit from this organ-sparing technology,” said Dr. Ralph P. Tufano, director of Head and Neck Endocrine Surgery at Sarasota Memorial Hospital (SMH) in Sarasota, Florida, and principal investigator for the PRECISE-BTN study conducted through SMH’s Kolschowsky Research and Education Institute and Brian D. Jellison Cancer Institute. “The objective of this multicenter clinical study is to continue to build clinical evidence in support of this patient-friendly procedure by showing we can safely reduce the debilitating symptoms caused by BTNs, while preserving thyroid function and avoiding complete thyroid removal. Our first two procedures were successful, and we are showing early positive results. We look forward to providing further updates as patients progress.”
The PRECISE-BTN study is a prospective, single arm, multicenter, clinical study using the Pulse Biosciences nsPFA™ Percutaneous Electrode System for the treatment of BTNs. Benign thyroid nodule soft tissue ablation procedures will be performed on up to 50 patients with the nsPFA™ Percutaneous Electrode System across four sites. Per study protocols, patients will be observed and evaluated in follow-up visits to assess the procedure at 1, 3, 6 and 12 months post procedure. Study endpoints evaluated during the follow-up timepoints include safety, targeted nodule volume reduction, symptom reduction, and improvements in quality of life and cosmesis.
“In addition to the remarkable work done to enroll and treat our first patients in the PRECISE-BTN multicenter clinical study, we continue to successfully treat patients through the pilot phase of our commercial launch,” said Paul LaViolette, CEO and Co-Chairman of Pulse Biosciences. “The progression of our clinical studies highlights our commitment to advancing patient treatment and providing valuable insights and outcomes in our field.”
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