DUBLIN, June 12, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today presented results from its U.S. pivotal trial of its investigational MiniMed™...
DUBLIN, June 12, 2020 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today presented results from its U.S. pivotal trial of its investigational MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system at the virtual 80th Scientific Sessions of the American Diabetes Association (ADA). The MiniMed 780G system, which features a default target of 100mg/dL (with the option of 120mg/dL), programmable insulin action time from two to eight hours, and automatic corrections every five minutes, met all study endpoints and demonstrated high user satisfaction across the studies being presented today at the conference.
Results of the 90-day at home U.S. pivotal trial, studying adults and adolescents aged 14-75 years old, show the trial successfully met both safety and glycemic endpoints and demonstrated no occurrences of severe adverse events. The trial results include:
Results from a study questionnaire also demonstrated high user satisfaction with 96% indicating it was easy to use. System requests for fingerstick blood sugars were also reduced by 46% when compared to the MiniMed™ 670G system.
Lastly, the lower target glucose and active insulin time (AIT) settings substantially improved Time in Range, without increasing hypoglycemia. Time in Range increased to 76%, with a 100 mg/dL target and AIT of two to three hours and reached 79% when AIT was set to two hours. Results across all pump settings exceeded ADA and ATTD international clinical consensus Time in Range guidelines.
Time in Range
Time in Range
Time in Range
|100 mg/dL default target||2-3 hour active insulin time (AIT)||76%||74%||84%|
|2 hour AIT||79%||76%||87%|
“The results of the study are exciting and are a welcome addition to what we have seen with other advancements in automated insulin delivery systems. Most notable is the additional target glucose level of 100 mg/dL — which will be lower than the other commercially available devices in this category and likely contributed to the demonstrated improvements in study outcomes, namely Time in Range and A1C,” said Dr. Anders Carlson, medical director of the Park Nicollet International Diabetes Center (IDC) in Minneapolis, Minn. and investigator of the study. “We often hear from our patients about wanting lower glucose target settings, and there is certainly a desire to see that represented more in the current marketplace. I’m pleased to see this next generation closed loop system continuing to improve in that direction.”
Data from a second, randomized cross-over clinical trial based in New Zealand studied a more challenging patient group, including those with less-controlled diabetes and a younger patient population of children as young as seven years old, was also presented at the meeting. The results demonstrated improved outcomes for those on the Medtronic AHCL system when compared to a predictive low-glucose management (PLGM) algorithm, even for this patient group which entered the trial at a low baseline. The results included:
The study met primary endpoints (increasing overall Time in Range), as well as secondary endpoints (decreasing overall time above and below range). Patients also reported through a study questionnaire being highly satisfied with their experience overall, with 95% agreeing that the system was easy to use and 85% agreeing that the system improved their quality of life.
“We wanted to design a system that further simplifies diabetes management and provides an extra layer of protection for the times one may forget a pre-meal bolus or miscalculate their carbohydrates,” said Robert Vigersky, M.D., chief medical officer for the Diabetes Group at Medtronic. “The combination of these two study findings, across a broad spectrum of patients at various levels of glucose control, are promising — they demonstrate that the smart automation featured in this next-generation system has tremendous potential for meaningfully reducing burden and enhancing quality of life.”
The investigational MiniMed 780G system is designed to automate the delivery of both basal insulin and correction boluses every five minutes to help people with diabetes avoid highs and lows with greater ease. Bluetooth® connectivity will also enable real-time monitoring of glucose levels and trends on smartphones by both the user and their care partners. Data from the pivotal study will be submitted as part of a future Premarket Approval (PMA) application to the U. S. Food and Drug Administration (FDA) for commercial approval of the MiniMed 780G system in the U.S. In the United States, the MiniMed 780G system is investigational use only, and not approved for sale or distribution. The MiniMed 780G system received CE (Conformité Européenne) Marking in June 2020.
The findings outlined above will be shared at the 80th Scientific Sessions of the American Diabetes Association virtual meeting, June 12-16, 2020:
Other data on the AHCL system at the 80th Scientific Sessions of the American Diabetes Association virtual meeting include:
About the Diabetes Group at Medtronic (www.medtronicdiabetes.com)
Medtronic is working together with the global community to change the way people manage diabetes. The company aims to transform diabetes care by expanding access, integrating care and improving outcomes, so people living with diabetes can enjoy greater freedom and better health.
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies - alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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