FDA Approves Medtronic MiniMed™ 780G System - World's First Insulin Pump with Meal Detection Technology* Featuring 5-Minute Auto Corrections†§
"Mealtimes prove to be one of the biggest challenges for people living with type 1 diabetes and now for the first time, the MiniMed 780G system addresses this unmet need with automatic, real-time insulin corrections," said Que Dallara, EVP and President of
Key System Features
The MiniMed 780G system features the lowest glucose target setting (as low as 100 mg/dL) in any automated insulin pump on the market1 and one that more closely mirrors the average glucose of someone not living with diabetes. With this setting, the pump will "treat to target" and will automatically deliver basal insulin adjustments and autocorrections to a set target. It's also the only pump with an infusion set that can be worn for up to 7 days, doubling wear time** with advanced materials that help reduce insulin preservative loss, maintain insulin flow and stability, resulting in a reduced risk of infusion set occlusion.2 Combined with the new Guardian™ 4 sensor requiring no fingersticks with SmartGuard™ technology‡, the MiniMed 780G system delivers a user-friendly design with 94% of users saying they're satisfied with the impact the system has on their quality of life3. Importantly, users also reported remaining in SmartGuard™ technology 95% of the time4.
"My last two years on the MiniMed 780G system as part of the clinical trial have been incredible for me," said
Results from the randomized controlled ADAPT study evaluating the performance of the MiniMed 780G system1 against multiple daily injections (MDI) used in conjunction with an intermittently scanned CGM (isCGM) reinforced the significant benefits of automated insulin therapy over standard therapy. Initial 6-month results, published in The Lancet Diabetes & Endocrinology, showed AHCL system users experienced a 27.6% increase in Time in Range (TIR) and 1.4% reduction in HbA1C compared to those on MDI + isCGM without increased time in hypoglycemia. This improvement was even greater overnight with a TIR increase of 30.2%. At the close of the 6-month study period, all participants on MDI + isCGM crossed over to the MiniMed 780G system. At one year, these significant improvements were reproduced in this cross-over group and sustained in those that started on AHCL therapy at the start of the trial.
The system is approved for users seven years old and above with type 1 diabetes. Medtronic will begin taking pre-orders on
*Taking a bolus 15 – 20 minutes before a meal helps to keep blood sugar levels under control after eating.
† Refers to auto correct, which provides bolus assistance. Can deliver all auto correction doses automatically without user interaction, feature can be turned on and off.
§ Refers to SmartGuard™ feature. Individual results may vary.
**The extended wear infusion set can be worn for up to 7 days. Current infusion sets are recommended for up to 3 days of wear.
‡ Fingersticks required in manual mode & to enter SmartGuard™. If symptoms don't match alerts & readings, use a fingerstick. Refer to user guide. Pivotal trial participants spend avg of > 93% in SmartGuard™.
1. Arrieta A, et al. Diabetes Obes Metab. 2022;10.1111/dom.14714
2. Zhang G, et al. Development of the Extended Infusion Set and Its Mechanism of Action. J Diabetes Sci Technol. 2022 Jul 25:19322968221112120. doi: 10.1177/19322968221112120. Epub ahead of print. PMID: 35876264.
3. Medtronic data on file: MiniMed™780G users survey conducted in April – May 202in
4. Carlson, A.L. et al. Safety and glycemic outcomes of the MiniMed™ AHCL system in subjects with T1D. Diab Tech Ther. ahead of print http://doi.org/10.1089/dia.2021.0319
5. Data on file from CIP 321: Pivotal Trial (Age 14- 75). N=152. 2020; 16 US sites.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the
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