MiniMed™ 670G System European Real-World Data Shows 73% Time in Range, Beyond Recommended Targets
来源: Nasdaq GlobeNewswire / 18 九月 2019 03:00:04 America/New_York
DUBLIN, Sept. 18, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT), the global leader in medical technology, services and solutions today announced real-world clinical outcomes on European patients for the MiniMed™ 670G system. The European data showed an average Time in Range of 73%1, a result that exceeds the recommended Time in Range consensus guidelines of 70% that were recently published2. The real-world data of 4,369 patients showed an average estimated HbA1c of 6.9%*1, also surpasses the recommended target.3
The SmartGuard™ Auto Mode feature in the MiniMed 670G system automates and personalizes the delivery of basal insulin 24 hours a day. This system is the only commercially available technology in the world to provide protection from highs and lows, and proactively drive increased Time in Range by consistently guiding to the target of 120 mg/dL (6.7mmol/L) throughout the day.4,5
“The Time in Range clinical guidelines recommend that the target of effective diabetes management is the range of 70-180 mg/dL (3.9-10mmol/L) for at least 70% of time. By exceeding this target in a real-world setting, in its first year of use in Europe, the MiniMed 670G system provides additional reassurance to healthcare professionals and their patients as the highest standard of care for diabetes available today,”1,3 said Johan Jendle, M.D., Ph.D., professor at the Institute of Medical Sciences, University Hospital Örebro, Sweden.
"The European real-world data adds to a growing body of evidence that further demonstrates that the MiniMed 670G system improves Time in Range and exceeds recommended clinical targets. This new data demonstrates similar results to the ones of the controlled pivotal trials of the system4,5,6. This is particularly impressive considering these results were achieved in an uncontrolled environment," said Dr. Robert Vigersky, chief medical officer for the Diabetes Group at Medtronic. “The fact that this real-world data exceeds the Time in Range target demonstrates the strong positive outcomes the MiniMed 670G system can drive, also by contributing to the prevention of short and long-term complications of this chronic disease.”1,3
“My life has changed significantly, since I started using the MiniMed 670G system last year,” said Elin Holmlund, 35 years old, from Sweden. “The SmartGuard Auto Mode feature allows me to live more freely, knowing I don’t need to permanently think about the next low or high, and what I can do to try to prevent it. The system takes some of that emotional burden away from me. Since I started using the system, I have fewer lows and highs. My Time in Range is consistently on track and so is my life.”
The MiniMed 670G system real-world European data further demonstrates the system’s ability to provide protection from low sugar levels with people spending on average just 2.3% of time below 70 mg/dL (3.9 mmol/L)1. This surpasses the recommended target of less than 4% of time below 70 mg/dL (3.9 mmol/L)2.
The MiniMed 670G system is now being used by more than 200,000 people worldwide, including more than an estimated 10,000 from across Europe.7 Medtronic began the commercialization of the MiniMed 670G system across the Europe, Middle East and Africa (EMEA) region in October 2018, and the system is currently available in seventeen countries. Most recently, on August 29, 2019, the company secured reimbursement for the MiniMed 670G system with the German Federal Association of the Statutory Health Insurances (GKV-SV).
Time in Range
Time in Range refers to the percentage of time people with diabetes spend in the optimal glycemic range of 70-180 mg/dL (3.9-10 mmol/L). The goal with diabetes management is to increase time spent in this target range and to minimize high and low sugar levels, which can lead to both immediate and long-term complications such as damage to blood vessels - increasing the risk of coronary artery disease and stroke. Damage to blood vessels can also lead to loss of vision, kidney disease, and nerve damage.
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.
1. Medtronic data on file. MiniMed 670G data uploaded voluntarily by 4,369 users in Europe to CareLinkTM Personal, from 01 October 2018 to 14 August 2019
2. Battelino T, et al. Diabetes Care 2019 Aug; 42(8): 1593-1603.
3. ADA Guidelines of A1C<7.0 –www.Diabetes.org.
4. Bergenstal, R. M. et al. Jama. 2016 ; 316 (13) : 1407 – 1408.
5. Garg SK et al. Diabetes Technol Ther. 2017 Mar;19(3):155-163
6. Forlenza GP, et al. Diabetes Technol Ther. 2018;21(1):11-19.
7. Data on file: Estimated patients numbers based upon shipment data 26thAugust 2019
**Estimated HbA1C based on reported mean glucose values at end of study 159mg/dL (8.8 mmol/L) and 154mg/dL (8.6 mmol/L). Calculated using JAEB https://www.jaeb.org/gmi/.
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information,contact your local Medtronic representative.