WASHINGTON--Patients with type 1 diabetes who use Medtronic's MiniMedTM 670G insulin pump system are able to maintain blood glucose levels in the targeted range over 71% of the time, according to a study that analyzed some 6 million days of real-world data. Results of the industry-supported study were accepted for presentation at ENDO 2020, the Endocrine Society's annual meeting, and will be published in a special supplemental issue of the Journal of the Endocrine Society.
In patients with diabetes, the current goal is to be in the target glucose range of 70-180 mg/dL over 70% of the time.
"Real-world experience does not necessarily live up to the results seen in a clinical trial that recruits highly motivated participants and who are under close supervision," said study principal investigator Robert Vigersky, M.D., chief medical officer of Medtronic Diabetes, Northridge, Calif. "Our results demonstrate that the glycemic [blood glucose] control using the MiniMedTM 670G in the real world is excellent and mirrors the results of the small pivotal trials that led to the system's approval."
Sometimes called an "artificial pancreas," the MiniMed TM 670G system is the first hybrid closed-loop system approved by the U.S. Food and Drug Administration (FDA) for people with type 1 diabetes, Vigersky said. This system consists of an insulin pump with a tiny insulin infusion catheter worn under the skin and a small continuous glucose monitor (CGM) also worn under the skin, whose sensor measures glucose levels every five minutes and sends the result to the pump. The pump then automatically adjusts the amount of insulin given every 5 minutes. The MiniMed TM 670G gained approval in 2016 for people ages 14 and older and in 2018 for children ages 7 to 13 years, he said.
Since then, use of the MiniMed TM 670G has grown to more than 180,000 Americans, according to the study abstract. Many patients have uploaded their sensor glucose data from their devices to a web database called CareLink to track their glycemic control and share their data with their physicians.
In this study, the researchers analyzed information uploaded to the CareLink database from March 2017 to July 2019 by 118,737 persons with type 1 diabetes using the MiniMed TM 670G.
Overall, the percentage of time spent within the target glucose range of 70 to 180 mg/dL was 71.3%, Vigersky reported.
Additionally, the researchers assessed the impact of the system's AutoMode insulin delivery feature in a subgroup of 51,254 individuals who had at least seven days of sensor glucose readings for both Auto Mode turned on and turned off (manual mode). In that subgroup, the percent of time in target glucose range increased from 60.9% in manual mode to 69.9% in Auto Mode, the investigators reported. Both the time spent below (low blood sugar) and above the target glucose range (high blood sugar) decreased in AutoMode, Vigersky said.
Medtronic Diabetes funded the study.
Last month, the U.S. Food & Drug Administration announced Medtronic had recalled MiniMed 670G insulin pumps that have a broken or missing retainer ring following reports that a broken or missing part could lead to incorrect dosing. Insulin pumps with the retainer ring intact do not need to be returned to Medtronic.