Real-world data on artificial pancreas show time-in-range benefit
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More than 100,000 children and adults with type 1 diabetes using a hybrid closed-loop insulin delivery system maintained a blood glucose level in the recommended range 71.3% of the time and experienced an improvement in time in range when using the device in automode, according to a real-world analysis accepted for presentation at the Endocrine Society Annual Meeting.
“Overall, this study underscores the benefits of the MiniMed 670G system, including its ability to help prevent against highs and lows and maintain recommended time in glucose range,” Robert Vigersky, MD, chief medical officer of Medtronic Diabetes in Northridge, California, told Healio. “Our insulin pump technology that automatically adjusts background insulin every 5 minutes based on each person’s unique needs continues to show key benefits for those that use it.”
The FDA extended approval of the MiniMed 670G hybrid closed-loop system (Medtronic) to children aged 7 to 13 years with type 1 diabetes in June 2018. The closed-loop system was originally granted FDA approval in September 2017 for use by people aged 14 years and older.
Real-world sensor data
Vigersky and colleagues analyzed aggregated 5-minute instances of sensor glucose data uploaded to the Medtronic CareLink database between March 2017 and July 2019 by children (aged at least 7 years) and adults with type 1 diabetes who enabled automode on the device (n = 118,737). Researchers analyzed automode data to determine the mean percentage of overall time spent below the recommended blood glucose range (< 70 mg/dL and < 54 mg/dL); as well as time in the recommended blood glucose range (70-180 mg/dL) and time spent above the recommended blood glucose range (> 180 mg/dL and > 250 mg/dL).
Researchers also assessed automode data for a subgroup of 51,254 individuals with at least 7 days of sensor glucose data when automode was turned on and off (manual mode).
Researchers evaluated the percentage of time spent in range, time spent below range, time spent above range and the associated glucose management indicator for the overall “off” (2,524,570 days) and “on” (6,308,806 days) periods across different age groups.
“Findings based on real-world data, outside of a controlled clinical trial, demonstrate the effectiveness of MiniMed 670G on a large scale, across a wide variety of everyday challenges,” Vigersky said. “Individuals with diabetes don’t live their lives within the confines for a clinical study environment, which is why it is so important that the results we see there translate into real life when there is not close supervision.”
Researchers found that mean time spent in range for MiniMed users was 71.3%; percentage of time spent below 54 mg/dL and below 70 mg/dL was 0.4% and 1.9%, respectively; and percentage of time spent above 180 mg/dL and above at least 250 mg/dL was 26.8% and 6.2%, respectively.
User-wise data of automode vs. manual mode showed a mean of 70.3% of the time spent in automode, during which time-in-range increased from 60.9% to 69.9%, according to researchers.
Increase in recommended glucose range
For children aged 7 to 13 years (n = 1,417), time in range increased from 48.7% to 61.5%; time spent below 54 mg/dL and below 70 mg/dL increased from 0.5% to 0.6% and from 2% to 2.2%, respectively; and time spent above 180 mg/dL and above 250 mg/dL decreased from 49.3% to 36.3% and from 20.5% to 13%, respectively.
For adolescents and young adults aged 14 to 21 years (n = 4,194), time in range increased from 51% to 61.5%; time spent below 54 mg/dL and below 70 mg/dL decreased from 0.7% to 0.6% and from 2.3% to 2%, respectively; and time spent above 180 mg/dL and above 250 mg/dL decreased from 46.7% to 36.5% and from 18.5% to 12.5%, respectively.
For adults aged at least 22 years (n = 45,643), time in range increased from 62.2% to 70.9%; time spent below 54 mg/dL and below 70 mg/dL decreased from 0.7% to 0.5% and from 2.6% to 1.9%, respectively; and time spent above 180 mg/dL and above 250 mg/dL decreased from 35.2% to 27.3% and from 9.9% to 6.3%, respectively.
Compared with using the device in manual mode, the mean glucose management indicator when the device was in automode decreased by 0.23% for the overall cohort, by 0.48% for children aged 7 to 13 years, by 0.35% for adolescents and young adults aged 14 to 21 years, and by 0.22% for adults aged at least 22 years.
“The new study analyzed some 6 million days of real-world data and found that patients with type 1 diabetes who use our MiniMed 670G insulin pump system are able to maintain blood glucose levels in the targeted range over 71% of the time,” Vigersky said. “The current goal is to be in the target glucose range of 70 mg/dL to 180 mg/dL over 70% of the time, so this is meaningful because it shows that the system can achieve this across a large sample size and in a real-world setting.”
As Healio previously reported, in November, Medtronic recalled any MiniMed insulin pumps that had a loose, missing or broken retainer ring, which helps to lock the insulin cartridge in place in the pump’s reservoir compartment. In a press release, the FDA stated that if the insulin cartridge is not locked firmly in place, under- or over-delivery of insulin may occur, which could result in hypoglycemia or hyperglycemia. The agency identified the issue as a class I recall, the most serious type of recall, which indicates that use of such devices may cause serious injuries or death. – by Regina Schaffer
Reference:
Vigersky R, et al. OR30-01. The Endocrine Society Annual Meeting; 2020 (conference canceled/virtual meeting).
Disclosure: Medtronic funded this study. Vigersky is chief medical officer for Medtronic Diabetes.