CGM metrics comparable in type 1 diabetes with insulin glargine, insulin degludec
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Adults with type 1 diabetes using insulin glargine had comparable continuous glucose monitoring metrics at 12 weeks as those who used insulin degludec, according to a presenter.
In a subanalysis of data from the InRange trial presented at the International Conference on Advanced Technologies & Treatments for Diabetes, adults wearing a masked CGM for 20 days had a similar time in range between 70 mg/dL and 180 mg/dL, regardless of whether they used insulin glargine or insulin degludec. Additionally, CGM detected more than three times more cases of hypoglycemia than what participants reported through self-measured plasma glucose. Richard M. Bergenstal, MD, executive director of the International Diabetes Center Park Nicollet and Health Partners in Minneapolis, said the findings lend support for the use of CGM metrics in clinical trials.
“We’re using CGM, time in range and time below range in our practices,” Bergenstal said during a presentation. “Variables like time in range, time below range and coefficient of variation are what we use every day to guide therapy, so isn’t it time that these metrics be included in clinical trials?”
Bergenstal and colleagues enrolled 343 adults aged 18 to 70 years with type 1 diabetes and an HbA1c between 7% and 10% to participate in a multicenter, randomized, parallel-group, open-label trial (mean age, 42.8 years; 46.6% women). Participants were randomly assigned to insulin glargine 300 U/mL (Toujeo, Sanofi; n = 172) or insulin degludec 100 U/mL (Tresiba, Novo Nordisk; n = 171) for 12 weeks. Masked CGMs were worn for 20 days during a run-in period prior to randomization and again during the final 20 days of the treatment period. Mean glucose, glucose management indicator, time in range, time above range and time below range were collected.
There was no difference in glucose variability between the two groups. The insulin glargine group had a mean glucose of 174.9 mg/dL at 12 weeks, similar to the mean glucose of 167.8 mg/dL for adults receiving insulin degludec. Glucose management indicator at 12 weeks was similar between the two groups.
Time in range between 70 mg/dL and 180 mg/dL was similar at 51.9% for adults receiving insulin glargine and 55.4% for those receiving insulin degludec at 12 weeks. The findings were unchanged when a tighter time in range between 70 mg/dL and 140 mg/dL was used. Time above range and time below range were also similar between the two groups. Time in range remained similar between insulin glargine and insulin degludec during both daytime and nighttime hours.
CGM-derived hypoglycemia rates with a glucose level of less than 70 mg/dL were 2.9 times higher than self-measured plasma glucose hypoglycemia rates for those using insulin glargine and 3.3 times higher for those using insulin degludec. The differences were starker during overnight hours, where CGM-derived hypoglycemia rates were more than five times higher than self-measured plasma glucose hypoglycemia rates.
“You would expect it to be different, but there aren’t many studies that have actually taken the same period of time and collected both sets of data to document that,” Bergenstal said. “If you want to talk about hypoglycemia, you should really be talking about CGM-based hypoglycemia, not self-reported or finger-stick hypoglycemia.”
During the Q&A session, Bergenstal said the findings could provide evidence to allow regulatory agencies to consider permitting CGM metrics to be used as primary outcomes for clinical trials.
“This is a tool that’s here to stay, and we depend on it for management,” Bergenstal said. “Why shouldn’t it be available in package inserts and with drugs?”
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Bergenstal R, et al. OP 033. Presented at: International Conference on Advanced Technologies & Treatments for Diabetes; Feb. 22-25, 2023; Berlin (hybrid meeting).
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