Higher time in range reduces risks for CV events, severe hypoglycemia in type 2 diabetes
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Key takeaways:
- Each 10% increase in time in range in type 2 diabetes lowers risks for major CV events, severe hypoglycemia and microvascular events.
- HbA1c was not linked to any outcomes after adjusting for time in range.
People with type 2 diabetes who spend more time in glycemic range have lower risks for major adverse cardiovascular events, severe hypoglycemia and microvascular events, according to a post hoc analysis of the DEVOTE trial.
“CGM is being used in clinical management for those on insulin, both with type 1 diabetes and type 2 diabetes, and this study supports also following time in range as marker of risk for cardiovascular disease in those with type 2 diabetes,” Richard M. Bergenstal, MD, executive director of the International Diabetes Center at HealthPartners Institute in Minneapolis, told Healio. “It confirmed association of time in range — in our case derived time in range from 8-point glucose profiles — with microvascular disease.”
In the DEVOTE trial, people with type 2 diabetes who had an HbA1c of at least 7% at baseline and were being treated with at least one antihyperglycemic agent were randomly assigned to insulin degludec (Tresiba, Novo Nordisk) or insulin glargine U-100 (Lantus, Sanofi) daily. The study’s primary outcome was the first occurrence of an adjudicated major adverse CV event. In the post hoc analysis, researchers collected data from 5,774 participants who had data available from at least six self-monitoring blood glucose profiles at 1 year. Derived time in range was defined as the percentage of glucose values within target range between 70 mg/dL and 180 mg/dL. Occurrences of major adverse CV events and severe hypoglycemia were collected from the original DEVOTE findings, and microvascular events were obtained from safety reports.
The findings were published in Diabetes Technology & Therapeutics.
At 1 year, 65% of the cohort had a derived time in range of 70% or higher. The mean derived time in range was 74%. There were 370 major adverse CV events and 314 severe hypoglycemia episodes that occurred in the cohort.
Compared with a derived time in range of 50% or less, having a derived time in range of more than 50% or more than 70% was negatively associated with time to first major adverse CV event (P = .0087), severe hypoglycemic episode (P < .0001) or microvascular event (P = .024). Researchers observed a trend between HbA1c at 12 months and time to first major adverse CV event, severe hypoglycemia or microvascular event. However, the trend was not observed when derived time in range was added to the model.
“With HbA1c still the gold standard marker for glycemic risk of developing microvascular complications (and macrovascular in type 1 diabetes), many felt time in range, although a helpful management tool, may not add much to risk profile for vascular complications,” Bergenstal said. “This is one of the first study to show derived time in range actually was more strongly correlated with macrovascular complications in type 2 diabetes than was HbA1c — where we showed adding HbA1c into the model of risk reduction related to derived time in range did not weaken the correlation.”
Among adults with a derived time in range of more than 70%, 5.7% had a major adverse CV event, 4.4% had a severe hypoglycemic event and 3.5% had a microvascular event. For those with a derived time in range between 50% and 70%, 6.7% had a major adverse CV event, 7% had a severe hypoglycemic event and 4.2% had a microvascular event. Among adults with a derived time in range of 50% or less, 8.4% had a major adverse CV event, 7.5% had a severe hypoglycemic event and 5.1% had a microvascular event.
Each 10% increase in derived time in range was associated with a reduced risk for a major adverse CV event (HR = 0.94; 95% CI, 0.9-0.98; P < .05) and a severe hypoglycemic event (HR = 0.9; 95% CI, 0.86-0.93; P < .05). Additionally, each 10% increase in derived time below range increased the risk for severe hypoglycemia (HR = 1.32; 95% CI, 1.18-1.47; P < .0001).
Bergenstal said additional research could be done showing the value of using time in range to achieve ideal glycemic status. He also said the findings build on previous data that should encourage companies to include CGM in trial comparing drugs or other diabetes treatments.
“My sense is we are moving [toward] CGM as the main guide to diabetes management for all individuals on insulin and as studies evolve, likely as a tool used by all people with diabetes to better understand and manage their disease,” Bergenstal said.
For more information:
Richard M. Bergenstal, MD, can be reached at richard.bergenstal@parknicollet.com.
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