medwireNews: Automated insulin delivery (AID) significantly reduces glycated hemoglobin (HbA1c) levels in people with type 2 diabetes who are already using insulin, regardless of their socioeconomic, racial, ethnic, and clinical backgrounds, US researchers report.
The study, carried out at 21 clinical centers in the USA, included 305 adults with type 2 diabetes (mean age 57 years, 57% women, 50% non-Hispanic White, 24% non-Hispanic Black, 22% Hispanic/Latino) who had been using insulin for at least 3 months.
At baseline, 73% were using multiple daily insulin injections, 21% were using basal insulin without bolus, and 6% were using an insulin pump without AID. In addition, 62% were using continuous glucose monitoring (CGM), while 55% were using glucagon-like peptide-1 receptor agonists, 44% were using sodium-glucose transport protein 2 inhibitors, and 27% both types of agent.
After an initial 14-day standard therapy phase during which baseline CGM data were collected, the participants underwent 13 weeks of treatment with the Omnipod 5 AID System (Insulet Corporation, Acton, Massachusetts, USA). The system delivers dynamic microboluses of insulin every 5 minutes or pauses insulin when CGM-measured glucose values approach a user-determined target glucose value of 110–150 mg/dL (6.1–8.3 mmol/L).
Francisco Pasquel (Emory University, Atlanta, Georgia) and co-investigators report that, after 13 weeks of AID use, mean HbA1c levels had fallen significantly from 8.2% (66 mmol/mol) at baseline to 7.4% (57 mmol/mol) at follow-up, with the mean reduction of 0.8 percentage points meeting the prespecified criteria for both noninferiority and superiority compared with baseline.
Subgroup analyses showed that the benefit of AID was consistent across a wide range of participant characteristics including sex, age, socioeconomic status, pretrial mealtime insulin regimen, noninsulin glucose-lowering medication use, C-peptide level, and previous CGM use.
The benefit of AID was significantly greater among participants with a higher baseline HbA1c. Specifically, those with baseline HbA1c of 9.0% (75 mmol/mol) or greater had a mean decrease of 2.1 percentage points at 13 weeks, whereas those with baseline HbA1c level of less than 7.0% (53 mmol/mol) did not experience a decrease during AID treatment.
In addition, the team observed an apparent interaction between change in HbA1c and race and ethnicity. After adjustment for baseline HbA1c, non-Hispanic Black participants had a lower mean reduction in HbA1c than non-Hispanic White and Hispanic/Latino participants, at 0.5 versus 0.9 and 1.0 percentage points, respectively.
Nonetheless, Pasquel et al stress that “all racial and ethnic groups saw benefit,” and further analysis indicated that non-Hispanic Black participants were less likely to adopt the 110 mg/dL target than non-Hispanic White or Hispanic/Latino participants (37 vs 56 and 55%, respectively).
Among the secondary outcomes measured, the researchers found that time in target glucose range (70–180 mg/dL; 3.9–10.0 mmol/L) increased significantly from a mean of 45% at baseline to 66% at week 13, corresponding to an additional 4.8 hours/day in target range with AID.
There was also a significant decrease from baseline to week 13 in the percentage of time in hyperglycemic range (54 vs 34% for >180 mg/dL; 10.0 mmol/L) and no significant change in the time spent in hypoglycemic range (0.2 vs 0.2% for <70 mg/dL; 3.9 mmol/L and 0.0 vs 0.0% for <54 mg/dL; 3.0 mmol/L).
There was one severe hypoglycemia episode during the AID phase of the study, and no cases of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome.
Discussing their findings, the researchers acknowledge the lack of a control group, and that some, but not all, of the HbA1c improvement they observed with AID could be due to the addition of CGM or study effect alone.
Even so, they conclude in JAMA Network Open that “AID may be a beneficial and safe option for people with type 2 diabetes using insulin.”
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