Rapid insulin–pramlintide artificial pancreas improves glycemic control in type 1 diabetes
medwireNews: A novel artificial pancreas that delivers both rapid insulin and pramlintide improves glycemic control compared with one that delivers rapid insulin alone, without increasing hypoglycemia rates, in people with type 1 diabetes, Canadian research shows.
The randomized crossover trial included 28 participants (43% female, mean age 25 years, mean glycated hemoglobin 7.8%) who received the rapid insulin plus pramlintide – with the aim of reducing postprandial glucose excursions – and rapid insulin alone, as well as regular insulin plus pramlintide during three 24-hour inpatient visits.
Before each artificial pancreas intervention, patients underwent a 10–14-day open-loop run-in period with the intervention regimen, which allowed the researchers to optimize participants’ insulin therapy parameters, including basal rates, carbohydrate-to-insulin ratios, and insulin sensitivity factors.
Ahmad Haidar and colleagues from McGill University in Montréal, Québec, explain that their novel dual-hormone system “delivers pramlintide, in addition to insulin, in a glucose-responsive, basal-bolus manner, and with a fixed ratio relative to insulin [6 µg of pramlintide per unit of insulin] to mimic a coformulation.”
“The dosing algorithms of the artificial pancreas systems were initialized using basal rates, carbohydrate-to-insulin ratios, and total daily insulin dose at the end of the respective optimization periods,” they add.
The researchers found that the time in glycemic range (3.9–10.0 mmol/L; 70–180 mg/dL) was significantly higher with the rapid insulin and pramlintide artificial pancreas system than with the rapid insulin alone system, at 84% versus 74%, but not with the regular insulin and pramlintide system (69%).
This improvement was due to an increased proportion of time spent in range during the day (08:00–23:00) with the rapid insulin and pramlintide versus rapid insulin alone systems (78 vs 63%). During the night the time spent in range was similar between the two systems (95 vs 94%).
Use of the rapid insulin and pramlintide artificial pancreas was also associated with lower mean glucose, less time spent in hyperglycemia (>10 mmol/L), and lower glucose variability compared with rapid insulin alone, but there were no benefits associated with the regular insulin and pramlintide system.
In addition, during the run-in phase, participants reported higher treatment satisfaction with rapid insulin plus pramlintide than with rapid insulin alone, with the majority (90%) saying that they would use a coformulation of rapid insulin and pramlintide if it were commercially available.
Haidar and team report that the rapid insulin and pramlintide system did not increase the number of hypoglycemic events (<3.3 mmol/L with symptoms or <3.0 mmol/L irrespective of symptoms) relative to the rapid insulin alone system, at 12 and 11 events, respectively.
There was also no substantial increase in reporting of mild or moderate gastrointestinal symptoms. These symptoms were reported after 6% of 108 meals eaten during use of the rapid insulin and pramlintide systems compared with after none of the 112 meals eaten during use of the rapid insulin alone system.
Haidar et al conclude: “Studies with the rapid insulin-and-pramlintide artificial pancreas in free-living outpatient settings are now warranted.”
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