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Predictive controller reduced hypoglycemia in feasibility study
SAN FRANCISCO — The use of a predictive controller reduced hypoglycemia, shedding light on insulin dosing behaviors in patients with type 1 diabetes, according to data presented here.
“Our objective was to investigate automated insulin delivery characteristics of predictive controlling in response to [continuous glucose monitoring] levels, based on the ‘aggressiveness’ factor and gain insight into glucose control performance. We certainly want to gain insight into the potential glucose control performance when this product becomes a reality,” Daniel A. Finan, PhD, of Animas Corp. in West Chester, Pa., said during a presentation at the American Diabetes Association’s 74th Scientific Sessions.
Finan and colleagues conducted the non-randomized uncontrolled clinical research center-based feasibility study of 12 patients with type 1 diabetes in an effort to examine the hypoglycemia reduction capability and insulin dosing behavior of a predictive controller when the aggressiveness was varied among conservative, medium and aggressive settings, according to Finan.
Results indicated that the controller and a downstream safety module dosed insulin automatically based on CGM values to minimize exposure to glucose <70 mg/dL. In addition, the researchers observed a median percentage (interquartile range) of total closed-loop time spent at glucose values <70 mg/dL based on CGM was 0% (0-1.6%), according to data.
The dosing characteristics were examined for time-in-range when glucose was between 90 mg/dL and 120 mg/dL and decreasing, Finan said.
Moreover, the conservative controller’s average recommendation was only 3% less than the corresponding basal dose, compared with the medium and aggressive controllers at 14% less and 19% less, according to data.
“In the algorithm of aggressiveness, the conservative controller was probably too conservative. These results were well worth the study in and of itself because we had gone into the study thinking this conservative value was a default value,” Finan said “We saw that when compared to other values, it didn’t look so great. On the other hand, the medium and aggressive controls were much more aligned with our expectations. We were encouraged, especially with hypoglycemia metrics in glucose outcomes. However, we recognized our study limitations which are that it included a small number of patients and clinical research center environment.”— by Samantha Costa
Disclosure: Finan reports employment with the Animas Corp. and being a stock/shareholder with Johnson & Johnson.
For more information: Finan DA. Abstract 232-OR. Presented at: American Diabetes Association’s 74th Scientific Sessions; June 13-17, 2014; San Francisco.