Outpatient use of a novel adaptive artificial pancreas system resulted in significant improvement in hemoglobin A1C (HbA1C) level and a reduction in hypoglycemia in people with type 1 diabetes, according to a multicenter trial published in Diabetes Care.
Study authors recruited 29 people diagnosed with type 1 diabetes at least 1 year previously. Participants had been using an insulin pump for at least 6 months and had a mean baseline HbA1C level of 7.0%±0.8%. All patients completed a continuous glucose monitor-augmented 1-week run in with a sensor-augmented pump and 12 weeks of artificial pancreas (AP) system use. Adaptations to the delivery of basal insulin were made weekly, and carbohydrate ratios were adapted every 4 weeks and reviewed by the investigators and participants.
After 12 weeks, the primary end point of the study was met, with the mean HbA1C level improving to 6.7%±0.6% (-0.3; P <.001). Compared with the run-in period, the percentage of time spent in the hypoglycemic range during the day improved from 5.0% to 1.9% (-3.1; P <.001) and during the night from 4.1% to 1.1% (-3.1; P <.001). Basal insulin level was adapted throughout the study and carbohydrate ratios were adapted early on with minimal subsequent changes. Ninety percent of the algorithmic adaptations were accepted, with most manual overrides occurring because of concern for hyperglycemia or hypoglycemia when a patient changed his or her routine, and no protocol-related serious adverse events were reported.
This study used a completely automated, cloud-based computing system that seamlessly integrated data from the AP into an algorithmic adaptation framework for measurement of basal rates and carbohydrate ratios without the need for clinician or patient involvement. The investigators concluded by stating, “We found that outpatient use of an AP system for 12 weeks, with algorithmic adaptation and eventual optimization of insulin delivery parameters, has the potential to deliver enormous benefits….Continued study of ways to improve adaptation of AP systems is needed.”
Dassau E, Pinsker JE, Kudva YC, et al. 12-week 24/7 ambulatory artificial pancreas with weekly adaptation of insulin delivery settings: effect on hemoglobin A1c and hypoglycemia [published online October 13, 2017]. Diabetes Care. doi:10.2337/dc17-1188