Faye M. Cameron , PhD , 1 , Trang T. Ly , MD 2 , Bruce A. Buckingham , MD 2 , David M. Maahs , MD, PhD 2, , 3 , Gregory P. Forlenza , MD 3 , Carol J. Levy , MD, CDE 4 , David Lam , MD 4 , Paula Clinton , RD, CDE 2 , Laurel H. Messer , RN, MPH, CDE 3 , Emily Westfall , BS, BA 3 , Camilla Levister , ANP, CDE 4 , Yan Yan Xie , MD 4 , Nihat Baysal , PhD 1 , Daniel Howsmon , BS 1 , Stephen D. Patek , PhD 5 , B. Wayne Bequette , PhD 1
01 September 2017
Objective: A fully closed-loop insulin-only system was developed to provide glucose control in patients with type 1 diabetes without requiring announcement of meals or activity. Our goal was to assess initial safety and efficacy of this system.
Research Design and Methods: The multiple model probabilistic controller (MMPPC) anticipates meals when the patient is awake. The controller used the subject's basal rates and total daily insulin dose for initialization. The system was tested at two sites on 10 patients in a 30-h inpatient study, followed by 15 subjects at three sites in a 54-h supervised hotel study, where the controller was challenged by exercise and unannounced meals. The system was implemented on the UVA DiAs system using a Roche Spirit Combo Insulin Pump and a Dexcom G4 Continuous Glucose Monitor.
Results: The mean overall (24-h basis) and nighttime (11 PM–7 AM) continuous glucose monitoring (CGM) values were 142 and 125 mg/dL during the inpatient study. The hotel study used a different daytime tuning and manual announcement, instead of automatic detection, of sleep and wake periods. This resulted in mean overall (24-h basis) and nighttime CGM values of 152 and 139 mg/dL for the hotel study and there was also a reduction in hypoglycemia events from 1.6 to 0.91 events/patient/day.
Conclusions: The MMPPC system achieved a mean glucose that would be particularly helpful for people with an elevated A1c as a result of frequent missed meal boluses. Current full closed loop has a higher risk for hypoglycemia when compared with algorithms using meal announcement.