Abstract

The safety and feasibility of the OmniPod personalized model predictive control (MPC) algorithm in adult, adolescent, and pediatric patients with type 1 diabetes were investigated.This multicenter, observational trial included a 1-week outpatient sensor-augmented pump open-loop phase and a 36-h inpatient hybrid closed-loop (HCL) phase with announced meals ranging from 30 to 90?g of carbohydrates and limited physical activity. Patients aged 6-65 years with HbA1c between 6.0% and 10.0% were eligible. The investigational system included a modified version of OmniPod, the Dexcom G4 505 Share® AP System, and the personalized MPC algorithm running on a tablet computer. Primary endpoints included sensor glucose percentage of time in hypoglycemia <70?mg/dL and hyperglycemia >250?mg/dL. Additional glycemic targets were assessed.The percentage of time <70?mg/dL during the 36-h HCL phase was mean (standard deviation): 0.7 (1.7) in adults receiving 80% meal bolus (n?=?24), and 0.7 (1.2) in adults (n?=?10), 2.0 (2.4) in adolescents (n?=?12), and 2.0 (2.6) in pediatrics (n?=?12) receiving 100% meal bolus. The overall hypoglycemia rate was 0.49 events/24?h. The percentage of time >250?mg/dL was 8.0 (7.5), 3.6 (3.7), 4.9 (6.3), and 6.7 (5.6) in the study groups, respectively. Percentage of time in the target range of 70-180?mg/dL was 69.5 (14.4), 73.0 (15.0), 72.6 (15.5), and 70.1 (12.3), respectively.The OmniPod personalized MPC algorithm performed well and was safe during day and night use in adult, adolescent, and pediatric patients with type 1 diabetes. Longer term studies will assess the safety and performance of the algorithm under free living conditions with extended use.

View details for DOI 10.1089/dia.2017.0346

View details for Web of Science ID 000424848600001

View details for PubMedID 29431513

View details for PubMedCentralID PMC5910038