Safety and Feasibility of the OmniPod Hybrid Closed-Loop System in Adult, Adolescent, and Pediatric Patients with Type 1 Diabetes Using a Personalized Model Predictive Control Algorithm
View/ Open
Author
Buckingham, Bruce A.
Forlenza, Gregory P.
Pinsker, Jordan E.
Christiansen, Mark P.
Wadwa, R. Paul
Schneider, Jennifer
Peyser, Thomas A.
Lee, Joon Bok
O'Connor, Jason
Layne, Jennifer E.
Ly, Trang T.
Note: Order does not necessarily reflect citation order of authors.
Published Version
https://doi.org/10.1089/dia.2017.0346Metadata
Show full item recordCitation
Buckingham, B. A., G. P. Forlenza, J. E. Pinsker, M. P. Christiansen, R. P. Wadwa, J. Schneider, T. A. Peyser, et al. 2018. “Safety and Feasibility of the OmniPod Hybrid Closed-Loop System in Adult, Adolescent, and Pediatric Patients with Type 1 Diabetes Using a Personalized Model Predictive Control Algorithm.” Diabetes Technology & Therapeutics 20 (4): 257-262. doi:10.1089/dia.2017.0346. http://dx.doi.org/10.1089/dia.2017.0346.Abstract
Abstract Background: 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. Methods: 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. Results: 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. Conclusions: 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.Other Sources
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5910038/pdf/Terms of Use
This article is made available under the terms and conditions applicable to Other Posted Material, as set forth at http://nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of-use#LAACitable link to this page
http://nrs.harvard.edu/urn-3:HUL.InstRepos:37068323
Collections
- FAS Scholarly Articles [18256]
Contact administrator regarding this item (to report mistakes or request changes)