Real-Time Detection of Infusion Site Failures in a Closed-Loop Artificial Pancreas
| Autor: | Francis J. Doyle, Ravi Gondhalekar, Gregory P. Forlenza, Eyal Dassau, Sunil Deshpande, Tatiana Marcal, B. Wayne Bequette, Juergen Hahn, Lindsey Towers, Jordan E. Pinsker, Trang T. Ly, David M. Maahs, Eric Mauritzen, Daniel P. Howsmon, Lauren M. Huyett, Nihat Baysal, Bruce A. Buckingham |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
Male Pancreas Artificial medicine.medical_specialty Endocrinology Diabetes and Metabolism Biomedical Engineering 030209 endocrinology & metabolism Bioengineering Infusion Site Artificial pancreas Fault detection and isolation Diabetic Ketoacidosis 03 medical and health sciences 0302 clinical medicine Insulin Infusion Systems Internal medicine Internal Medicine medicine Humans Hypoglycemic Agents Insulin 030212 general & internal medicine Type 1 diabetes Cross-Over Studies business.industry Original Articles Middle Aged medicine.disease Model predictive control Diabetes Mellitus Type 1 Cardiology Equipment Failure Female business Closed loop Algorithms |
| Zdroj: | Journal of diabetes science and technology. 12(3) |
| ISSN: | 1932-2968 |
| Popis: | Background:As evidence emerges that artificial pancreas systems improve clinical outcomes for patients with type 1 diabetes, the burden of this disease will hopefully begin to be alleviated for many patients and caregivers. However, reliance on automated insulin delivery potentially means patients will be slower to act when devices stop functioning appropriately. One such scenario involves an insulin infusion site failure, where the insulin that is recorded as delivered fails to affect the patient’s glucose as expected. Alerting patients to these events in real time would potentially reduce hyperglycemia and ketosis associated with infusion site failures.Methods:An infusion site failure detection algorithm was deployed in a randomized crossover study with artificial pancreas and sensor-augmented pump arms in an outpatient setting. Each arm lasted two weeks. Nineteen participants wore infusion sets for up to 7 days. Clinicians contacted patients to confirm infusion site failures detected by the algorithm and instructed on set replacement if failure was confirmed.Results:In real time and under zone model predictive control, the infusion site failure detection algorithm achieved a sensitivity of 88.0% (n = 25) while issuing only 0.22 false positives per day, compared with a sensitivity of 73.3% (n = 15) and 0.27 false positives per day in the SAP arm (as indicated by retrospective analysis). No association between intervention strategy and duration of infusion sets was observed ( P = .58).Conclusions:As patient burden is reduced by each generation of advanced diabetes technology, fault detection algorithms will help ensure that patients are alerted when they need to manually intervene.Clinical Trial Identifier:www.clinicaltrials.gov,NCT02773875 |
| Databáze: | OpenAIRE |
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