Development of a Real-time Force-based Algorithm for Infusion Failure Detection.

Autor: Blanco LE; Diatech Diabetes, Inc., Memphis, TN, USA., Wilcox JH; Diatech Diabetes, Inc., Memphis, TN, USA., Hughes MS; Stanford University, Stanford, CA, USA., Lal RA; Stanford University, Stanford, CA, USA.
Jazyk: angličtina
Zdroj: Journal of diabetes science and technology [J Diabetes Sci Technol] 2024 Nov; Vol. 18 (6), pp. 1313-1323. Date of Electronic Publication: 2024 Apr 23.
DOI: 10.1177/19322968241247530
Abstrakt: Background: Continuous subcutaneous insulin infusion (CSII) is a common treatment option for people with diabetes (PWD), but insulin infusion failures pose a significant challenge, leading to hyperglycemia, diabetes burnout, and increased hospitalizations. Current CSII pumps' occlusion alarm systems are limited in detecting infusion failures; therefore, a more effective detection method is needed.
Methods: We conducted five preclinical animal studies to collect data on infusion failures, utilizing both insulin and non-insulin boluses. Data were captured using in-line pressure and flow rate sensors, with additional force data from CSII pumps' onboard sensors in one study. A novel classifier model was developed using this dataset, aimed at detecting different types of infusion failures through direct utilization of force sensor data. Performance was compared against various occlusion alarm thresholds from commercially available CSII pumps.
Results: The testing dataset included 251 boluses. The Bagging classifier model showed the highest performance metrics among the models tested, exhibiting high accuracy (96%), sensitivity (94%), and specificity (98%), with lower false-positive and false-negative rate compared with traditional occlusion alarm pressure thresholds.
Conclusions: Our study developed a novel non-threshold classifier that outperforms current occlusion alarm systems in CSII pumps in detecting infusion failures. This advancement has the potential to reduce the risk of hyperglycemia and hospitalizations due to undetected infusion failures, offering a more reliable and effective CSII therapy for PWD. Further studies involving human participants are recommended to validate these findings and assess the classifier's performance in a real-world setting.
Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: LEB and JHW are full-time employees of Diatech Diabetes, Inc. MSH has consulted for Dexcom and has received research support from Insulet and Tandem. RAL receives consulting fees from Abbott Diabetes Care, Adaptyx Biosciences, Biolinq, Capillary Biomedical, Deep Valley Labs, Gluroo, PhysioLogic Devices, Portal Insulin, and Tidepool. He has served on the advisory boards for ProventionBio and Lilly. He receives research support from Insulet, Medtronic, and Tandem.
Databáze: MEDLINE