In Silico Evaluation of the Medtronic 780G System While Using the GS3 and Its Calibration-Free Successor, the G4S Sensor

• Published in: Annals of biomedical engineering Vol. 51; no. 1; pp. 211 - 224
• Main Authors: Grosman, Benyamin, Parikh, Neha, Roy, Anirban, Lintereur, Louis, Vigersky, Robert, Cohen, Ohad, Rhinehart, Andrew
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.01.2023; Springer Nature B.V
• Subjects: Biochemistry; Biological and Medical Physics; Biomedical and Life Sciences; Biomedical Engineering and Bioengineering; Biomedicine; Biophysics; Blood Glucose; Calibration; Classical Mechanics; Clinical outcomes; Closed loops; Diabetes; Diabetes mellitus (insulin dependent); Diabetes Mellitus, Type 1; Glucose; Humans; Hypoglycemic Agents - therapeutic use; Insulin; Pharmacodynamics; Pharmacokinetics; Pharmacology; S.I. : Modeling for Advancing Regulatory Science; Sensors; Simulation; Switching; Artificial pancreas; Insulin pump therapy; Diabetes; Virtual patients
• ISSN: 0090-6964; 1573-9686; 1573-9686
• DOI: 10.1007/s10439-022-03079-9

In silico simulation studies using 5807 virtual patients with insulin dependent diabetes have been conducted to estimate the risk and efficacy with the closed-loop 780G pump when switching between Medtronic Guardian Sensor 3 (GS3) and Medtronic Guardian 4 Sensor (G4S), next generation calibration free glucose sensor. To demonstrate by utilizing a case study that captures the merits of in silico studies with single hormone insulin dependent virtual patients that include variability in pharmacokinetics/pharmacodynamics, age, gender, insulin sensitivity and BMIs. Also, to show that in silico studies can uniquely isolate the effect of a single variable on clinical outcomes. Simulation studies results were compared to clinical and commercial data and were separated by age groups and pump settings. The commercial data, the clinical study data and the simulation studies predicted that switching between GS3 to G4S will introduce a change in glucose average, percentage time between 70 and 180 mg/dL, and percentage time below 70 mg/dL of: 5.2, 3.4, and 3.1 mg/dL, − 1.1, 0.2, and − 1.1%, and − 0.6, − 1.0, and − 0.3%, respectively. We demonstrated that our simulation studies were able to predict the difference in glycemic outcomes when switching between different sensors in real world setting, better than a small clinical controlled study. As predicted, switching between GS3 and G4S sensors with the 780G system does not introduce clinical risk and maintain the clinical outcomes of the sensor. We demonstrated the ability of insulin dependent diabetes virtual patients to predict clinical outcomes and to augment or even replace some small clinical studies.