NCT06147583 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Facchinetti A, Del Favero S, Sparacino G, Cobelli C
An online failure detection method of the glucose sensor-insulin pump system: improved overnight safety of type-1 diabetic subjects. IEEE Trans Biomed Eng. 2013 Feb;60(2):406-16. doi: 10.1109/TBME.2012.2227256. Epub 2012 Nov 15.
Meneghetti L, Dassau E, Doyle FJ 3rd, Del Favero S
Machine Learning-Based Anomaly Detection Algorithms to Alert Patients Using Sensor Augmented Pump of Infusion Site Failures. J Diabetes Sci Technol. 2022 May;16(3):641-648. doi: 10.1177/1932296821997854. Epub 2021 Mar 9.
Meneghetti L, Facchinetti A, Favero SD
Model-Based Detection and Classification of Insulin Pump Faults and Missed Meal Announcements in Artificial Pancreas Systems for Type 1 Diabetes Therapy. IEEE Trans Biomed Eng. 2021 Jan;68(1):170-180. doi: 10.1109/TBME.2020.3004270. Epub 2020 Dec 21.
Meneghetti L, Susto GA, Del Favero S
Detection of Insulin Pump Malfunctioning to Improve Safety in Artificial Pancreas Using Unsupervised Algorithms. J Diabetes Sci Technol. 2019 Nov;13(6):1065-1076. doi: 10.1177/1932296819881452. Epub 2019 Oct 14.

Pilot Study for the Evaluation of Algorithms for the Detection of Subcutaneous Insulin Pump Malfunctions in Subjects With Type 1 Diabetes

Clinical trial NCT06147583 - References