An interventional study of Simulation of an insulin pump failure in Diabetes Mellitus, Type I, sponsored by University of Padova. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-12-14.
Sponsored by University of Padova · Not applicable, Interventional, and Supportive care
The goal of this clinical trial is to test the effectiveness of fault-detection algorithms in detecting malfunctioning of the insulin infusion system in an artificial pancreas (also known as Automated Insulin Delivery system) for type 1 diabetes.
The main questions it aims to answer is:
"Are the proposed algorithms effective in detecting insulin suspension?" Effectiveness accounts for both high sensitivity (i.e. the fraction of suspension correctly detected) and low false alarm rate.
The study has three phases:
In individuals with type 1 diabetes, adjusting insulin doses to accommodate the ever-changing conditions of daily life is crucial for achieving satisfactory metabolic control. To address this challenge, researchers have developed an Automated Insulin Delivery (AID) system, commonly known as an artificial pancreas. This system comprises of an insulin pump, a continuous glucose monitoring (CGM) sensor, and a sophisticated control algorithm. The algorithm uses CGM data to calculate the insulin dose required to maintain good glycemic control, and it automatically commands the insulin infusion.
However, artificial pancreas systems can experience malfunctions, some of which are highly risky. The most dangerous malfunctions include insulin pump failures and infusion set occlusions, which lead to prolonged interruptions in insulin delivery. This exposes the patient to the risk of hyperglycemia and, even more dangerously, ketoacidosis, a severe complication that can result in hospitalization and, in severe cases, death. Unfortunately, patients do not always notice these issues in a timely manner.
This study aims to test new algorithms for detecting pump/infusion set malfunctions that result in reduced or interrupted insulin delivery. The study consists of three phases:
The uniqueness of this dataset lies in the controlled induction of malfunction, achieved by disconnecting the insulin pump and monitoring the resulting hyperglycemic episode. The presence of malfunctions in this data is certain and precisely characterized in terms of the start time and duration. The dataset resulting from this experimentation will be a valuable tool for the scientific community, enabling the retrospective testing of fault detection algorithms.
3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →University of Padova is the lead sponsor of 214 studies on the registry; 41 are open to participants now.
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Exclusion Criteria:
Collection of patients data during outpatient use of AID (automated insulin delivery); Inpatient simulation of insulin pump faults by suspension of insulin administration.
Other: Simulation of an insulin pump failure
The intervention will consist in simulating an insulin pump failure by suspending insulin infusion and monitoring the consequent hyperglycemia.
Sensitivity
Fraction of correctly detected insulin suspension in the population
Time frame: During the intervention (during the inpatient insulin suspension to simulate a pump fault)
False positive per day
Number of false alarms (normalized by the number of days of monitoring)
Time frame: Baseline pre-intervention (during the outpatient data collection)
Plan to share: No
Start is estimated for Dec 2023; primary completion for Feb 2024, 2 months later.
Of 821 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 37. This study's planned 2 months is below that.
Counting every sponsor, half of 921 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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