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Assessing Detection Algorithms for Insulin Pump Malfunctions in Type 1 Diabetes

NCT06147583 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-12-14

No results posted yet for this study

Summary

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:

* free-living artificial pancreas data collection,
* in-patient induction of hyperglycemia (mimicking an insulin pump malfunction),
* retrospective analysis of the collected data to evaluate the effectiveness of the proposed algorithms in detecting insulin suspension.

Conditions

  • Diabetes Mellitus, Type I

Interventions

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.

Sponsors & Collaborators

  • Azienda Ospedaliera di Padova

    collaborator OTHER

  • University of Padova

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2024-02-29
Completion
2024-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06147583 on ClinicalTrials.gov