Effect of Advanced Hybrid Closed Loop System on Adjunctive Continuous Glucose Monitoring Metrics - Trial NCT06334484
Access comprehensive clinical trial information for NCT06334484 through Pure Global AI's free database. This phase not specified trial is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS and is currently Not yet recruiting. The study focuses on Diabetes Mellitus, Type 1. Target enrollment is 100 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.
Study Focus
Sponsor & Location
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Timeline & Enrollment
N/A
Mar 26, 2024
Mar 26, 2026
Primary Outcome
change in time spent in tighter glucose range after 24 months of hybrid closed loop system
Summary
Type 1 diabetes mellitus (T1DM) is an autoimmune disease characterized by pancreatic beta
 cells destruction, resulting in insulin secretion deficit (1). Insulin therapy is essential
 in the therapeutical management of subjects with T1DM (1). The Diabetes Complications and
 Control Trial (DCCT) has showed that intensive insulin treatment was associated with a
 reduction in the onset of complications related to diabetes. In recent years, treatment of
 T1DM evolved rapidly because of the significant improvements in the use of technology (2).
 With the spread of continuous glucose monitoring (CGM) systems, standardized metrics,
 summarizing time spent within optimal glucose range (time in range - TIR), time below target
 glucose range (TBR) and time above target glucose range (TAR), have become commonly used
 metrics in clinical practice (3,4). Furthermore, glucose management indicator (GMI) estimates
 glycated haemoglobin from the average glucose level of CGM readings for 14 days and
 coefficient of variation (CV) evaluates the amplitude of glucose excursions.
 
 Advanced hybrid closed loop (AHCL) systems combine insulin pump infusion and real time CGM
 (rtCGM) data through an algorithm: they suspend insulin infusion if hypoglycaemia is expected
 and can administer automatic corrective boluses in case of hyperglycaemia (6). Different
 algorithms, as Model Predictive Control (MPC) or Proportional-Integral-Derivative (PID), are
 used by different systems available on the market and are currently used in clinical
 practice. Overall, AHCL are associated with improvement of glycated hemoglobin (HbA1c) and
 TIR opening to the possibility to gain even tighter glycemic control.
 
 The primary objective is therefore to evaluate the glycemic improvement expressed through
 adjunctive CGM metrics in subjects with T1DM 24 months after starting AHCL therapy
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06334484
Device Trial