Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334484
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2024-03-21
Brief Title:
Effect of Advanced Hybrid Closed Loop System on Adjunctive Continuous Glucose Monitoring Metrics
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Effect of Advanced Hybrid Closed Loop System on Adjunctive Continuous Glucose Monitoring Metrics Two-years Observational Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TiTR_GR1DM
Brief 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 34 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None