Initiation of Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin, in Italy

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes Treated With Insulin
• Interventions: Device: FreeStyle Libre 2 Flash Glucose Monitoring System

• Registration Number: NCT06268808
• Lead Sponsor: Abbott Diabetes Care

Brief Summary

The goal of this clinical study is to determine the impact of starting the use of the FreeStyle Libre 2 glucose monitoring system, over a three month period, on HbA1c in adults with type 2 diabetes treated with a basal insulin regimen.

Detailed Description

This is a post-market, multi-centre, prospective, interventional single arm study in Italy.

Participants will use the FreeStyle Libre 2 Flash Glucose Monitoring System, according to the labelling, to monitor their glucose for approximately 3 months. Additional therapies may be introduced, if clinically indicated, based on review of the participant's clinical data and in line with national guidance.

HbA1c will be tested at the start and end of the study for primary endpoint analysis.

Study Timeline

• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Study First Posted: 2024-02-20
• Study Start: 2024-07-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Aged ≥18 to ≤ 75 years.
• Type 2 diabetes diagnosis ≥1 year prior to enrolment.
• Type 2 diabetes treated with a basal insulin injection regimen with or without other antihyperglycaemic therapy at enrolment.
• Current glucose lowering treatment regimen has been established for at least 3 months prior to enrolment.
• Screening HbA1c ≥59 mmol/mol to ≤108 mmol/mol (≥7.5% and ≤12.0%, inclusive), within the last 60 days.

Exclusion Criteria

• Participant is currently prescribed prandial or pre-mixed (biphasic) insulin at enrolment.
• Currently participating in another study that could affect glucose measurements or glucose management.
• Currently receiving dialysis treatment or receives dialysis during the study.
• A female participant who is pregnant.
• A breastfeeding female participant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	FreeStyle Libre 2 Flash Glucose Monitoring System	FreeStyle Libre 2 Flash Glucose Monitoring System

Primary Outcome Measures

Name	Time	Method
HbA1c	3 months	Change in HbA1c within group from baseline

Secondary Outcome Measures

Name	Time	Method
Frequency of hypoglycaemia events	3 months	CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose \<3.9mmol/L (\<70mg/dL)
Time below range (TBR)	3 months	Time spent below glucose target range (TBR) \<3.9 mmol/L and \<3.0 mmol/L (\<70 mg/dL and \<54 mg/dL).
Time in range (TIR)	3 months	Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL)
Time above range (TAR)	3 months	Time spent above glucose target range (TAR) \>10.0 mmol/L, \>13.9 mmol/L and \>16.7 mmol/L (\>180 mg/dL, \>250 mg/dL and \>300 mg/dL).

Trial Locations

Locations (6)

ASL Toscana Nord Ovest; 🇮🇹 Livorno, Italy

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari; 🇮🇹 Bari, Italy

Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O. Endocrinologia; 🇮🇹 Catania, Italy

Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O.C. Medicina Interna; 🇮🇹 Catania, Italy

Azienda Ospedaliero-Universitaria di Parma; 🇮🇹 Parma, Italy

La Sapienza Università di Roma, AOU Policlinico Umberto I; 🇮🇹 Rome, Italy