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

NCT ID: NCT06268808

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-19

Study Completion Date

2025-09-24

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Treated With Insulin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention

FreeStyle Libre 2 Flash Glucose Monitoring System

Group Type OTHER

FreeStyle Libre 2 Flash Glucose Monitoring System

Intervention Type DEVICE

Glucose sensors to be worn continuously for 3 months with data used to monitor and manage diabetes treatment and to inform lifestyle choices (diet and exercise)

Interventions

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FreeStyle Libre 2 Flash Glucose Monitoring System

Glucose sensors to be worn continuously for 3 months with data used to monitor and manage diabetes treatment and to inform lifestyle choices (diet and exercise)

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Diabetes Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Francesco Giorgino, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Locations

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Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, , Italy

Site Status

ASL Toscana Nordovest

Carrara, , Italy

Site Status

Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O. Endocrinologia

Catania, , Italy

Site Status

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

Catania, , Italy

Site Status

Azienda Ospedaliero- Universitaria "Renato Dulbecco" di Catanzaro

Catanzaro, , Italy

Site Status

ASL Toscana Nord Ovest

Livorno, , Italy

Site Status

Azienda Ospedaliero-Universitaria di Parma

Parma, , Italy

Site Status

La Sapienza Università di Roma, AOU Policlinico Umberto I

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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ADC-UK-PMS-23058

Identifier Type: -

Identifier Source: org_study_id