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

NCT06268808 | Completed

• 1 other identifier: ADC-UK-PMS-23058
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 8

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.

Conditions

Type 2 Diabetes Treated With Insulin

Outcome Measures

Primary Outcomes (1)

• HbA1c

  Change in HbA1c within group from baseline

  3 months

Secondary Outcomes (4)

• Time in range (TIR)

  3 months

• Time above range (TAR)

  3 months

• Time below range (TBR)

  3 months

• Frequency of hypoglycaemia events

  3 months

Study Arms (1)

Intervention

OTHER

FreeStyle Libre 2 Flash Glucose Monitoring System

Device: FreeStyle Libre 2 Flash Glucose Monitoring System

Interventions

FreeStyle Libre 2 Flash Glucose Monitoring System 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)

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Diabetes Care: lead

Study Sites (8)

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, Italy

Location

ASL Toscana Nordovest

Carrara, Italy

Location

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

Catania, Italy

Location

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

Catania, Italy

Location

Azienda Ospedaliero- Universitaria "Renato Dulbecco" di Catanzaro

Catanzaro, Italy

Location

ASL Toscana Nord Ovest

Livorno, Italy

Location

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

Location

La Sapienza Università di Roma, AOU Policlinico Umberto I

Rome, Italy

Location

Study Officials

• Francesco Giorgino, MD, PhD

  Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: July 19, 2024
• Primary Completion: September 24, 2025
• Study Completion: September 24, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (8)