Using FreeStyle Libre 2 for glucose monitoring in adults with type 2 diabetes in Italy

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

This study is testing if using the FreeStyle Libre 2 glucose monitor can help adults with type 2 diabetes who use basal insulin lower their HbA1c levels over three months.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 82 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Abbott Diabetes Care (industry)
• Locations: 6 sites (Bari and 5 other locations)
• Trial ID: NCT06268808 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the effects of the FreeStyle Libre 2 glucose monitoring system on HbA1c levels in adults with type 2 diabetes who are treated with basal insulin. It is a multi-centre, prospective, interventional study conducted in Italy, where participants will use the glucose monitoring system for approximately three months. The study will assess changes in HbA1c from baseline to the end of the monitoring period, with the possibility of adjusting other therapies based on clinical data. The primary endpoint will be the change in HbA1c levels measured at the start and end of the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 years with a diagnosis of type 2 diabetes treated with basal insulin for at least three months.

Not a fit: Patients currently using prandial or pre-mixed insulin, those on dialysis, or pregnant or breastfeeding women may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help improve glycemic control in adults with type 2 diabetes, potentially leading to better health outcomes.

How similar studies have performed: Other studies have shown positive outcomes with continuous glucose monitoring in diabetes management, suggesting this approach may be effective.

Eligibility criteria

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.

Where this trial is running

Bari and 5 other locations

• Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari — Bari, Italy (RECRUITING)
• Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O. Endocrinologia — Catania, Italy (RECRUITING)
• Università degli Studi di Catania, Ospedale Garibaldi-Nesima, U.O.C. Medicina Interna — Catania, Italy (RECRUITING)
• ASL Toscana Nord Ovest — Livorno, Italy (RECRUITING)
• Azienda Ospedaliero-Universitaria di Parma — Parma, Italy (RECRUITING)
• La Sapienza Università di Roma, AOU Policlinico Umberto I — Rome, Italy (RECRUITING)

Study contacts

• Principal investigator: Francesco Giorgino, MD, PhD — Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Study coordinator: Pamela Reid, PhD

Conditions: Type 2 Diabetes Treated With Insulin