Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Other | FreeStyle Libre 2 Flash Glucose Monitoring System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Change in HbA1c within group from baseline | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time in range (TIR) | Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL) | 3 months |
| Time above range (TAR) | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francesco Giorgino, MD, PhD | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari | Bari | Italy | ||||
| ASL Toscana Nordovest |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 3 months |
| Time below range (TBR) | Time spent below glucose target range (TBR) <3.9 mmol/L and <3.0 mmol/L (<70 mg/dL and <54 mg/dL). | 3 months |
| Frequency of hypoglycaemia events | CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose <3.9mmol/L (<70mg/dL) | 3 months |
| Carrara |
| 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 "Renato Dulbecco" di Catanzaro | Catanzaro | Italy |
| ASL Toscana Nord Ovest | Livorno | Italy |
| Azienda Ospedaliero-Universitaria di Parma | Parma | Italy |
| La Sapienza Università di Roma, AOU Policlinico Umberto I | Rome | Italy |