Sponsor decision

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 Finland.

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.

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.