A prospective multi-centre, open-label, two arm, parallel design, superiority, pragmatic, randomised controlled trial, over an 8-month period. The purpose of this study is to determine whether continuous glucose monitoring using FreeStyle Libre 3 will improve HbA1c compared to SMBG over 16 weeks in adults with sub-optimally controlled (HbA1c 7.5-11%) Type 2 diabetes on basal therapy.

Following completion of the 8-month period for all participants, an optional non-interventional follow-up period will assess glycaemic control and treatment patterns over 24 months.

The study will assess change in HbA1c as the primary endpoint. Other endpoints related to glycaemic control are included in the analyses. The study is split into two phases each of four months duration: participant-driven (phase 1) and HCP/therapy-driven (phase 2). Participants will be randomised to either FreeStyle Libre 3 or to continuation with their current SMBG device.

Inclusion Criteria:

• Aged 18 years or over.
• Type 2 diabetes diagnosis for ≥1 year prior to enrolment.
• Type 2 diabetes treated with a basal insulin injection regimen and SGLT2 inhibitor and/or GLP-1.
• Screening HbA1c ≥59 mmol/mol to ≤97 mmol/mol (≥7.5% and ≤11.0%, inclusive).

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.
• A female participant who is pregnant.
• A breastfeeding female participant.
• Bariatric surgical procedure within the past 12 months or is planning/scheduled for bariatric surgery within the study duration.

Individual participant data that underlie the results reported in the primary study manuscript after deidentification (text, tables, figures and appendices) for the purposes of individual participant data meta-analysis.

Beginning 9 months and ending 3 years (36 months) following article publication

Researchers undertaking individual participant data meta-analysis who provide a methodologically sound proposal, approved by an independent review committee, and not overlapping with any planned secondary publications from the research team. Proposals should be directed to the corresponding author of the article who will discuss such requests with the study investigator team. To gain access, data requesters will need to sign a data access agreement. Data will be available for up to 3 years (36 months) following article publication.