An interventional study of FreeStyle Libre 3 Continuous Glucose Monitoring System. and Self monitoring of blood glucose in Diabetes Mellitus, Type 2, sponsored by Abbott Diabetes Care. Active, not recruiting at 25 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Abbott Diabetes Care (part of Abbott) · Not applicable, Interventional, and Treatment
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's enrollment of 469 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Abbott Diabetes Care is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FreeStyle Libre 3 continuous glucose monitoring system
Device: FreeStyle Libre 3 Continuous Glucose Monitoring System.
Self monitoring of blood glucose
Device: Self monitoring of blood glucose
Subjects will be randomised to use the FreeStyle Libre 3 system
Subjects will be randomised to continue with their current glucose monitoring system
HbA1c
Difference between treatment groups in mean change from baseline in HbA1c.
Time frame: 16 weeks
HbA1c
Difference between treatment groups in mean change from baseline in HbA1c
Time frame: 32 weeks
Time in range (TIR)
Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL).
Time frame: 32 weeks
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).
Time frame: 32 weeks
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).
Time frame: 32 weeks
Frequency of hypoglycaemia events
CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose \<3.9 mmol/L (\<70 mg/dL).
Time frame: 32 weeks
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form
Time frame: Beginning 9 months and ending 3 years (36 months) following article publication
Access criteria: 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.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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