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Clinical Trials in the UK / NCT05944432
Active, not recruiting Not applicable

CGM Use in Adults With Type 2 Diabetes on Basal Insulin

NCT05944432 · tracked via the Priya Life Science UK tracker
Sponsor
Abbott Diabetes Care
Phase
Not applicable
Started
2023-07-14
Last updated
2026-08-21

Condition(s) studied

Diabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

FreeStyle Libre 3 Continuous Glucose Monitoring System.Self monitoring of blood glucose

FreeStyle Libre 3 Continuous Glucose Monitoring System.: Subjects will be randomised to use the FreeStyle Libre 3 system

Self monitoring of blood glucose: Subjects will be randomised to continue with their current glucose monitoring system

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
Tameside General Hospital Ashton-under-Lyne United Kingdom
Royal United Hospital Bath United Kingdom
Queen Elizabeth Hospital Birmingham United Kingdom
Cambridge University Hospital (Addenbrookes) Cambridge United Kingdom
Darlington Memorial Hospital Darlington United Kingdom
Royal Derby Hospital Derby United Kingdom
Ninewells Hospital Dundee United Kingdom
Princess Alexandra Hospital Harlow United Kingdom
Northwick Park Hospital Harrow United Kingdom
Hull Royal Infirmary Hull United Kingdom
Ipswich Hospital Ipswich United Kingdom
St James University Hospital Leeds United Kingdom
Leicester General Hospital Leicester United Kingdom
King's College Hospital London United Kingdom
St Mary's Hospital London United Kingdom
Manchester Royal Infirmary Manchester United Kingdom
Norfolk and Norwich University Hospital Norwich United Kingdom
Churchill Hospital Oxford United Kingdom
Derriford Hospital Plymouth United Kingdom
The Adam Practice Poole United Kingdom
Queen Alexandra Hospital Portsmouth United Kingdom
Northern General Hospital Sheffield United Kingdom
Moorgreen Hospital Southampton United Kingdom
Singleton Hospital Swansea United Kingdom
Wishaw Hospital Wishaw United Kingdom

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05944432 on ClinicalTrials.gov ↗ ← All trials in the UK