CGM Use in Adults With Type 2 Diabetes on Basal Insulin
Real-Time Glucose Monitoring Using FreeStyle Libre 3 in Adults With Type 2 Diabetes On Basal Insulin Plus SGLT2 Inhibitor and/or GLP-1
1 other identifier
interventional
470
1 country
25
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Jul 2023
Longer than P75 for not_applicable diabetes-mellitus-type-2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2023
CompletedFirst Posted
Study publicly available on registry
July 13, 2023
CompletedStudy Start
First participant enrolled
July 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2027
ExpectedFebruary 12, 2026
April 1, 2025
2.7 years
July 6, 2023
February 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
HbA1c
Difference between treatment groups in mean change from baseline in HbA1c.
16 weeks
Secondary Outcomes (5)
HbA1c
32 weeks
Time in range (TIR)
32 weeks
Time above range (TAR)
32 weeks
Time below range(TBR)
32 weeks
Frequency of hypoglycaemia events
32 weeks
Study Arms (2)
FreeStyle Libre system
ACTIVE COMPARATORFreeStyle Libre 3 continuous glucose monitoring system
Standard of care (control)
OTHERSelf monitoring of blood glucose
Interventions
Subjects will be randomised to use the FreeStyle Libre 3 system
Subjects will be randomised to continue with their current glucose monitoring system
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
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, DE22 3NE, 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, M13 9WU, 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
Related Publications (1)
Wilmot EG, Ajjan RA, Cheah YS, Choudhary P, Cranston I, Elliott RA, Evans M, Iqbal A, Kamaruddin S, Barnard-Kelly K, Lumb A, Min T, Moore P, Narendran P, Neupane S, Rayman G, Sathyapalan T, Thabit H, Yates T, Leelarathna L. Impact of real-time glucose monitoring using FreeStyle Libre 3 on glycaemia in type 2 diabetes managed with basal insulin plus SGLT2 inhibitor and/or GLP-1 agonist: the FreeDM2 randomised controlled trial protocol. BMJ Open. 2025 Apr 15;15(4):e090154. doi: 10.1136/bmjopen-2024-090154.
PMID: 40233956DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pamela Reid
Abbott Diabetes Care Ltd
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2023
First Posted
July 13, 2023
Study Start
July 14, 2023
Primary Completion
March 30, 2026
Study Completion (Estimated)
November 30, 2027
Last Updated
February 12, 2026
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- 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.
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.