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Diabetes Mellitus, Type 2NCT05944432

CGM Use in Adults With Type 2 Diabetes on Basal Insulin

A study testing FreeStyle Libre 3 Continuous Glucose Monitoring System. and Self monitoring of blood glucose in people with Diabetes Mellitus, Type 2, run by Abbott Diabetes Care at 25 sites in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
FreeStyle Libre 3 Continuous Glucose Monitoring System. and Self monitoring of blood glucose
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
469 participants
Where
25 sitesUnited Kingdom
Study dates
26 Jul 2023to 30 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

United Kingdom25 sites

  • Tameside General Hospital

    Ashton-under-Lyne

  • Royal United Hospital

    Bath

  • Queen Elizabeth Hospital

    Birmingham

  • Cambridge University Hospital (Addenbrookes)

    Cambridge

  • Darlington Memorial Hospital

    Darlington

  • Royal Derby Hospital

    Derby, DE22 3NE

  • Ninewells Hospital

    Dundee

  • Princess Alexandra Hospital

    Harlow

  • Northwick Park Hospital

    Harrow

  • Hull Royal Infirmary

    Hull

  • Ipswich Hospital

    Ipswich

  • St James University Hospital

    Leeds

  • Leicester General Hospital

    Leicester

  • King's College Hospital

    London

  • St Mary's Hospital

    London

  • Manchester Royal Infirmary

    Manchester, M13 9WU

  • Norfolk and Norwich University Hospital

    Norwich

  • Churchill Hospital

    Oxford

  • Derriford Hospital

    Plymouth

  • The Adam Practice

    Poole

  • Queen Alexandra Hospital

    Portsmouth

  • Northern General Hospital

    Sheffield

  • Moorgreen Hospital

    Southampton

  • Singleton Hospital

    Swansea

  • Wishaw Hospital

    Wishaw

Other trials in United Kingdom

About this study

Official title: Real-Time Glucose Monitoring Using FreeStyle Libre 3 in Adults With Type 2 Diabetes On Basal Insulin Plus SGLT2 Inhibitor and/or GLP-1

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.

Read the detailed description

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.

Being tested
FreeStyle Libre 3 Continuous Glucose Monitoring System., Self monitoring of blood glucose
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FreeStyle Libre 3 Continuous Glucose Monitoring System.Device

    Subjects will be randomised to use the FreeStyle Libre 3 system

  • Self monitoring of blood glucoseDevice

    Subjects will be randomised to continue with their current glucose monitoring system

Study groups in NCT05944432
Study groupRoleWhat they receive
FreeStyle Libre systemActive comparatorFreeStyle Libre 3 continuous glucose monitoring system
Receives: Device: FreeStyle Libre 3 Continuous Glucose Monitoring System.
Standard of care (control)OtherSelf monitoring of blood glucose
Receives: Device: Self monitoring of blood glucose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c

    Difference between treatment groups in mean change from baseline in HbA1c.

    Measured: 16 weeks

Secondary outcomes (5)

  1. HbA1c

    Difference between treatment groups in mean change from baseline in HbA1c

    Measured: 32 weeks

  2. Time in range (TIR)

    Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL).

    Measured: 32 weeks

  3. 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).

    Measured: 32 weeks

  4. 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).

    Measured: 32 weeks

  5. Frequency of hypoglycaemia events

    CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose <3.9 mmol/L (<70 mg/dL).

    Measured: 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2023
  2. Study start26 Jul 2023
  3. Primary completion19 Feb 2026
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
469 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05944432
Sponsor's protocol ID
ADC-UK-PMS-22057
Status last verified
Oct 2026
First submitted
6 Jul 2023
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Wilmot EG, Moore P, Sathyapalan T, Choudhary P, Lim JZM, Neupane S, Crabtree TSJ, Iqbal A, Evans ML, Rayman G, Price HC, Ajjan RA, Cheah YS, Lumb A, Mostafa S, Malik I, Cranston I, Min T, Jude EB, Seechurn S, McLaren J, Barnard-Kelly K, Yates T, Elliott RA, Leelarathna L; FreeDM2 Study Group. Continuous glucose monitoring versus self-monitoring of blood glucose in individuals with type 2 diabetes: a randomised, multicentre, open-label, superiority trial. Lancet Diabetes Endocrinol. 2026 Jun;14(6):463-474. doi: 10.1016/S2213-8587(26)00076-8. Epub 2026 Apr 23.

    PubMed 42035781

  • 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.

    PubMed 40233956

Questions about this trial

What is this clinical trial studying?

A study testing FreeStyle Libre 3 Continuous Glucose Monitoring System. and Self monitoring of blood glucose in people with Diabetes Mellitus, Type 2, run by Abbott Diabetes Care at 25 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05944432, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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