CGM Use in Adults With Type 2 Diabetes on Basal Insulin

NCT ID: NCT05944432

Last Updated: 2025-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

470 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-14

Study Completion Date

2025-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FreeStyle Libre system

FreeStyle Libre 3 continuous glucose monitoring system

Group Type ACTIVE_COMPARATOR

FreeStyle Libre 3 Continuous Glucose Monitoring System.

Intervention Type DEVICE

Subjects will be randomised to use the FreeStyle Libre 3 system

Standard of care (control)

Self monitoring of blood glucose

Group Type OTHER

Self monitoring of blood glucose

Intervention Type DEVICE

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

Interventions

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FreeStyle Libre 3 Continuous Glucose Monitoring System.

Subjects will be randomised to use the FreeStyle Libre 3 system

Intervention Type DEVICE

Self monitoring of blood glucose

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Diabetes Care

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pamela Reid

Role: STUDY_DIRECTOR

Abbott Diabetes Care Ltd

Locations

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Tameside General Hospital

Ashton-under-Lyne, , United Kingdom

Site Status

Royal United Hospital

Bath, , United Kingdom

Site Status

Queen Elizabeth Hospital

Birmingham, , United Kingdom

Site Status

Cambridge University Hospital (Addenbrookes)

Cambridge, , United Kingdom

Site Status

Darlington Memorial Hospital

Darlington, , United Kingdom

Site Status

Royal Derby Hospital

Derby, , United Kingdom

Site Status

Ninewells Hospital

Dundee, , United Kingdom

Site Status

Princess Alexandra Hospital

Harlow, , United Kingdom

Site Status

Northwick Park Hospital

Harrow, , United Kingdom

Site Status

Hull Royal Infirmary

Hull, , United Kingdom

Site Status

Ipswich Hospital

Ipswich, , United Kingdom

Site Status

St James University Hospital

Leeds, , United Kingdom

Site Status

Leicester General Hospital

Leicester, , United Kingdom

Site Status

King's College Hospital

London, , United Kingdom

Site Status

St Mary's Hospital

London, , United Kingdom

Site Status

Manchester Royal Infirmary

Manchester, , United Kingdom

Site Status

Norfolk and Norwich University Hospital

Norwich, , United Kingdom

Site Status

Churchill Hospital

Oxford, , United Kingdom

Site Status

Derriford Hospital

Plymouth, , United Kingdom

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The Adam Practice

Poole, , United Kingdom

Site Status

Queen Alexandra Hospital

Portsmouth, , United Kingdom

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Northern General Hospital

Sheffield, , United Kingdom

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Moorgreen Hospital

Southampton, , United Kingdom

Site Status

Singleton Hospital

Swansea, , United Kingdom

Site Status

Wishaw Hospital

Wishaw, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 40233956 (View on PubMed)

Other Identifiers

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ADC-UK-PMS-22057

Identifier Type: -

Identifier Source: org_study_id

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