CGM Use in Adults With Type 2 Diabetes on Basal Insulin

Last updated: April 4, 2025
Sponsor: Abbott Diabetes Care
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes Mellitus, Type 2

Treatment

Self monitoring of blood glucose

FreeStyle Libre 3 Continuous Glucose Monitoring System.

Clinical Study ID

NCT05944432
ADC-UK-PMS-22057
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 inhibitorand/or GLP-1.

  • Screening HbA1c ≥59 mmol/mol to ≤97 mmol/mol (≥7.5% and ≤11.0%, inclusive).

Exclusion

Exclusion Criteria:

  • Participant is currently prescribed prandial or pre-mixed (biphasic) insulin atenrolment.

  • Currently participating in another study that could affect glucose measurements orglucose management.

  • A female participant who is pregnant.

  • A breastfeeding female participant.

  • Bariatric surgical procedure within the past 12 months or is planning/scheduled forbariatric surgery within the study duration.

Study Design

Total Participants: 470
Treatment Group(s): 2
Primary Treatment: Self monitoring of blood glucose
Phase:
Study Start date:
July 14, 2023
Estimated Completion Date:
November 30, 2025

Study 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.

Connect with a study center

  • Tameside General Hospital

    Ashton-under-Lyne,
    United Kingdom

    Site Not Available

  • Royal United Hospital

    Bath,
    United Kingdom

    Site Not Available

  • Queen Elizabeth Hospital

    Birmingham,
    United Kingdom

    Site Not Available

  • Brighton General Hospital

    Brighton,
    United Kingdom

    Site Not Available

  • Cambridge University Hospital (Addenbrookes)

    Cambridge,
    United Kingdom

    Site Not Available

  • Darlington Memorial Hospital

    Darlington,
    United Kingdom

    Site Not Available

  • Royal Derby Hospital

    Derby, DE22 3NE
    United Kingdom

    Site Not Available

  • Ninewells Hospital

    Dundee,
    United Kingdom

    Site Not Available

  • Princess Alexandra Hospital

    Harlow,
    United Kingdom

    Site Not Available

  • Northwick Park Hospital

    Harrow,
    United Kingdom

    Site Not Available

  • Hull Royal Infirmary

    Hull,
    United Kingdom

    Site Not Available

  • Ipswich Hospital

    Ipswich,
    United Kingdom

    Site Not Available

  • St James University Hospital

    Leeds,
    United Kingdom

    Site Not Available

  • Leicester General Hospital

    Leicester,
    United Kingdom

    Site Not Available

  • Hammersmith Hospital

    London,
    United Kingdom

    Active - Recruiting

  • King's College Hospital

    London,
    United Kingdom

    Site Not Available

  • St Mary's Hospital

    London,
    United Kingdom

    Site Not Available

  • Manchester Royal Infirmary

    Manchester, M13 9WU
    United Kingdom

    Site Not Available

  • Norfolk and Norwich University Hospital

    Norwich,
    United Kingdom

    Site Not Available

  • Churchill Hospital

    Oxford,
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth,
    United Kingdom

    Site Not Available

  • The Adam Practice

    Poole,
    United Kingdom

    Site Not Available

  • Queen Alexandra Hospital

    Portsmouth,
    United Kingdom

    Site Not Available

  • Northern General Hospital

    Sheffield,
    United Kingdom

    Site Not Available

  • Moorgreen Hospital

    Southampton,
    United Kingdom

    Site Not Available

  • Singleton Hospital

    Swansea,
    United Kingdom

    Site Not Available

  • Wishaw Hospital

    Wishaw,
    United Kingdom

    Site Not Available

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