CGM Use in Adults With Type 2 Diabetes on Basal Insulin

March 20, 2024 updated by: Abbott Diabetes Care

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 or 32 weeks in adults with sub-optimally controlled (HbA1c 7.5-11%) Type 2 diabetes on basal therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

430

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom
        • Recruiting
        • Queen Elizabeth Hospital
        • Contact:
          • Parth Narandran
      • Cambridge, United Kingdom
        • Recruiting
        • Cambridge University Hospital (Addenbrookes)
        • Contact:
          • Mark Evans
      • Darlington, United Kingdom
        • Recruiting
        • Darlington Memorial Hospital
        • Contact:
          • Shafie Kamaruddin
      • Derby, United Kingdom, DE22 3NE
        • Recruiting
        • Royal Derby Hospital
        • Contact:
      • Hull, United Kingdom
        • Recruiting
        • Hull Royal Infirmary
        • Contact:
          • Thozhukat Sathyapalan
      • Ipswich, United Kingdom
        • Recruiting
        • Ipswich Hospital
        • Contact:
          • Gerry Rayman
      • Leeds, United Kingdom
        • Recruiting
        • St James University Hospital
        • Contact:
          • Ramzi Ajjan
      • Leicester, United Kingdom
        • Recruiting
        • Leicester General Hospital
        • Contact:
          • Pratik Choudhary
      • London, United Kingdom
        • Recruiting
        • King's College Hospital
        • Contact:
          • Yee Cheah
      • London, United Kingdom
      • Manchester, United Kingdom, M13 9WU
      • Norwich, United Kingdom
        • Recruiting
        • Norfolk and Norwich University Hospital
        • Contact:
          • Sankalpa Neupane
      • Oxford, United Kingdom
        • Recruiting
        • Churchill Hospital
        • Contact:
          • Alistair Lumb
      • Poole, United Kingdom
        • Recruiting
        • The Adam Practice
        • Contact:
          • Patrick Moore
      • Portsmouth, United Kingdom
        • Recruiting
        • Queen Alexandra Hospital
        • Contact:
          • Iain Cranston
      • Sheffield, United Kingdom
        • Recruiting
        • Northern General Hospital
        • Contact:
          • Ahmed Iqbal
      • Swansea, United Kingdom
        • Recruiting
        • Singleton Hospital
        • Contact:
          • Thinzar MIn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FreeStyle Libre system
FreeStyle Libre 3 continuous glucose monitoring system
Device: FreeStyle Libre 3 Continuous Glucose Monitoring System.
Subjects will be randomised to use the FreeStyle Libre 3 system
Other: Standard of care (control)
Self monitoring of blood glucose
Device: Self monitoring of blood glucose
Subjects will be randomised to continue with their current glucose monitoring system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: 16 weeks
Difference between treatment groups in mean change from baseline in HbA1c.
16 weeks
HbA1c
Time Frame: 32 weeks
Difference between treatment groups in mean change from baseline in HbA1c
32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in range (TIR)
Time Frame: 32 weeks
Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL).
32 weeks
Time above range (TAR)
Time Frame: 32 weeks
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).
32 weeks
Time below range(TBR)
Time Frame: 32 weeks
Time spent below glucose target range (TBR) <3.9 mmol/L and <3.0 mmol/L (<70 mg/dL and <54 mg/dL).
32 weeks
Frequency of hypoglycaemia events
Time Frame: 32 weeks
CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose <3.9 mmol/L (<70 mg/dL).
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Diabetes Care

Investigators

  • Study Director: Pamela Reid, Abbott Diabetes Care Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 13, 2023

Study Record Updates

Last Update Posted (Actual)

March 21, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADC-UK-PMS-22057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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