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OpenTrials
Active, Not Recruiting

NCT Number: NCT05944432

CGM Use in Adults With Type 2 Diabetes on Basal Insulin

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tameside General Hospital, Ashton-under-Lyne, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FreeStyle Libre 3 Continuous Glucose Monitoring System.

Device

Subjects will be randomised to use the FreeStyle Libre 3 system

Self monitoring of blood glucose

Device

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

Primary outcomes

  1. HbA1c

    Time frame: 16 weeks

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

Secondary outcomes

  1. HbA1c

    Time frame: 32 weeks

    Difference between treatment groups in mean change from baseline in HbA1c

  2. 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).

  3. 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).

  4. 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).

  5. 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).

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jul 13, 2023
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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