CGM Use in Adults With Type 2 Diabetes on Basal Insulin

Abbott

Status: Enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: FreeStyle Libre 3 Continuous Glucose Monitoring System.; Device: Self monitoring of blood glucose

Study type: Interventional

Funder types: Industry

Identifiers

NCT05944432

ADC-UK-PMS-22057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 430 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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430 participants in 2 patient groups

FreeStyle Libre system

Active Comparator group

Description:

FreeStyle Libre 3 continuous glucose monitoring system

Treatment:

Device: FreeStyle Libre 3 Continuous Glucose Monitoring System.

Standard of care (control)

Other group

Description:

Self monitoring of blood glucose

Treatment:

Device: Self monitoring of blood glucose