CGM Use in Adults With Type 2 Diabetes on Basal Insulin

N/AActive Not RecruitingNCT05944432

Abbott Diabetes Care470 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

470

Conditions

Diabetes Mellitus, Type 2

Interventions

FreeStyle Libre 3 Continuous Glucose Monitoring System.DEVICE

Subjects will be randomised to use the FreeStyle Libre 3 system

Self monitoring of blood glucoseDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (25)

Tameside General Hospital

Ashton-under-Lyne, United Kingdom

Outcomes

Primary Outcomes

HbA1c

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

Time frame: 16 weeks

Secondary Outcomes

HbA1c

Difference between treatment groups in mean change from baseline in HbA1c

Time frame: 32 weeks

Time in range (TIR)

Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL).

Time frame: 32 weeks

Time above range (TAR)

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).

Time frame: 32 weeks

Time below range(TBR)

Time spent below glucose target range (TBR) \<3.9 mmol/L and \<3.0 mmol/L (\<70 mg/dL and \<54 mg/dL).

Time frame: 32 weeks

Frequency of hypoglycaemia events

CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose \<3.9 mmol/L (\<70 mg/dL).

Time frame: 32 weeks

Data from ClinicalTrials.gov

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