CGM Use in Adults With Type 2 Diabetes on Basal Insulin

Not Applicable

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT05944432
• Lead Sponsor: Abbott Diabetes Care

Brief 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.

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 Timeline

• Study First Submitted: 2023-07-06
• Study First Submitted QC: 2023-07-12
• Study First Posted: 2023-07-13
• Study Start: 2023-07-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-08-31
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 470

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
HbA1c	16 weeks	Difference between treatment groups in mean change from baseline in HbA1c.

Secondary Outcome Measures

Name	Time	Method
HbA1c	32 weeks	Difference between treatment groups in mean change from baseline in HbA1c
Time in range (TIR)	32 weeks	Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL).
Time above range (TAR)	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).
Time below range(TBR)	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).
Frequency of hypoglycaemia events	32 weeks	CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose \<3.9 mmol/L (\<70 mg/dL).

Trial Locations

Locations (25)

Tameside General Hospital; 🇬🇧 Ashton-under-Lyne, United Kingdom

Royal United Hospital; 🇬🇧 Bath, United Kingdom

Queen Elizabeth Hospital; 🇬🇧 Birmingham, United Kingdom

Cambridge University Hospital (Addenbrookes); 🇬🇧 Cambridge, United Kingdom

Darlington Memorial Hospital; 🇬🇧 Darlington, United Kingdom

Royal Derby Hospital; 🇬🇧 Derby, United Kingdom

Ninewells Hospital; 🇬🇧 Dundee, United Kingdom

Princess Alexandra Hospital; 🇬🇧 Harlow, United Kingdom

Northwick Park Hospital; 🇬🇧 Harrow, United Kingdom

Hull Royal Infirmary; 🇬🇧 Hull, United Kingdom

Scroll for more (15 remaining)