Clinical trial NCT05944432: CGM Use in Adults With Type 2 Diabetes on Basal Insulin
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2023-07-13
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: 16 weeks
Secondary outcomes:
measure: HbA1c
timeFrame: 32 weeks
measure: Time in range (TIR)
timeFrame: 32 weeks
measure: Time above range (TAR)
timeFrame: 32 weeks
measure: Time below range(TBR)
timeFrame: 32 weeks
measure: Frequency of hypoglycaemia events
timeFrame: 32 weeks
Other outcomes:
Locations:
city: Ashton-under-Lyne
country: United Kingdom
facility: Tameside General Hospital
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital (Addenbrookes)
city: Darlington
country: United Kingdom
facility: Darlington Memorial Hospital
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Harlow
country: United Kingdom
facility: Princess Alexandra Hospital
city: Harrow
country: United Kingdom
facility: Northwick Park Hospital
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Ipswich
country: United Kingdom
facility: Ipswich Hospital
city: Leeds
country: United Kingdom
facility: St James University Hospital
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: St Mary's Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Poole
country: United Kingdom
facility: The Adam Practice
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Southampton
country: United Kingdom
facility: Moorgreen Hospital
city: Swansea
country: United Kingdom
facility: Singleton Hospital
city: Wishaw
country: United Kingdom
facility: Wishaw Hospital
Study officials:
affiliation: Abbott Diabetes Care Ltd
name: Pamela Reid
role: STUDY_DIRECTOR
References: