CGM Use in Adults With Type 2 Diabetes on Basal Insulin
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Device: Self monitoring of blood glucoseDevice: FreeStyle Libre 3 Continuous Glucose Monitoring System.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 470
- 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).
- 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
- Arm && Interventions
Group Intervention Description Standard of care (control) Self monitoring of blood glucose Self monitoring of blood glucose FreeStyle Libre system FreeStyle Libre 3 Continuous Glucose Monitoring System. FreeStyle Libre 3 continuous glucose monitoring system
- 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 Frequency of hypoglycaemia events 32 weeks CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose \<3.9 mmol/L (\<70 mg/dL).
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).
Trial Locations
- Locations (25)
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom
Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
St Mary's Hospital
🇬🇧London, United Kingdom
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
Ipswich Hospital
🇬🇧Ipswich, United Kingdom
St James University Hospital
🇬🇧Leeds, United Kingdom
Leicester General Hospital
🇬🇧Leicester, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
The Adam Practice
🇬🇧Poole, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom
Moorgreen Hospital
🇬🇧Southampton, United Kingdom
Singleton Hospital
🇬🇧Swansea, United Kingdom
Wishaw Hospital
🇬🇧Wishaw, United Kingdom