Diabetes Mellitus, Type 2 Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 430 |
Est. completion date | April 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
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 | Hull Royal Infirmary | Hull | |
United Kingdom | Ipswich Hospital | Ipswich | |
United Kingdom | St James University Hospital | Leeds | |
United Kingdom | Leicester General Hospital | Leicester | |
United Kingdom | Hammersmith Hospital | London | |
United Kingdom | King's College Hospital | London | |
United Kingdom | Manchester Royal Infirmary | Manchester | |
United Kingdom | Norfolk and Norwich University Hospital | Norwich | |
United Kingdom | Churchill Hospital | Oxford | |
United Kingdom | The Adam Practice | Poole | |
United Kingdom | Queen Alexandra Hospital | Portsmouth | |
United Kingdom | Northern General Hospital | Sheffield | |
United Kingdom | Singleton Hospital | Swansea |
Lead Sponsor | Collaborator |
---|---|
Abbott Diabetes Care |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HbA1c | Difference between treatment groups in mean change from baseline in HbA1c. | 16 weeks | |
Primary | HbA1c | Difference between treatment groups in mean change from baseline in HbA1c | 32 weeks | |
Secondary | Time in range (TIR) | Time spent in glucose target range (TIR) 3.9 to 10.0 mmol/L (70 to 180 mg/dL). | 32 weeks | |
Secondary | 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). | 32 weeks | |
Secondary | 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). | 32 weeks | |
Secondary | Frequency of hypoglycaemia events | CGM detected hypoglycaemia events defined as =15 minutes duration with glucose <3.9 mmol/L (<70 mg/dL). | 32 weeks |
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