Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DEVICEFreeStyle Libre 3 Continuous Glucose Monitoring System.
Subjects will be randomised to use the FreeStyle Libre 3 system
Subjects will be randomised to continue with their current glucose monitoring system
Sponsors
Abbott Diabetes Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 16 weeks | Difference between treatment groups in mean change from baseline in HbA1c. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United Kingdom
Contacts
STUDY_DIRECTORPamela Reid
Abbott Diabetes Care Ltd
Outcome results
None listed