CGM Use in Adults With Type 2 Diabetes on Basal Insulin

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Real-Time Glucose Monitoring Using FreeStyle Libre 3 in Adults With Type 2 Diabetes On Basal Insulin Plus SGLT2 Inhibitor

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Device: FreeStyle Libre 3 Continuous Glucose Monitoring System.
* Device: Self monitoring of blood glucose


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FreeStyle Libre system<br>FreeStyle Libre 3 continuous glucose monitoring system | Device: FreeStyle Libre 3 Continuous Glucose Monitoring System.<br>* Subjects will be randomised to use the FreeStyle Libre 3 system<br>|
| Other: Standard of care (control)<br>Self monitoring of blood glucose | Device: Self monitoring of blood glucose<br>* Subjects will be randomised to continue with their current glucose monitoring system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Difference between treatment groups in mean change from baseline in HbA1c. | 16 weeks | 
| HbA1c | Difference between treatment groups in mean change from baseline in HbA1c | 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| Frequency of hypoglycaemia events | CGM detected hypoglycaemia events defined as ≥15 minutes duration with glucose <3.9 mmol/L (<70 mg/dL). | 32 weeks |