FreeStyle Libre Pro Use in Primary & Secondary Care

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the impact of varying amount of FreeStyle Libre Pro wear as measured by time in range.

Official Title
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Evaluation of the FreeStyle Libre Pro for Individuals With Insulin Managed Type 2 Diabetes in Primary & Secondary Care

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: FreeStyle Libre Pro 4 sensor wears, 2 with reviews
* Device: FreeStyle Libre Pro 6 sensor wears, 4 with reviews
* Device: FreeStyle Libre Pro 3 sensor wears


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at least 18 years. Type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment. HbA1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive. Exclusion Criteria: Age at least 18 years. Type 2 diabetes treated with insulin therapy for at least 6 months prior to study enrolment. HbA1c between 58 and 108 mmol/mol (7.5 and 12.0%) inclusive. Participant is currently prescribed animal insulin. Total daily dose of insulin (TDD) is >1.75 iu/kg at entry to the study. Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition. Has a pacemaker or any other neurostimulators. Currently prescribed oral, intramuscular or intravenous steroid therapy for any acute or chronic condition or requires it during the study period. Currently receiving dialysis treatment or planning to receive dialysis during the study. Women who are pregnant, plan to become pregnant or become pregnant during the study. Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management. Currently using / has previously used a sensor based Glucose Monitoring System (including retrospective glucose monitoring system) within the last 6 months. Currently using Continuous Subcutaneous Insulin Infusion (CSII). Known (or suspected) allergy to medical grade adhesives. In the investigator's opinion the participant is unsuitable to participate due to any other cause/reason.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A - Control<br>FreeStyle Libre Pro 3 sensor wears | Device: FreeStyle Libre Pro 3 sensor wears<br>* Subjects will wear the FreeStyle Libre Pro System for 14 days. 3 periods of Sensor wear for time in range measurement over a period of approximately 8 months.<br>|
| Experimental: Group B - Intervention<br>FreeStyle Libre Pro 4 sensor wears, 2 with reviews | Device: FreeStyle Libre Pro 4 sensor wears, 2 with reviews<br>* Subjects will wear the FreeStyle Libre Pro System for 14 days. 2 period of FreeStyle Libre Pro Sensor wear for data review followed by 2 further periods of Sensor wear for time in range measurement with 28 day interval between wears.<br>|
| Experimental: Group C - Intervention<br>FreeStyle Libre Pro 6 sensor wears, 4 with reviews | Device: FreeStyle Libre Pro 6 sensor wears, 4 with reviews<br>* Subjects will wear the FreeStyle Libre Pro System for 14 days. 4 period of FreeStyle Libre Pro Sensor wear for data review followed by 2 further periods of Sensor wear for time in range measurement with 28 day interval between wears.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline - time in glucose range - for penultimate sensor wear | Within arm difference in time in range in penultimate period of sensor wear compared to baseline phase | 14 day baseline phase compared to day 172 to 187 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Sensing Technology