FreeStyle Libre in Pregnancy Study

Study Overview
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Brief Summary
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To evaluate the point accuracy of the FreeStyle Libre Flash Glucose Monitoring System when used at home by pregnant women with diabetes.

Official Title
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Evaluation of the Accuracy of the FreeStyle Libre Flash Glucose Monitoring System - Use in Pregnancy

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: FreeStyle Libre Flash Glucose Monitoring System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Type 1, type 2 or Gestational Diabetes Mellitus (GDM) (confirmed diagnosis via Oral Glucose Tolerance Test (OGTT)) Currently testing Blood Glucose(BG), on average at least 2 times per day Participant is ≥12+0 weeks gestation with a singleton pregnancy In the investigator's opinion, technically capable of using device Exclusion Criteria: Concomitant disease or condition that may compromise patient safety including and not limited to; cardiac disease or event, sickle cell disease, cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition Currently receiving dialysis treatment or planning to receive dialysis during the study or, moderate to advanced nephropathy (serum creatinine ≥120 micromol/litre or total protein excretion exceeds 2 g/day or urinary albumin:creatinine ratio >30 mg/mmol, estimated glomerular filtration rate (eGFR) may not be used) Diabetic Ketoacidosis (DKA) (in the previous 6 months) 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, considering guidelines (e.g. National Institute for Health and Care Excellence (NICE) and International Diabetes Federation(IDF)) for Diabetes in Pregnancy for HbA1c and Blood Pressure Experiencing any of the following conditions for current pregnancy: Pre-eclampsia HELLP syndrome (haemolysis, elevated liver enzymes and low platelet count) Prescribed Tocolytic drugs for treatment of preterm labour

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>FreeStyle Libre Flash Glucose Monitoring System | Device: FreeStyle Libre Flash Glucose Monitoring System<br>* Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days. During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point Accuracy Determined as % Within Consensus Error Grid Zone A | Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A. Zone A is defined as the zone of clinical accurate measurements with no effect on clinical action. | 14 days | 

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