FreeStyle Libre in Pregnancy Study

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: FreeStyle Libre Flash Glucose Monitoring System

• Registration Number: NCT02665455
• Lead Sponsor: Abbott Diabetes Care

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-27
• Primary Completion: 2016-06
• Study Completion: 2016-09
• Results First Submitted: 2017-06-27
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-04
• Last Update Submitted: 2017-12-04
• Results First Posted: 2017-12-05
• Last Update Posted: 2017-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 83

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	FreeStyle Libre Flash Glucose Monitoring System	FreeStyle Libre Flash Glucose Monitoring System

Primary Outcome Measures

Name	Time	Method
Point Accuracy Determined as % Within Consensus Error Grid Zone A	14 days	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."

Trial Locations

Locations (13)

Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom

James Cook University Hospital; 🇬🇧 Middlesborough, United Kingdom

John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom

Derriford Hospital; 🇬🇧 Plymouth, United Kingdom

Warwick Hospital; 🇬🇧 Warwick, United Kingdom

Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom

Royal United Hospital; 🇬🇧 Bath, United Kingdom

Southmead Hospital; 🇬🇧 Bristol, United Kingdom

St. James University Hospital, Leeds Teaching Hospitals NHS Trust; 🇬🇧 Leeds, United Kingdom

Medizinische Universität Wien; 🇦🇹 Vienna, Austria

Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel; 🇦🇹 Vienna, Austria

Medizinische Universität Graz; 🇦🇹 Graz, Austria

VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie; 🇦🇹 Feldkirch, Austria