Clinical trial NCT02665455: FreeStyle Libre in Pregnancy Study
Official title: Evaluation of the Accuracy of the FreeStyle Libre Flash Glucose Monitoring System - Use in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Sensing Technology
Lead sponsor: Abbott Diabetes Care
Sponsor class: INDUSTRY
First posted: 2016-01-27
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: Point Accuracy Determined as % Within Consensus Error Grid Zone A
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Vienna
country: Austria
facility: Medizinische Universität Wien
city: Vienna
country: Austria
facility: Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
city: Bath
country: United Kingdom
facility: Royal United Hospital
city: Bristol
country: United Kingdom
facility: Southmead Hospital
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Leeds
country: United Kingdom
facility: St. James University Hospital, Leeds Teaching Hospitals NHS Trust
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Middlesborough
country: United Kingdom
facility: James Cook University Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Warwick
country: United Kingdom
facility: Warwick Hospital
Study officials:
References: