FreeStyle Libre in Pregnancy Study | Clinical Trial

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Freestyle LIbre Flash Glucose Monitoring System

Device

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.

Primary outcomes

Point Accuracy Determined as % Within Consensus Error Grid Zone A

Time frame: 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."

Sponsors and collaborators

Lead sponsor

Abbott Diabetes Care

Industry

Registry information

Official study title

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

Acronym: FLIPS

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Jan 27, 2016
Registry last updated: Dec 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed