FreeStyle Libre in Pregnancy Study
FLIPS
Evaluation of the Accuracy of the FreeStyle Libre Flash Glucose Monitoring System - Use in Pregnancy
1 other identifier
interventional
83
2 countries
13
Brief Summary
To evaluate the point accuracy of the FreeStyle Libre Flash Glucose Monitoring System when used at home by pregnant women with diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus
Started Jan 2016
Shorter than P25 for not_applicable diabetes-mellitus
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 25, 2016
CompletedFirst Posted
Study publicly available on registry
January 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedResults Posted
Study results publicly available
December 5, 2017
CompletedDecember 5, 2017
December 1, 2017
5 months
January 25, 2016
June 27, 2017
December 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Intervention
EXPERIMENTALFreeStyle Libre Flash Glucose Monitoring System
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie
Feldkirch, 6807, Austria
Medizinische Universität Graz
Graz, 8036, Austria
Medizinische Universität Wien
Vienna, A-1090, Austria
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
Vienna, A-1130, Austria
Royal United Hospital
Bath, BA1 3NG, United Kingdom
Southmead Hospital
Bristol, BS10 5NB, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
St. James University Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF, United Kingdom
Manchester Royal Infirmary
Manchester, M13 9WL, United Kingdom
James Cook University Hospital
Middlesbrough, TS4 3BW, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Warwick Hospital
Warwick, CV34 5BW, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jolyon Bugler, Snr Director Clinical Development & Regulatory Affairs
- Organization
- Abbott Diabetes Care
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2016
First Posted
January 27, 2016
Study Start
January 1, 2016
Primary Completion
June 1, 2016
Study Completion
September 1, 2016
Last Updated
December 5, 2017
Results First Posted
December 5, 2017
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share
Objective of study is to confirm accuracy of device in this patient population, so data cannot be shared with subjects until this is established