FreeStyle Libre in Pregnancy Study (FLIPS)

December 4, 2017 updated by: Abbott Diabetes Care

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria, 6807
        • VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie
      • Graz, Austria, 8036
        • Medizinische Universität Graz
      • Vienna, Austria, A-1090
        • Medizinische Universitat Wien
      • Vienna, Austria, A-1130
        • Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
  • United Kingdom
      • Bath, United Kingdom, BA1 3NG
        • Royal United Hospital
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Foundation Trust
      • Leeds, United Kingdom, LS9 7TF
        • St. James University Hospital, Leeds Teaching Hospitals NHS Trust
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Infirmary
      • Middlesborough, United Kingdom, TS4 3BW
        • James Cook University Hospital
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Warwick, United Kingdom, CV34 5BW
        • Warwick Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
FreeStyle Libre Flash Glucose Monitoring System
Device: FreeStyle Libre Flash Glucose Monitoring System

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Diabetes Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 27, 2016

Study Record Updates

Last Update Posted (Actual)

December 5, 2017

Last Update Submitted That Met QC Criteria

December 4, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADC-UK-VAL-15026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Objective of study is to confirm accuracy of device in this patient population, so data cannot be shared with subjects until this is established

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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