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FreeStyle Libre in Pregnancy Study (FLIPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02665455
Recruitment Status : Completed
First Posted : January 27, 2016
Results First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Device: FreeStyle Libre Flash Glucose Monitoring System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of the Accuracy of the FreeStyle Libre Flash Glucose Monitoring System - Use in Pregnancy
Study Start Date : January 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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.





Primary Outcome Measures :
  1. 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."




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665455


Locations
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Austria
VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie
Feldkirch, Austria, 6807
Medizinische Universität Graz
Graz, Austria, 8036
Medizinische Universität Wien
Vienna, Austria, A-1090
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
Vienna, Austria, A-1130
United Kingdom
Royal United Hospital
Bath, United Kingdom, BA1 3NG
Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
St. James University Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
James Cook University Hospital
Middlesborough, United Kingdom, TS4 3BW
John Radcliffe Hospital
Oxford, United Kingdom, OX3 9DU
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Warwick Hospital
Warwick, United Kingdom, CV34 5BW
Sponsors and Collaborators
Abbott Diabetes Care
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Responsible Party: Abbott Diabetes Care
ClinicalTrials.gov Identifier: NCT02665455    
Other Study ID Numbers: ADC-UK-VAL-15026
First Posted: January 27, 2016    Key Record Dates
Results First Posted: December 5, 2017
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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
Keywords provided by Abbott Diabetes Care:
Diabetes Mellitus
Sensing Technology
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases