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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus | Device: FreeStyle Libre Flash Glucose Monitoring System | Not Applicable |
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 |

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. |
- 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."

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

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
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 |
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 |
Diabetes Mellitus Sensing Technology |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |