FreeStyle Libre in Pregnancy Study

Diabetes Mellitus Clinical Trial

— FLIPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02665455
• Other study ID #: ADC-UK-VAL-15026
• Status: Completed
• Phase: N/A
• First received: January 25, 2016
• Last updated: December 4, 2017
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: December 2017
• Source: Abbott Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
Austria	VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie	Feldkirch
Austria	Medizinische Universität Graz	Graz
Austria	Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel	Vienna
Austria	Medizinische Universität Wien	Vienna
United Kingdom	Royal United Hospital	Bath
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	St. James University Hospital, Leeds Teaching Hospitals NHS Trust	Leeds
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	James Cook University Hospital	Middlesborough
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Warwick Hospital	Warwick

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Diabetes Care

Countries where clinical trial is conducted

Austria,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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