FreeStyle Libre in Pregnancy Study

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02665455
• Date of registration: 25/01/2016
• Prospective Registration: No
• Primary sponsor: Abbott Diabetes Care
• Public title: FreeStyle Libre in Pregnancy Study FLIPS
• Scientific title: Evaluation of the Accuracy of the FreeStyle Libre Flash Glucose Monitoring System - Use in Pregnancy
• Date of first enrolment: January 2016
• Target sample size: 83
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02665455
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, United Kingdom

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Intervention(s)

Device: FreeStyle Libre Flash Glucose Monitoring System

Primary Outcome(s)

Point Accuracy Determined as % Within Consensus Error Grid Zone A [Time Frame: 14 days]

Secondary ID(s)

ADC-UK-VAL-15026

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 05/12/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02665455