FreeStyle Libre in Pregnancy Study (FLIPS)

Abbott

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: FreeStyle Libre Flash Glucose Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02665455

ADC-UK-VAL-15026

Details and patient eligibility

About

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

Enrollment: 83 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 1 patient group

Intervention

Experimental group

Description:

FreeStyle Libre Flash Glucose Monitoring System

Treatment:

Device: FreeStyle Libre Flash Glucose Monitoring System