N/A N=83 Other

FreeStyle Libre in Pregnancy Study

Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT02665455 ↗

Enrolled (actual)

Serious AEs

3.6%

Results posted

Dec 2017

Primary outcome: Primary: Point Accuracy Determined as % Within Consensus Error Grid Zone A — 88.1 percentage of results

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FreeStyle Libre Flash Glucose Monitoring System (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Abbott Diabetes Care
Primary completion: Jun 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Point Accuracy Determined as % Within Consensus Error Grid Zone A	88.1	—

Summary

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02665455). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.