Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
83 participants
INTERVENTIONAL
2016-01-31
2016-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
FreeStyle Libre Flash Glucose Monitoring System
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Abbott Diabetes Care
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie
Feldkirch, , Austria
Medizinische Universität Graz
Graz, , Austria
Medizinische Universität Wien
Vienna, , Austria
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
Vienna, , Austria
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
Middlesbrough, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Warwick Hospital
Warwick, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ADC-UK-VAL-15026
Identifier Type: -
Identifier Source: org_study_id