Diabetes MellitusFLIPSNCT02665455
FreeStyle Libre in Pregnancy Study
A study testing FreeStyle Libre Flash Glucose Monitoring System in people with Diabetes Mellitus, run by Abbott Diabetes Care at 13 sites in 2 countries.
Trial summary
To evaluate the point accuracy of the FreeStyle Libre Flash Glucose Monitoring System when used at home by pregnant women with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- FreeStyle Libre Flash Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jan 2016to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 9Show fewer
- Pre-eclampsia
- HELLP syndrome (haemolysis, elevated liver enzymes and low platelet count)
- Prescribed Tocolytic drugs for treatment of preterm labour
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United Kingdom9 sites
Royal United Hospital
Bath, BA1 3NG
Southmead Hospital
Bristol, BS10 5NB
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
St. James University Hospital, Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
Manchester Royal Infirmary
Manchester, M13 9WL
James Cook University Hospital
Middlesbrough, TS4 3BW
John Radcliffe Hospital
Oxford, OX3 9DU
Derriford Hospital
Plymouth, PL6 8DH
Warwick Hospital
Warwick, CV34 5BW
Austria4 sites
VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie
Feldkirch, 6807
Medizinische Universität Graz
Graz, 8036
Medizinische Universität Wien
Vienna, A-1090
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
Vienna, A-1130
About this study
Official title: Evaluation of the Accuracy of the FreeStyle Libre Flash Glucose Monitoring System - Use in Pregnancy
To evaluate the point accuracy of the FreeStyle Libre Flash Glucose Monitoring System when used at home by pregnant women with diabetes.
- Conditions
- Diabetes Mellitus
- Being tested
- FreeStyle Libre Flash Glucose Monitoring System
- Keywords
- Diabetes Mellitus, Sensing Technology
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre Flash Glucose Monitoring SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | FreeStyle Libre Flash Glucose Monitoring System Receives: Device: FreeStyle Libre Flash Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02665455
- Sponsor's protocol ID
- ADC-UK-VAL-15026
- Acronym
- FLIPS
- Status last verified
- Dec 2017
- First submitted
- 25 Jan 2016
- Last updated
- 5 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Objective of study is to confirm accuracy of device in this patient population, so data cannot be shared with subjects until this is established
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of the FreeStyle Libre Flash Glucose Monitoring System - Use in Pregnancy
- ClinicalTrials.gov ID
- NCT02665455
- Acronym / sponsor ID
- FLIPS / ADC-UK-VAL-15026
- Conditions
- Diabetes Mellitus
- Keywords
- Diabetes Mellitus, Sensing Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Abbott Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 Jan 2016 (estimated)
- Results
- Posted 5 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the point accuracy of the FreeStyle Libre Flash Glucose Monitoring System when used at home by pregnant women with diabetes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: FreeStyle Libre Flash Glucose Monitoring SystemFreeStyle Libre Flash Glucose Monitoring System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FreeStyle Libre Flash Glucose Monitoring SystemSubjects 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. | Device | Intervention |
Primary outcome
Point Accuracy Determined as % Within Consensus Error Grid Zone A
Time frame: 14 days
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."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Objective of study is to confirm accuracy of device in this patient population, so data cannot be shared with subjects until this is established
Related trials for Diabetes Mellitus
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Active, not recruitingObservational study
EFFECT OF HYBRID CLOSED-LOOP SYSTEMS ON CARDIOVASCULAR MARKERS IN TYPE 1 DIABETES.
Type 1 Diabetes
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
RecruitingObservational study
A Natural History Study of Metabolic Sizing in Health and Disease
Metabolic Disorders, Cancer
Recruiting
Insulin-Mediated Glucose Uptake and Organ Perfusion Assessed by Total-Body PET During GIP and GLP-1 Infusion
Type 2 Diabetes, Healhty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre Flash Glucose Monitoring System in people with Diabetes Mellitus, run by Abbott Diabetes Care at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point Accuracy Determined as % Within Consensus Error Grid Zone A (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.