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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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.

Country

City, postcode or hospital

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

Other trials in United Kingdom

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

Other trials in Austria

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 groups in NCT02665455
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.

Jan 2016Sep 2016

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
RecruitingObservational study
Taste Bud-Derived Stem Cells in Humans
Diabetes
RecruitingObservational study
Human iPSC for Repair of Vasodegenerative Vessels in Diabetic Retinopathy
Diabetes Complications, Diabetic Retinopathy
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity

All Diabetes Mellitus trials

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

Results posted to the registry on 5 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention	83	74

Primary outcome: Point Accuracy Determined as % Within Consensus Error Grid Zone A

Time frame: 14 days. Number (95% Confidence Interval). Unit: percentage of results

Measure	Intervention n = 74
Value	88.1 (86 to 89.6)

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention	3 of 83 (3.6%)	0 of 83 (0%)	Not reported

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

Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
RecruitingObservational study
Taste Bud-Derived Stem Cells in Humans
Diabetes
RecruitingObservational study
Human iPSC for Repair of Vasodegenerative Vessels in Diabetic Retinopathy
Diabetes Complications, Diabetic Retinopathy
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity

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?

On the ClinicalTrials.gov record for NCT02665455.

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; AzTrials last refreshed its copy on 27 Oct 2026.