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To evaluate the point accuracy of the FreeStyle Libre Flash Glucose Monitoring System when used at home by pregnant women with diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | FreeStyle Libre Flash Glucose Monitoring System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FreeStyle Libre Flash Glucose Monitoring System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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." | 14 days |
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Inclusion Criteria:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VIVIT-Institut am Akad. Lehrkrankenhaus Feldkirch, Innere Medizin und Kardiologie | Feldkirch | 6807 | Austria | |||
Objective of study is to confirm accuracy of device in this patient population, so data cannot be shared with subjects until this is established
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Eighty-three (83) participants were consented. Nine of the 83 participants withdrew from the study on or before Visit 1 and before the device was worn or used. All 74 participants that wore a sensor are included in the analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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." | Posted | Number | 95% Confidence Interval | percentage of results | 14 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pre eclampsia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | None of the Serious Adverse Events are device related. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jolyon Bugler, Snr Director Clinical Development & Regulatory Affairs | Abbott Diabetes Care | +44 1993 863094 | joe.bugler@abbott.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
| Medizinische Universität Graz |
| Graz |
| 8036 |
| Austria |
| Medizinische Universität Wien | Vienna | A-1090 | Austria |
| Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel | Vienna | A-1130 | Austria |
| Royal United Hospital | Bath | BA1 3NG | United Kingdom |
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| St. James University Hospital, Leeds Teaching Hospitals NHS Trust | Leeds | LS9 7TF | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
| John Radcliffe Hospital | Oxford | OX3 9DU | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Warwick Hospital | Warwick | CV34 5BW | United Kingdom |
| Protocol Violation |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 3 |
| 83 |
| 0 |
| 83 |
|
| Vomiting & epigastric pain | Gastrointestinal disorders | Non-systematic Assessment | None of the Serious Adverse Events are device related. |
|
| Decreased foetal movements | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | None of the Serious Adverse Events are device related. |
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