Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Sensing Technology
Brief summary
To evaluate the point accuracy of the FreeStyle Libre Flash Glucose Monitoring System when used at home by pregnant women with diabetes.
Interventions
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.
Sponsors
Abbott Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Point Accuracy Determined as % Within Consensus Error Grid Zone A | 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. |
Countries
Austria, United Kingdom
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 83 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Intervention |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 83 Participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 83 |
| serious Total, serious adverse events | 3 / 83 |
Outcome results
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.
Time frame: 14 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Point Accuracy Determined as % Within Consensus Error Grid Zone A | 88.1 percentage of results |