Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Sensing Technology
Brief summary
To evaluate the point accuracy of the Abbott Sensor Based Glucose Monitoring System when used at home by children with diabetes.
Interventions
Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days. During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time 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
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥ 4 years, ≤17 years * Each participant has an identified Caregiver of ≥18 years * Type 1 or type 2 diabetes using insulin administered by injections or continuous subcutaneous insulin infusion (CSII) * Currently testing blood glucose, on average at least 2 times per day * In the investigator's opinion, technically capable of using device (participant and/or caregiver).
Exclusion criteria
* Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition * Currently prescribed oral steroid therapy for any acute or chronic condition * Currently receiving dialysis treatment or planning to receive dialysis during the study * Female participant known to be pregnant * Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management * Currently using a continuous glucose monitoring (CGM) device * Known (or suspected) allergy to medical grade adhesives * In the investigator's opinion the participant or caregiver is unsuitable to participate due to any other cause/reason (both patient and caregiver considered)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Point Accuracy | 14 days | Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A. The Consensus Error Grid was developed from a survey of 100 clinicians to evaluate the accuracy of glucose measurements. Glucose results from the system under test (y) are paired with those from a reference method (x) and each (x,y) point is plotted on a grid. The grid has 5 risk categories, assigned by the clinicians surveyed. Risk categories (in order of increasing severity) are: Zone A: no effect on clinical action; Zone B: altered clinical action or little or no effect on clinical outcome; Zone C: altered clinical action likely to effect clinical outcome; Zone D: altered clinical action, could have significant medical risk; Zone E: altered clinical action, could have dangerous consequences. Result were calculated for all subjects ie total number of sensor results and fingerstick blood glucose results divided by the total number of results x 100. |
Countries
United Kingdom
Participant flow
Pre-assignment details
A total of 89 subjects consented and were enrolled into the study.
Participants by arm
| Arm | Count |
|---|---|
| FreeStyle Libre Flash Glucose Monitoring System FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.
During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed. | 89 |
| Total | 89 |
Baseline characteristics
| Characteristic | FreeStyle Libre Flash Glucose Monitoring System |
|---|---|
| Age, Categorical <=18 years | 89 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United Kingdom | 89 participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 15 / 89 |
| serious Total, serious adverse events | 1 / 89 |
Outcome results
Primary
Point Accuracy
Point accuracy of Sensor based glucose values versus fingerstick blood glucose determined as % within Consensus Error Grid zone A. The Consensus Error Grid was developed from a survey of 100 clinicians to evaluate the accuracy of glucose measurements. Glucose results from the system under test (y) are paired with those from a reference method (x) and each (x,y) point is plotted on a grid. The grid has 5 risk categories, assigned by the clinicians surveyed. Risk categories (in order of increasing severity) are: Zone A: no effect on clinical action; Zone B: altered clinical action or little or no effect on clinical outcome; Zone C: altered clinical action likely to effect clinical outcome; Zone D: altered clinical action, could have significant medical risk; Zone E: altered clinical action, could have dangerous consequences. Result were calculated for all subjects ie total number of sensor results and fingerstick blood glucose results divided by the total number of results x 100.
Time frame: 14 days
Population: One subject withdrew prior to having a sensor applied, another did not perform any blood glucose tests on the FreeStyle Libre. Neither subject could be included in the accuracy analysis, both are included in the safety analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| FreeStyle Libre Flash Glucose Monitoring System | Point Accuracy | 83.8 percentage of glucose results in zone A |