N/A
Completed N=89
Abbott Sensor Based Glucose Monitoring System Paediatric Study
Source: ClinicalTrials.gov NCT02388815 ↗Enrolled (actual)
89
Serious AEs
1.1%
Results posted
Apr 2016
Primary outcomePrimary: Point Accuracy — 83.8 percentage of glucose results in zone A
Summary
To evaluate the point accuracy of the Abbott Sensor Based Glucose Monitoring System when used at home by children with diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Point Accuracy |
83.8 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02388815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.