N/A
Completed N=83
New Glucose Sensor Pediatric
Source: ClinicalTrials.gov NCT01161043 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Glucose Sensor Accuracy When Compared to SMBG: Proportion of Glucose Sensor Readings That Met Accuracy Criteria [Time Frame: Days One Through Six of Sensor Use] — 72.4 % of paired SMBG/Sensor glucose values
Summary
The purpose of this study is to assess performance of a new subcutaneous glucose sensor over a seven day sensor life when used with currently marketed Medtronic Diabetes devices. In addition performance of the new sensor will be calculated for use of the new sensor with proposed new devices using new calibration algorithms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucose Sensor Accuracy When Compared to SMBG: Proportion of Glucose Sensor Readings That Met Accuracy Criteria [Time Frame: Days One Through Six of Sensor Use] |
72.4 | — |
| SECONDARY Device Related Moderate or Device Related Severe Adverse Events |
— | — |
Eligibility Criteria
Inclusion Criteria
- Males and females aged 7 through 17 inclusive
- Diagnosed with Type 1 Diabetes Mellitus
- Willingness to perform required study and data collection procedures and to adhere to operating requirements of the Guardian REAL-TIME System
- Willingness to perform at least 4 capillary blood glucose tests per day while wearing the Guardian REAL-TIME System
- Subject agrees to comply with the study protocol requirements
- Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights (if applicable) signed by the subject and/or parent/guardian
- The Subject is willing to wear the Guardian REAL-Time System for 14 days (~340 hours).
Exclusion Criteria
- The Subject has a history of tape allergies that have not been resolved at time of enrollment
- The Subject has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) in the area of sensor placement that have not been resolved at the time of enrollment and would inhibit them from wearing the sensors
- Subject has a positive pregnancy test on enrollment
- Subject is currently participating in an investigational study (drug or device)
Data sourced from ClinicalTrials.gov (NCT01161043). 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.