N/A
N=100
An Inpatient Performance Evaluation of a New Subcutaneous Glucose Sensor
Type 1 Diabetes Mellitus · Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT01112696 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcome: Primary: Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI): Proportion of Glucose Sensor Readings That Met Accuracy Criteria — 79.45 paired sensor and YSI glucose readings
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sensor wear (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic MiniMed, Inc.
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI): Proportion of Glucose Sensor Readings That Met Accuracy Criteria |
79.45 | — |
| SECONDARY Device Related Moderate or Device Related Severe Adverse Events |
— | — |
Summary
The purpose of the study is to assess the performance of a new subcutaneous glucose sensor over a seven-day sensor life when used with currently marketed Medtronic Diabetes devices. In addition performance will be calculated for use of the new sensor with proposed new devices using new calibration algorithms.
Eligibility Criteria
Inclusion Criteria
- Males and females aged 18 through 75 inclusive
- Diagnosed with Type 1 or type 2 Diabetes Mellitus, using insulin to treat their diabetes (Each site's and overall study enrollment of subjects with Type 2 diabetes will target 20% of the total number)
- Willingness to perform required study and data collection procedures and to adhere to operating requirements of the Guardian REAL-TIME and CGMS iPro Systems
- Willingness to perform at least 4 capillary blood glucose tests per day while wearing the Guardian REAL-TIME and CGMS iPro Systems
- Willingness to participate in a 10 hour frequent blood sampling session during the study
- Subject agrees to comply with the study protocol requirements
- Informed Consent, HIPAA Authorization, and California Experimental Subject Bill of Rights (if applicable) signed by the subject
- The Subject is willing to wear both the Guardian REAL-Time and CGMS iPro Systems for 14 days (~340 hours)
Exclusion Criteria
- The Subject has a history of tape allergies that have not been resolved
- The Subject has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) that has not been resolved and would inhibit them from wearing the sensors
- Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the Subject from completing the study
- Subject is currently participating in an investigational study (drug or device)
Data sourced from ClinicalTrials.gov (NCT01112696). 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.