- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01667185
Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus
Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus.
The primary objective of the study is to evaluate the safety and effectiveness of the G4 System (System) when used as an adjuvant to blood glucose testing over a 7-day period in pediatric subjects with diabetes mellitus.
System effectiveness will be primarily evaluated with comparison to laboratory reference Yellow Springs Instrument (YSI) venous sample measurements. The system performance will be evaluated in terms of point and rate accuracy of the system in reference to YSI. The point accuracy is measured as the proportion of G4 System values that are within ±20% of YSI reference value for glucose levels >80 mg/dL and ±20 mg/dL at YSI glucose levels <80 mg/dL. The trend accuracy of the device performance, i.e., continuous glucose error grid analysis, will be evaluated as well as the temporal accuracy at different glucose rates of changes and different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges). The primary matched paired (Sensor-YSI) measurements will be collected during one in-clinic session. System effectiveness will also be evaluated with SMBG measurements similarly.
Safety data of the system will also be collected and safety will be characterized by the incidence of Adverse Device Effects (ADE) experienced by study participants.
Other objectives include the evaluation of device performance at an alternate site (the upper buttocks).
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Escondido, California, United States, 92026
- Advanced Metabolic Care and Research
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Orange, California, United States, 92868
- CHOC Children's
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Stanford, California, United States, 94305
- Stanford University
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Colorado
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Aurora, Colorado, United States, 80045
- Barbara Davis Center
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Rocky Mountain Diabetes and Osteoporosis Center, PA
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Massachusetts
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Boston, Massachusetts, United States, 02215
- Joslin Diabetes Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Ages 2 to 17 years ;
- Diagnosis of diabetes mellitus;
- Willing to participate in one 7-day Sensor wear period;
- Willing to wear 2 systems simultaneously;
- Willing to take a minimum of 7 fingersticks per day during home use with a blood glucose meter provided;
- Willing to attend one in-clinic session of up to 6 hours duration. Clinic procedures where blood sampling via SMBG and/or venous YSI method, depending on age;
- Subject or guardian is able to speak, read, and write English.
Exclusion Criteria:
- Extensive skin changes/diseases at sensor wear site that preclude wearing the Sensor on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis);
- Known allergy to medical-grade adhesives;
- Require a magnetic resonance imaging (MRI) scan, computed tomography (CT) scan, or diathermy during the wear period. If any of these procedures are required urgently during the study, subjects will notify the study staff, end their continuous glucose monitoring (CGM) session, and remove their sensor.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Pediatric subjects with diabetes mellitus
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
System Performance Effectiveness
Time Frame: 7 days
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The primary objective is to characterize System effectiveness in comparison with the laboratory reference YSI venous sample measurements.
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7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
System Performance at Alternate Wear Site
Time Frame: 7 days
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An additional objective is to evaluate System performance at an alternate wear site.
The System performance will be assessed, using the same statistical methodology as the primary wear site.
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7 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTL900803
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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