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).
Studie Overzicht
Toestand
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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California
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Escondido, California, Verenigde Staten, 92026
- Advanced Metabolic Care and Research
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Orange, California, Verenigde Staten, 92868
- CHOC Children's
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Stanford, California, Verenigde Staten, 94305
- Stanford University
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- Barbara Davis Center
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Idaho
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Idaho Falls, Idaho, Verenigde Staten, 83404
- Rocky Mountain Diabetes and Osteoporosis Center, PA
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02215
- Joslin Diabetes Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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Pediatric subjects with diabetes mellitus
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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System Performance Effectiveness
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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System Performance at Alternate Wear Site
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PTL900803
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