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Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT01667185
First received: August 15, 2012
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


Condition
Pediatric Subjects With Diabetes Mellitus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

Further study details as provided by DexCom, Inc.:

Primary Outcome Measures:
  • System Performance Effectiveness [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    The primary objective is to characterize System effectiveness in comparison with the laboratory reference YSI venous sample measurements.


Secondary Outcome Measures:
  • System Performance at Alternate Wear Site [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 176
Study Start Date: July 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Pediatric subjects with diabetes mellitus

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric subjects with diabetes mellitus

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667185

Locations
United States, California
Advanced Metabolic Care and Research
Escondido, California, United States, 92026
CHOC Children's
Orange, California, United States, 92868
Stanford University
Stanford, California, United States, 94305
United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80045
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center, PA
Idaho Falls, Idaho, United States, 83404
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
DexCom, Inc.
  More Information

No publications provided

Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT01667185     History of Changes
Other Study ID Numbers: PTL900803
Study First Received: August 15, 2012
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by DexCom, Inc.:
pediatric
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 16, 2013