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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01667185
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : February 8, 2013
Information provided by (Responsible Party):
DexCom, Inc.

Brief Summary:

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 or disease
Pediatric Subjects With Diabetes Mellitus

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Study Type : Observational
Actual Enrollment : 176 participants
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.
Study Start Date : July 2012
Actual Primary Completion Date : December 2012

Pediatric subjects with diabetes mellitus

Primary Outcome Measures :
  1. System Performance Effectiveness [ Time Frame: 7 days ]
    The primary objective is to characterize System effectiveness in comparison with the laboratory reference YSI venous sample measurements.

Secondary Outcome Measures :
  1. System Performance at Alternate Wear Site [ Time Frame: 7 days ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric subjects with diabetes mellitus

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01667185

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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.
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Responsible Party: DexCom, Inc. Identifier: NCT01667185    
Other Study ID Numbers: PTL900803
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013
Keywords provided by DexCom, Inc.:
diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases