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Trial record 15 of 2647 for:    ( Map: Idaho, United States )

Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4 Continuous Glucose Monitoring System in Pediatrics

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: NCT02363907
Recruitment Status : Completed
First Posted : February 16, 2015
Results First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Information provided by (Responsible Party):
DexCom, Inc.

Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing over a 7-day period in people 2 to 17 years-old with diabetes mellitus.

Condition or disease
Diabetes Mellitus

Detailed Description:

Performance of the system will be primarily evaluated by comparing the blood glucose measurements from the reference device, a blood glucose meter, to the CGM System values collected during the study. Specifically, performance will be primarily evaluated in terms of the proportion of G4 System values that are within ±20% of glucose meter reference value for glucose levels >80 mg/dL and ±20 mg/dL of glucose meter reference values <80 mg/dL. These G4-meter matched pairs will be analyzed across the 7 days of wear.

Safety data of the CGM System will also be collected and safety will be characterized by the incidence of anticipated device-related adverse events (ADEs) of subjects who participate in the study.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4
Study Start Date : September 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Primary Outcome Measures :
  1. Point Accuracy of CGM ISF Readings to Blood Glucose Measured by a Reference Device [ Time Frame: Measured during clinic session during 7 day sensor wear period ]
    "Point Accuracy was evaluated in terms of the percentage of CGM values that were within ±20% of glucose meter reference value for glucose levels >80 mg/dL and ±20 mg/dL of glucose meter reference values for glucose levels <80 mg/dL

Information from the National Library of Medicine

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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
Children and adolescents with diabetes mellitus (Type 1 or Type 2)

Inclusion Criteria:

  • Ages 2 to 17 years;
  • Diagnosis of diabetes mellitus;
  • Treatment of diabetes with insulin and/or oral diabetes medication Note: Insulin-using subjects only - willing to avoid insulin injections or wear an insulin pump insertion set within 3 inches from the sensor site;
  • Willing to refrain from the use of medications containing acetaminophen during the sensor insertion period and for one day prior to sensor insertion;
  • Able to perform up to 7 fingersticks per day during home use (approximately 2 calibration fingersticks or as often as prompted by the device and approximately 5 for diabetes management and/or detection of hyper and hypoglycemia); and
  • Subject or guardian is able to speak, read, and write English.

Exclusion Criteria:

  • Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
  • Known allergy to medical-grade adhesives;
  • For subjects of childbearing potential: are pregnant as demonstrated by a positive pregnancy test within 72 hours prior to device insertion;
  • Hematocrit value outside the range of the blood glucose monitoring system used in the study;
  • Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study);
  • Planned MRI scan, CT scan, or diathermy during the week of the study; or
  • Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial (e.g., marked visual impairment) or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C, or HIV).

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): NCT02363907

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United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
Sponsors and Collaborators
DexCom, Inc.
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Principal Investigator: David Liljenquist, M.D. Rocky Mountain Diabetes and Osteoporosis Center

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Responsible Party: DexCom, Inc. Identifier: NCT02363907     History of Changes
Other Study ID Numbers: PTL-900982
First Posted: February 16, 2015    Key Record Dates
Results First Posted: July 27, 2017
Last Update Posted: July 27, 2017
Last Verified: February 2015
Keywords provided by DexCom, Inc.:
diabetes mellitus
continuous glucose monitoring system
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases