Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT01514292
First received: January 12, 2012
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

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 >18 years-old with diabetes mellitus.

The primary objective is to characterize the System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the G4 System in reference to YSI.

Safety of the G4 System will be characterized by Adverse Device Effects and Serious Adverse Device Effects experienced by study participants.


Condition Intervention
Diabetes
Device: Continuous Glucose Monitoring of glucose levels (Dexcom)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PTL-900590 Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System

Resource links provided by NLM:


Further study details as provided by DexCom, Inc.:

Primary Outcome Measures:
  • Device Performance with respect to YSI lab reference [ Time Frame: Outcome measured at 7 days, post sensor insertion ] [ Designated as safety issue: No ]
    The primary objective is to characterize the G4 System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the G4 System in reference to YSI.


Enrollment: 72
Study Start Date: December 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Continuous Glucose Monitoring of glucose levels (Dexcom)
    Manipulation of glucose levels during multiple clinic days. Achieved through diet, exercise and insulin regimen defined in protocol.Evaluation of CGM sensitivity to range of glucose levels
    Other Names:
    • CGM System
    • G4 CGM System
    • Dexcom G4 CGM System
Detailed Description:

The primary objective is to characterize the System performance with respect to laboratory reference venous sample measurements. The device performance will be primarily evaluated in terms of point and rate accuracy of the G4 System in reference to YSI. The trend accuracy of the device performance, i.e., continuous glucose error grid analysis, will be evaluated as well as the temporal G4 System 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 multiple in-clinic days.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older;
  • Diagnosed with diabetes mellitus;
  • Use one of the following for their diabetes management:

    • intensive insulin therapy (IIT) or
    • non-intensive insulin therapy (non-IIT)
  • Intensive-insulin using (IIT) subjects only - During each in-clinic session, willing to have their blood glucose levels manipulated into high and low glucose levels. Subjects not on IIT will only be observed during each in-clinic session.
  • For subjects that exercise routinely (at least 3 times per week), willing to exercise on each in-clinic session, if asked;
  • Willing to take a minimum of 7 fingersticks per day during home use days;
  • Willing to refrain from the use of acetaminophen during sensor wear period and the day prior to sensor insertion;

Exclusion Criteria:

  • Have 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;
  • Have a known allergy to medical-grade adhesives;
  • Are pregnant as demonstrated by a positive pregnancy test within 72 hours of sensor insertion,
  • Are on dialysis;
  • Have a hematocrit that is less than 36% or greater than 55% at screening visit;
  • Currently participating 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);
  • Have a history of cardiovascular disease (including, but not limited to ischemic heart disease, peripheral vascular disease, cardiomyopathy, cerebrovascular disease, congenital heart disease, or significant arrhythmias), epilepsy, severe migraines in the past 6 months, adrenal disease, syncope, significant hypoglycemia unawareness, or a history of severe hypoglycemia (requiring emergency medical intervention) within the last 6 months;
  • Have any chronic infectious disease or intercurrent illness that would interfere with their participation in the study or pose an excessive risk to study staff handling venous or capillary blood samples (e.g. HIV/AIDS, Hepatitis B or C);
  • Have a MRI scan, CT scan, or diathermy scheduled during the week of the study. If any of these procedures are required urgently during the study, subjects will notify the study staff, end their CGM session, and remove their sensor.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01514292

Locations
United States, California
Profil Institute for Clinical Research
Chula Vista, California, United States, 91911
AMCR Institute, Inc.
Escondido, California, United States, 92026
Diablo Clinical Research
Walnut Creek, California, United States, 94598
United States, Idaho
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States, 83404
Sponsors and Collaborators
DexCom, Inc.
Investigators
Study Director: David Price, MD DexCom, Inc.
  More Information

No publications provided

Responsible Party: DexCom, Inc.
ClinicalTrials.gov Identifier: NCT01514292     History of Changes
Other Study ID Numbers: PTL-900590
Study First Received: January 12, 2012
Last Updated: August 20, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 19, 2014