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Trial record 23 of 2647 for:    ( Map: Idaho, United States )

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

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: NCT01514305
Recruitment Status : Completed
First Posted : January 23, 2012
Last Update Posted : January 23, 2012
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.

Device performance will be primarily evaluated in terms of the proportion of glucose values within a pre-specified range compared to reference values.

Safety data of the G4 System will also be collected vis-a-vis adverse event reporting characterized by the incidence and severity of Serious Adverse Device Events, and Adverse Device Events experienced by study participants.

Condition or disease

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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Observational Study to Evaluate the Effectiveness and Safety Study of the Dexcom G4™ Continuous Glucose Monitoring System
Study Start Date : November 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Type 1 Diabetes Mellitus (TIDM)Type 2 Diabetes Mellitus (T2DM)
Adults that have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;

Primary Outcome Measures :
  1. Absolute Relative Difference (%) to Reference Standard [ Time Frame: one time measure (day 1) ]
    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 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.

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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects that fit the inclusion criteria will be chosen from the general population

Inclusion Criteria:

  1. Age 18 years or older;
  2. Have been diagnosed with insulin-requiring diabetes
  3. Abstain from injecting insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear;
  4. Insert sensors on their own and wear 2 systems simultaneously;
  5. Use only the blood glucose meter provided for all blood glucose measurements performed during sensor wear and not allow others to use this meter during the study;
  6. Participate in one in-clinic session comprising of fingersticks per hour and have blood draws for the entire in-clinic session;
  7. Have an intravenous catheter inserted for 4 blood draws per hour
  8. Willing to perform SMBG during home use with the meter provided;
  9. Refrain from the use of acetaminophen during sensor wear period and the day prior to sensor insertion;
  10. Speak, read, and write English;
  11. Willing and able to be compliant with provisions laid out in this protocol.

Exclusion Criteria:

  1. Have extensive skin changes/diseases that preclude wearing 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;
  2. Allergy to medical-grade adhesives;
  3. Pregnant as demonstrated by a positive pregnancy test within 72 hours of sensor insertion,
  4. Dialysis treatment;
  5. Hematocrit that is outside the range of 30-55% at screening visit;

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): NCT01514305

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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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Study Director: David Price, MD DexCom, Inc.

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Responsible Party: DexCom, Inc. Identifier: NCT01514305     History of Changes
Other Study ID Numbers: PTL900830
First Posted: January 23, 2012    Key Record Dates
Last Update Posted: January 23, 2012
Last Verified: January 2012