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Observational Study to Evaluate the 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:
NCT01514305
First received: November 28, 2011
Last updated: January 20, 2012
Last verified: January 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.

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
Diabetes

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by DexCom, Inc.:

Primary Outcome Measures:
  • Absolute Relative Difference (%) to Reference Standard [ Time Frame: one time measure (day 1) ] [ Designated as safety issue: No ]
    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.


Enrollment: 21
Study Start Date: November 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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;

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects that fit the inclusion criteria will be chosen from the general population

Criteria

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;
  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: NCT01514305

Locations
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: NCT01514305     History of Changes
Other Study ID Numbers: PTL900830
Study First Received: November 28, 2011
Last Updated: January 20, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on November 25, 2014