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CompletedNCT01514305Updated Jan 23, 2012

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

An observational study in Diabetes, sponsored by DexCom, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-23.

Sponsored by DexCom, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
21
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
03

In context

Lead sponsor

DexCom, Inc. is the lead sponsor of 35 studies on the registry; 1 is open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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;
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
21 participants (actual)

Groups and 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;

06

What researchers measure

Primary outcomes

  1. Absolute Relative Difference (%) to Reference Standard

    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.

    Time frame: one time measure (day 1)

07

Study locations

1 site
  • Rocky Mountain Diabetes and Osteoporosis Center
    Idaho Falls, Idaho 83404, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01514305
Lead sponsor
DexCom, Inc.
Responsible party
Sponsor
First posted
Jan 23, 2012
Start date
Nov 2011
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Jan 23, 2012

Study contacts

David Price, MD
study director · DexCom, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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