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

NCT01514305 | Completed

• 1 other identifier: PTL900830
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

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.

  one time measure (day 1)

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age 18 years or older;
• Have been diagnosed with insulin-requiring diabetes
• Abstain from injecting insulin or wear an insulin pump insertion set within 3 inches from the sensor site during sensor wear;
• Insert sensors on their own and wear 2 systems simultaneously;
• 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;
• Participate in one in-clinic session comprising of fingersticks per hour and have blood draws for the entire in-clinic session;
• Have an intravenous catheter inserted for 4 blood draws per hour
• Willing to perform SMBG during home use with the meter provided;
• Refrain from the use of acetaminophen during sensor wear period and the day prior to sensor insertion;
• Speak, read, and write English;
• Willing and able to be compliant with provisions laid out in this protocol.

You may not qualify if:

• 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;
• Allergy to medical-grade adhesives;
• Pregnant as demonstrated by a positive pregnancy test within 72 hours of sensor insertion,
• Dialysis treatment;
• Hematocrit that is outside the range of 30-55% at screening visit;

Sponsors & Collaborators

• DexCom, Inc.: lead

Study Sites (1)

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• David Price, MD

  DexCom, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2011
• First Posted: January 23, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 23, 2012

Record last verified: 2012-01

Locations

US (1)