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

NCT01111370 | Completed Results

• 1 other identifier: PTL900360
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of the G4 System when worn for up to 7-days by subjects \>18 years-old with diabetes mellitus requiring insulin. Device performance will be primarily evaluated in terms of 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 meter glucose levels \<80 mg/dL. These G4-YSI matched pairs will be collected during in-clinic sessions on Days 1, 4, and 7 of Sensor wear. The proportion of matched pairs from this study (PTL-900360) meeting the above criteria will be compared to the proportion of such points observed in the DexCom clinical study that supported approval of the SEVEN PLUS System (PTL 300012). Safety data of the G4 System will also be collected and safety will be characterized by the incidence of Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects experienced by study participants.

Conditions

Diabetes Mellitus

Keywords

diabetes mellitus requiring insulin

Outcome Measures

Primary Outcomes (1)

• the Proportion of G4 CGM System in Agreement With the Reference Standard

  The proportion of G4 System values within (±) 20% of YSI reference value for glucose levels \>80 mg/dL and (±) 20 mg/dL at YSI glucose levels \<80 mg/dL. This is primarayly laboratory measurement outcome,and it is not measured by clinical outcome, for example, diagnosis, treatement and complication, and clinical effectiveness, etc.

  Assessment done on either Day 1, 4 or 7 of the sensor wear period

Study Arms (1)

CGM

EXPERIMENTAL

continuous glucose monitoring system

Device: DexCom™ G4 Continuous Glucose Monitoring System

Interventions

DexCom™ G4 Continuous Glucose Monitoring System DEVICE

Continuous Glucose Monitoring System

Also known as: Continuous Glucose Monitoring System

CGM

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older;
• Have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
• Willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the Sensor site during Sensor wear;
• Willing to use only the blood glucose meter provided to them for self-monitoring of blood glucose (SMBG) during Sensor wear;
• Willing to participate in one, 8-hour in-clinic session and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the entire 8-hour duration;
• Willing to take a minimum of 6 fingersticks per day during home use (2 for calibration purposes, 4 for comparative purposes);
• Willing to refrain from the use of acetaminophen during the Sensor insertion period and for at least 24-hours prior to Sensor insertion;
• Willing not to schedule a magnetic resonance (MRI) scan, computed tomography (CT) scan, or x-ray, for the duration of the study;
• Able to speak, read, and write English.

You may not qualify if:

• Have extensive skin changes/diseases that preclude wearing the Sensor 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;
• Subjects who have a known allergy to medical-grade adhesives;
• Are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion;
• Have a hematocrit that is less than 30%, or greater than 55%;
• Current participation 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 any condition that, in the opinion of the Investigator, would interfere with their participation in the trial or pose an excessive risk to study staff handling venous blood samples (e.g., known history of hepatitis B or C).

Sponsors & Collaborators

• DexCom, Inc.: lead

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Results Point of Contact

• Title: Andy Balo/Sr. VP
• Organization: Dexcom, Inc

abalo@dexcom.com

8582000203

Study Officials

• Andrew Balo

  DexCom, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 27, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: March 27, 2017
• Results First Posted: March 27, 2017

Record last verified: 2015-08

Data Sharing

• IPD Sharing: Will not share