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

This study has been completed.
Sponsor:
Information provided by:
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT01111370
First received: April 22, 2010
Last updated: January 17, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Diabetes Mellitus
Device: DexCom™ G4 Continuous Glucose Monitoring System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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:
  • Effectiveness and Safety Study of the DexCom G4 System [ Time Frame: August 2010 ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: February 2010
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CGM
continuous glucose monitoring system
Device: DexCom™ G4 Continuous Glucose Monitoring System
Continuous Glucose Monitoring System
Other Name: Continuous Glucose Monitoring System

Detailed Description:

This will be a non-randomized, single-armed study conducted in the United States. Following screening, a minimum of 60 to a maximum of 80 subjects at up to 4 clinical sites will be enrolled. All participants will wear the G4 Sensor for one 7-day wear period (~168 hours). A subset of 20-30 subjects will wear two G4 Systems (one of which will be blinded) during the 7-day wear period for the purposes of assessing precision. During home use, subjects will be asked to use the meter provided to them to take fingersticks for calibration and diabetes management. Subjects will also be asked to confirm high and low G4 System glucose alerts/alarms by taking a comparative fingerstick immediately after receiving an alert/alarm.

All subjects will participate in one, 8-hour in-clinic session on Day 1, 4, or 7 of the study to collect accuracy information against a laboratory standard (YSI) and against SMBG. During the in-clinic session, subjects will have venous blood draws for evaluation of the YSI blood glucose measurements. Carbohydrate consumption and insulin dosing may be manipulated during the in-clinic session to ensure a wide range of glucose values. For the duration of this study, subjects will be instructed to use G4 System information as an adjunct to (and not as a replacement for) standard SMBG guidance of diabetes self-management.

Subjects will perform G4 Sensor insertions at the clinic under supervision of study staff. Sensor insertion sites will be examined after removal of the Sensor(s). Study staff will document any irritation and/or Adverse Device Effects.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older;
  2. Have been diagnosed with insulin-requiring diabetes and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
  3. Willing not to inject insulin or wear an insulin pump insertion set within 3 inches from the Sensor site during Sensor wear;
  4. Willing to use only the blood glucose meter provided to them for self-monitoring of blood glucose (SMBG) during Sensor wear;
  5. 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;
  6. Willing to take a minimum of 6 fingersticks per day during home use (2 for calibration purposes, 4 for comparative purposes);
  7. Willing to refrain from the use of acetaminophen during the Sensor insertion period and for at least 24-hours prior to Sensor insertion;
  8. Willing not to schedule a magnetic resonance (MRI) scan, computed tomography (CT) scan, or x-ray, for the duration of the study;
  9. Able to speak, read, and write English.

Exclusion Criteria:

  1. 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;
  2. Subjects who have a known allergy to medical-grade adhesives;
  3. Are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion;
  4. Have a hematocrit that is less than 30%, or greater than 55%;
  5. 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);
  6. 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).
  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: NCT01111370

Sponsors and Collaborators
DexCom, Inc.
Investigators
Study Chair: Andrew Balo DexCom, Inc.
  More Information

No publications provided

Responsible Party: Andrew K Balo/SVP of Clinical and Regulatory Affairs, and Quality Assurance, DexCom
ClinicalTrials.gov Identifier: NCT01111370     History of Changes
Other Study ID Numbers: PTL900360
Study First Received: April 22, 2010
Last Updated: January 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by DexCom, Inc.:
diabetes mellitus requiring insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014