Effectiveness and Safety Study of the Next-Generation DexCom™ SEVEN® Continuous Glucose Monitoring System

This study has been completed.
Sponsor:
Information provided by:
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT00722241
First received: July 23, 2008
Last updated: July 24, 2008
Last verified: July 2008
  Purpose

The purpose of this study is to evaluate the safety and effectiveness of the next-generation DexCom SEVEN Continuous Glucose Monitoring System (SEVEN.2 System) when worn for up to 7-days by subjects >18 years-old with diabetes mellitus requiring insulin therapy.


Condition
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effectiveness and Safety Study of the Next-Generation DexCom™ SEVEN® Continuous Glucose Monitoring System

Resource links provided by NLM:


Further study details as provided by DexCom, Inc.:

Primary Outcome Measures:
  • SEVEN.2 System accuracy as compared to Yellow Springs Instrument (YSI) venous blood glucose measurements [ Time Frame: Days 1, 4, and 7 of Sensor wear ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: May 2008
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
A
Adult subjects (at least 18 years of age) with a diagnosis of type 1 diabetes (~80%) or insulin-treated type 2 diabetes (~20%); method of insulin delivery may be multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)

  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

Ambulatory (non-hospitalized) individuals with type 1 diabetes or insulin-treated type 2 diabetes selected from endocrinology clinics within the United States

Criteria

Inclusion Criteria:

  • 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(s) 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

Exclusion Criteria:

  • 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)
  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: NCT00722241

Locations
United States, California
John Muir Physician Network Clinical Research Center
Concord, California, United States, 94520
Advanced Metabolic Care + Research
Escondido, California, United States, 92026
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
DexCom, Inc.
Investigators
Study Chair: Andrew K Balo, BS DexCom, Inc.
  More Information

No publications provided

Responsible Party: Andrew K. Balo / SVP, Clinical and Regulatory Affairs, and Quality Assurance, DexCom, Inc.
ClinicalTrials.gov Identifier: NCT00722241     History of Changes
Other Study ID Numbers: PTL-300012, Rev01
Study First Received: July 23, 2008
Last Updated: July 24, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by DexCom, Inc.:
Continuous Glucose Monitoring
Interstitial Fluid
Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014