- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00722241
Effectiveness and Safety Study of the Next-Generation DexCom™ SEVEN® Continuous Glucose Monitoring System
July 24, 2008 updated by: DexCom, Inc.
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
53
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Concord, California, United States, 94520
- John Muir Physician Network Clinical Research Center
-
Escondido, California, United States, 92026
- Advanced Metabolic Care + Research
-
Santa Barbara, California, United States, 93105
- Sansum Diabetes Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Days 1, 4, and 7 of Sensor wear
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Andrew K Balo, BS, DexCom, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
July 23, 2008
First Submitted That Met QC Criteria
July 24, 2008
First Posted (Estimate)
July 25, 2008
Study Record Updates
Last Update Posted (Estimate)
July 25, 2008
Last Update Submitted That Met QC Criteria
July 24, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PTL-300012, Rev01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
AstraZenecaRecruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China