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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00722241 |
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Date of registration:
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23/07/2008 |
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Primary sponsor: |
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Public title:
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Effectiveness and Safety Study of the Next-Generation DexCom™ SEVEN® Continuous Glucose Monitoring System
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Scientific title:
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Effectiveness and Safety Study of the Next-Generation DexCom™ SEVEN® Continuous Glucose Monitoring System |
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Date of first enrolment:
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May 2008 |
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Target sample size:
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53 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00722241 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Countries of recruitment
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United States
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Contacts
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Name:
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Andrew K Balo, BS |
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Address:
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Telephone:
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Email:
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Affiliation:
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DexCom, Inc. |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 1
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Diabetes Mellitus, Type 2
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Primary Outcome(s)
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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]
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Secondary ID(s)
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PTL-300012, Rev01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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