Concurrent Use of Two Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes Mellitus (T1DM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00939289
Recruitment Status : Completed
First Posted : July 14, 2009
Last Update Posted : February 3, 2010
Information provided by:
DexCom, Inc.

Brief Summary:
The purpose of this pilot study is to evaluate performance of the SEVEN System and the Navigator System when both devices are worn concurrently by subjects with type 1 diabetes mellitus.

Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Device: Continuous Glucose Monitoring

Study Type : Observational
Actual Enrollment : 14 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of Concurrent Use of the SEVEN® and FreeStyle Navigator® Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes Mellitus
Study Start Date : July 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
Adults with T1DM
Adults (18+ years-old) diagnosed with type 1 diabetes mellitus; treated with multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy
Device: Continuous Glucose Monitoring
Real-time continuous glucose monitoring with 2 commercially available Systems (DexCom SEVEN and Abbott Navigator)
Other Names:
  • DexCom SEVEN
  • Abbott Navigator

Primary Outcome Measures :
  1. CGM System(s) performance (relative to YSI and/or SMBG) evaluated by standard accuracy metrics [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. Documentation of all reported Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects [ Time Frame: 15 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults with type 1 diabetes mellitus

Inclusion Criteria:

  1. Age 18 years or older;
  2. Have been diagnosed with type 1 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 infusion set within 3 inches from either Sensor site;
  4. Willing to participate in an 8-hour in-clinic session on study Days 5, 10, and 15 and be willing to take 4 fingersticks per hour and have 4 blood draws per hour for the 8-hour duration of each of these in-clinic sessions;
  5. Willing to take a minimum of 6 fingersticks per day during home use;
  6. Willing to refrain from the use of acetaminophen during this study and for at least 24-hours prior to enrollment;
  7. Willing not to schedule an magnetic resonance (MRI) scan, computed tomography (CT) scan, x-ray, for the duration of the study;
  8. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00939289

United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
DexCom, Inc.

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Andrew K. Balo / SVP, Clinical and Regulatory Affairs, and Quality Assurance, DexCom, Inc. Identifier: NCT00939289     History of Changes
Other Study ID Numbers: PTL-900070, Rev01
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: February 3, 2010
Last Verified: February 2010

Keywords provided by DexCom, Inc.:
Continuous glucose monitoring

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