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

This study has been completed.
Sponsor:
Information provided by:
DexCom, Inc.
ClinicalTrials.gov Identifier:
NCT00939289
First received: July 12, 2009
Last updated: February 2, 2010
Last verified: February 2010
  Purpose

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 Intervention
Type 1 Diabetes Mellitus
Device: Continuous Glucose Monitoring

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by DexCom, Inc.:

Primary Outcome Measures:
  • CGM System(s) performance (relative to YSI and/or SMBG) evaluated by standard accuracy metrics [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Documentation of all reported Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: July 2008
Study Completion Date: February 2009
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  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

Adults with type 1 diabetes mellitus

Criteria

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).
  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: NCT00939289

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrew K. Balo / SVP, Clinical and Regulatory Affairs, and Quality Assurance, DexCom, Inc.
ClinicalTrials.gov Identifier: NCT00939289     History of Changes
Other Study ID Numbers: PTL-900070, Rev01
Study First Received: July 12, 2009
Last Updated: February 2, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014