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

NCT ID: NCT00939289

Last Updated: 2010-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-02-28

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Continuous Glucose Monitoring

Intervention Type: DEVICE

Real-time continuous glucose monitoring with 2 commercially available Systems (DexCom SEVEN and Abbott Navigator)

Interventions

Continuous Glucose Monitoring

Real-time continuous glucose monitoring with 2 commercially available Systems (DexCom SEVEN and Abbott Navigator)

Intervention Type: DEVICE

Other Intervention Names

DexCom SEVEN; Abbott Navigator

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

DexCom, Inc.

Locations

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States

Countries

United States

References

Garg SK, Smith J, Beatson C, Lopez-Baca B, Voelmle M, Gottlieb PA. Comparison of accuracy and safety of the SEVEN and the Navigator continuous glucose monitoring systems. Diabetes Technol Ther. 2009 Feb;11(2):65-72. doi: 10.1089/dia.2008.0109.

Reference Type: RESULT

PMID: 19243265 (View on PubMed)

Garg SK, Voelmle M, Gottlieb PA. Time lag characterization of two continuous glucose monitoring systems. Diabetes Res Clin Pract. 2010 Mar;87(3):348-53. doi: 10.1016/j.diabres.2009.11.014.

Reference Type: DERIVED

PMID: 20022127 (View on PubMed)

Other Identifiers

PTL-900070, Rev01

Identifier Type: -

Identifier Source: org_study_id