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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Pilot Study of Concurrent Use of the SEVEN® and FreeStyle Navigator® Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939289
• Other study ID #: PTL-900070, Rev01
• Status: Completed
• Phase: N/A
• First received: July 12, 2009
• Last updated: February 2, 2010
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2010
• Source: DexCom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• Continuous Glucose Monitoring
Real-time continuous glucose monitoring with 2 commercially available Systems (DexCom SEVEN and Abbott Navigator)

Locations

Country	Name	City	State
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
DexCom, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Erratum in: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CGM System(s) performance (relative to YSI and/or SMBG) evaluated by standard accuracy metrics		15 days	No
Secondary	Documentation of all reported Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects		15 days	No