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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: Continuous Glucose Monitoring

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center for Childhood Diabetes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with type 1 diabetes mellitus

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
CGM System(s) performance (relative to YSI and/or SMBG) evaluated by standard accuracy metrics	15 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Documentation of all reported Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects	15 days

Collaborators and Investigators

• Sponsor: DexCom, Inc.

Publications and helpful links

General Publications

• 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: Diabetes Technol Ther. 2009 Mar;11(3):205.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: July 12, 2009
• First Submitted That Met QC Criteria: July 13, 2009
• First Posted (Estimate): July 14, 2009

Study Record Updates

• Last Update Posted (Estimate): February 3, 2010
• Last Update Submitted That Met QC Criteria: February 2, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Continuous glucose monitoring
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: PTL-900070, Rev01