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

NCT00939289 | Completed

• 1 other identifier: PTL-900070, Rev01
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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

Keywords

Continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• CGM System(s) performance (relative to YSI and/or SMBG) evaluated by standard accuracy metrics

  15 days

Secondary Outcomes (1)

• Documentation of all reported Adverse Device Effects, Serious Adverse Device Events, and Unanticipated Adverse Device Effects

  15 days

Study Arms (1)

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

Interventions

Continuous Glucose Monitoring DEVICE

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

Also known as: DexCom SEVEN, Abbott Navigator

Adults with T1DM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with type 1 diabetes mellitus

You may qualify if:

• Age 18 years or older;
• Have been diagnosed with type 1 diabetes and are on multiple daily injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) insulin therapy;
• Willing not to inject insulin or wear an insulin pump infusion set within 3 inches from either Sensor site;
• 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;
• Willing to take a minimum of 6 fingersticks per day during home use;
• Willing to refrain from the use of acetaminophen during this study and for at least 24-hours prior to enrollment;
• Willing not to schedule an magnetic resonance (MRI) scan, computed tomography (CT) scan, x-ray, for the duration of the study;
• Able to speak, read, and write English.

You may not qualify if:

• 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;
• Subjects who have a known allergy to medical-grade adhesives;
• Are pregnant as demonstrated by a positive pregnancy test within 72 hours of insertion;
• Have a hematocrit that is less than 30%, or greater than 55%;
• 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);
• 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).

Sponsors & Collaborators

• DexCom, Inc.: lead

Study Sites (1)

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• 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.

  PMID: 19243265 RESULT

• 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.

  PMID: 20022127 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 12, 2009
• First Posted: July 14, 2009
• Study Start: July 1, 2008
• Primary Completion: August 1, 2008
• Study Completion: February 1, 2009
• Last Updated: February 3, 2010

Record last verified: 2010-02

Locations

US (1)