An Inpatient Evaluation of Six-Day Subcutaneous Glucose Sensor Performance

NCT00865345 | Completed Results DMC

• 1 other identifier: CEP 218
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to assess the performance of the subcutaneous glucose sensor over an extended sensor life. The sensor is currently approved for 3 days of use and this study will examine sensor safety and accuracy when used for six days. This study will also test sensor safety and accuracy when inserted in an alternate body location (buttock area in addition to abdomen area). The study hypothesis is that the sensor performance will not greatly diminish when used for six days, or in an alternate insertion area.

Conditions

Diabetes

Keywords

blood sugar; glucose; sensor

Outcome Measures

Primary Outcomes (1)

• Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI-Yellow Springs Instruments)

  The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI \<80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.

  Days one through six of sensor use

Secondary Outcomes (1)

• Device Related Moderate or Device Related Severe Adverse Events

  days one through six of sensor wear

Interventions

MMT-7003 subcutaneous glucose sensor DEVICE

All subjects will use the glucose sensor, randomized to participate in a 12-hour frequent (15-minute) blood glucose sampling period on one of six days of sensor wear. Blood samples will be analyzed using a laboratory standard (YSI) for comparison to the glucose sensor to evaluate accuracy.

Also known as: Glucose sensor, Blood sugar sensor, glucose monitor, blood sugar monitor, MiniMed sensor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females aged 18 through 75 inclusive
• Type 1 Diabetes Mellitus treated using either CSII (continuous subcutaneous insulin infusion) or MDI (multiple daily injections) for a minimum of 3 months
• Willingness to perform required study and data collection procedures and adhere to operating requirements of the Guardian REAL-Time and CGMS iPro Systems
• Willingness to perform at least 4 capillary blood glucose tests per day while wearing the Guardian REAL-Time and iPro Systems
• Willing to participate in a 12 hour frequent blood sampling session during the study
• Subject agrees to comply with the study protocol requirements
• Informed Consent, HIPAA Authorization, and California Experimental Subject Bill of Rights (if applicable) signed by the subject
• The Subject is willing to wear both the Guardian REAL-Time and CGMS iPro Systems for 6 days (\~144 hours).

You may not qualify if:

• The Subject has a history of tape allergies that have not been resolved
• The Subject has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) that has not been resolved and would inhibit them from wearing the sensors
• Subject is currently participating in an investigational study (drug or device)

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (3)

AMCR Institute

Escondido, California, 92026, United States

Location

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Scott Lee M.D.
• Organization: Medtronic

scott.w.lee@medtronic.com

818-576-4204

Study Officials

• John Mastrototaro, PHD

  Medtronic Diabetes

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2009
• First Posted: March 19, 2009
• Study Start: March 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: November 6, 2012
• Results First Posted: August 27, 2012

Record last verified: 2012-11

Locations

US (3)