An Inpatient Performance Evaluation of a New Subcutaneous Glucose Sensor

NCT01112696 | Completed Results

• 1 other identifier: CEP 221
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of the study is to assess the performance of a new subcutaneous glucose sensor over a seven-day sensor life when used with currently marketed Medtronic Diabetes devices. In addition performance will be calculated for use of the new sensor with proposed new devices using new calibration algorithms.

Conditions

Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Keywords

diabetes; glucose sensor; CGM

Outcome Measures

Primary Outcomes (1)

• Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI): Proportion of Glucose Sensor Readings That Met Accuracy Criteria

  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

Study Arms (1)

Sensor

OTHER

All subjects that wear sensors (all subjects)

Device: Sensor wear

Interventions

Sensor wear DEVICE

All subjects to wear sensors

Also known as: Enlite Sensor

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
• Diagnosed with Type 1 or type 2 Diabetes Mellitus, using insulin to treat their diabetes (Each site's and overall study enrollment of subjects with Type 2 diabetes will target 20% of the total number)
• Willingness to perform required study and data collection procedures and to 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 CGMS iPro Systems
• Willingness to participate in a 10 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 14 days (\~340 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, Inc.

Escondido, California, 92026, United States

Location

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Rainier Clinical Research Center, Inc.

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

scott.w.lee@medtronic.com

818-576-4204

Study Officials

• Scott Lee, MD

  Medtronic Diabetes

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: April 28, 2010
• Study Start: April 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: January 16, 2018
• Results First Posted: August 27, 2012

Record last verified: 2017-12

Locations

US (3)