New Glucose Sensor Pediatric

NCT01161043 | Completed Results

• 1 other identifier: CEP232
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetes; glucose; sensor

Outcome Measures

Primary Outcomes (1)

• Glucose Sensor Accuracy When Compared to SMBG: Proportion of Glucose Sensor Readings That Met Accuracy Criteria [Time Frame: Days One Through Six of Sensor Use]

  The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and SMBG glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between SMBG and paired sensor (within 20 mg/dL if SMBG ≤ 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

EXPERIMENTAL

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: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Males and females aged 7 through 17 inclusive
• Diagnosed with Type 1 Diabetes Mellitus
• Willingness to perform required study and data collection procedures and to adhere to operating requirements of the Guardian REAL-TIME System
• Willingness to perform at least 4 capillary blood glucose tests per day while wearing the Guardian REAL-TIME System
• Subject agrees to comply with the study protocol requirements
• Informed Consent, Assent, HIPAA Authorization, and California Experimental Subject Bill of Rights (if applicable) signed by the subject and/or parent/guardian
• The Subject is willing to wear the Guardian REAL-Time System for 14 days (\~340 hours).

You may not qualify if:

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

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (4)

University of Alabama Birmingham

Birmingham, Alabama, 35213, United States

Location

Sutter Institute for Medical Research

Sacramento, California, 95816, United States

Location

Endocrinology/ University of South Florida

St. Petersburg, Florida, 33549, United States

Location

University of Minnesota Amplatz Children's Hospital

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; 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: Suiying Huang
• Organization: Medtronic Diabetes

suiying.huang@medtronic.com

8185763319

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: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2010
• First Posted: July 13, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 4, 2020
• Results First Posted: September 4, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)