Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices

NCT ID: NCT04020822

Last Updated: 2020-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-29
• Study Completion Date: 2019-08-27

Brief Summary

The purpose of Phase 3 Group is to evaluate the impact of acetaminophen on the performance of Guardian Sensor (3) during 11 days of wear (approximately 264 hours) in subjects with insulin requiring diabetes,18-75 years of age.

Detailed Description

The study is a multi-center, prospective single-arm design without controls. All subjects will be assigned to treatment for 11 days of sensor wear. Each subject will wear 4 Guardian Sensor (3)s, and each will be connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter. Subjects will not use sensor glucose values for diabetes management.

On days 1, 3, 5, and 6, subjects will be asked to measure blood glucose (BG) using a home glucose meter approximately every 20 minutes for 5 hours. Subjects will be asked to take one gram of acetaminophen orally on days 3, 5, and 6 of sensor wear.

On day 11, devices will be removed, data uploaded from the study meter and transmitter or recorder, skin assessment will be performed, and the subject's participation in the study will be completed.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Subjects Wearing Guardian Sensor (3)s

Each subject will wear 4 Guardian Sensor (3)s connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter for 11 days of sensor wear.

Group Type: EXPERIMENTAL

Guardian Sensor (3)

Intervention Type: DEVICE

Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.

Interventions

Guardian Sensor (3)

Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is 18-75 years of age at time of screening

2. A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator, for at least the last 12 months

3. Subject is using insulin to treat their diabetes

4. Subject agrees to comply with the study protocol requirements

5. Subject is willing to perform self-monitoring of blood glucose approximately every 20 minutes during FST

Exclusion Criteria

1. Subject has history of allergy to acetaminophen or has been told by health care provider they may not ingest acetaminophen

2. Subject reports history of liver cirrhosis or problems with liver that a health care provider told them they should not use acetaminophen because of liver disorder.

3. Subject is unable to tolerate tape adhesive in the area of sensor placement

4. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)

5. Subject is actively participating in or plans to enroll in an investigational study (drug or device), other than this study, wherein they have received treatment from an investigational drug or device

6. Subject has a positive urine pregnancy test at time of screening

7. Subject is female, sexually active without the use of contraception, able to become pregnant or plans to become pregnant during the course of the study

8. Subject is unwilling to participate in study procedures.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Barbara Davis Center for Diabetes

Aurora, Colorado, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CIP318

Identifier Type: -

Identifier Source: org_study_id