Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices

NCT04020822 | Completed Results FDA Device

• 1 other identifier: CIP318
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

Acetaminophen

Outcome Measures

Primary Outcomes (1)

• Accuracy of Sensor Glucose Before and After Acetaminophen Administration

  Accuracy (mean absolute relative difference) between the primary sensor values and meter BG values during the hour leading to and two hours after ingestion of acetaminophen. Primary sensor will be assigned to sensor number one (inserted in arm). Mean Absolute Relative Difference = Mean of ((absolute difference of meter and sensor blood glucose values / meter glucose values) \* 100). Note that the results reported below for one hour leading to and two hours after acetaminophen ingestion were pooled together across multiple testing days (days 3, 5, and 6).

  Assessed up to 11 days, frequent sample testing recordings from the three-hour period leading to and after Acetaminophen ingestion on days 3, 5, and 6 reported

Study Arms (1)

Subjects Wearing Guardian Sensor (3)s

EXPERIMENTAL

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.

Device: Guardian Sensor (3)

Interventions

Guardian Sensor (3) DEVICE

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

Subjects Wearing Guardian Sensor (3)s

Eligibility Criteria

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

You may qualify if:

• Subject is 18-75 years of age at time of screening
• A clinical diagnosis of type 1 or type 2 diabetes as determined by investigator, for at least the last 12 months
• Subject is using insulin to treat their diabetes
• Subject agrees to comply with the study protocol requirements
• Subject is willing to perform self-monitoring of blood glucose approximately every 20 minutes during FST

You may not qualify if:

• Subject has history of allergy to acetaminophen or has been told by health care provider they may not ingest acetaminophen
• 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.
• Subject is unable to tolerate tape adhesive in the area of sensor placement
• Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g. psoriasis, rash, Staphylococcus infection)
• 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
• Subject has a positive urine pregnancy test at time of screening
• 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
• Subject is unwilling to participate in study procedures.

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (2)

Barbara Davis Center for Diabetes

Aurora, Colorado, 80045, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Kusal Ahangama, Clinical Study Manager
• Organization: Medtronic Diabetes

kusal.c.ahangama@medtronic.com

+18185765023

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 12, 2019
• First Posted: July 16, 2019
• Study Start: July 29, 2019
• Primary Completion: August 27, 2019
• Study Completion: August 27, 2019
• Last Updated: September 16, 2020
• Results First Posted: September 16, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)