Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices

• Sponsor: Medtronic Diabetes (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04020822
• Collaborator: (none)
• Enrollment: 19
• Locations: 2
• Arm: 1
• Actual Duration (Days): 29
• Patients Per Site: 9.5
• Patients Per Site Per Month: 10

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes; Type 2 Diabetes	Device: Guardian Sensor (3)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 19 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices - Phase 3 Group
• Actual Study Start Date: Jul 29, 2019
• Actual Primary Completion Date: Aug 27, 2019
• Actual Study Completion Date: Aug 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: Guardian Sensor (3); Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.

Outcome Measures

Primary Outcome Measures

1. Accuracy of Sensor Glucose Before and After Acetaminophen Administration [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]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Barbara Davis Center for Diabetes	Aurora	Colorado	United States	80045
2	Atlanta Diabetes Associates	Atlanta	Georgia	United States	30318

Sponsors and Collaborators

• Medtronic Diabetes

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jun 21, 2019
• Statistical Analysis Plan - Jul 30, 2019

More Information

Publications

None provided.

• Responsible Party: Medtronic Diabetes
• ClinicalTrials.gov Identifier: NCT04020822
• Other Study ID Numbers: CIP318
• First Posted: Jul 16, 2019
• Last Update Posted: Sep 16, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Medtronic Diabetes: Acetaminophen
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

Participant Flow

Arm/Group Title	Subjects Wearing Guardian Sensor (3)s
Arm/Group Description	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. Guardian Sensor (3): Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.
Period Title: Overall Study
STARTED	19
COMPLETED	19
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Subjects Wearing Guardian Sensor (3)s
Arm/Group Description	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. Guardian Sensor (3): Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.
Overall Participants	19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.9 (13.5)
Sex: Female, Male (Count of Participants)
Female	14 73.7%
Male	5 26.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	19 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 10.5%
White	17 89.5%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	19 100%

Outcome Measures

1. Primary Outcome

Title	Accuracy of Sensor Glucose Before and After Acetaminophen Administration
Description	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).
Time Frame	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

Outcome Measure Data

Analysis Population Description

Only data from 13 subjects were evaluated due to data loss.

Arm/Group Title	Subjects Wearing Guardian Sensor (3)s
Arm/Group Description	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. Guardian Sensor (3): Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.
Measure Participants	13
(-1, 0] hour of Acetaminophen Ingestion	9.46 (4.63)
(0, 1] hour of Acetaminophen Ingestion	12.02 (6.53)
(1, 2] hour of Acetaminophen Ingestion	16.98 (10.96)

Adverse Events

Time Frame	11 Days
Arm/Group Title	Subjects Wearing Guardian Sensor (3)s
Arm/Group Description	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. Guardian Sensor (3): Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.
All Cause Mortality
	Subjects Wearing Guardian Sensor (3)s
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Serious Adverse Events
	Subjects Wearing Guardian Sensor (3)s
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Other (Not Including Serious) Adverse Events
	Subjects Wearing Guardian Sensor (3)s
	Affected / at Risk (%)	# Events
Total	0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.