Type 1 Diabetes, Type 2 Diabetes
Conditions
Keywords
Acetaminophen
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.
Interventions
DEVICEGuardian Sensor (3)
Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.
Sponsors
Medtronic Diabetes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Guardian Sensor (3): Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter. | 19 |
| Total | 19 |
Baseline characteristics
| Characteristic | Subjects Wearing Guardian Sensor (3)s |
|---|---|
| Age, Continuous | 31.9 years STANDARD_DEVIATION 13.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 0 / 19 |
| serious Total, serious adverse events | 0 / 19 |
Outcome results
Primary
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).
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
Population: Only data from 13 subjects were evaluated due to data loss.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects Wearing Guardian Sensor (3)s | Accuracy of Sensor Glucose Before and After Acetaminophen Administration | (-1, 0] hour of Acetaminophen Ingestion | 9.46 Percent | Standard Deviation 4.63 |
| Subjects Wearing Guardian Sensor (3)s | Accuracy of Sensor Glucose Before and After Acetaminophen Administration | (0, 1] hour of Acetaminophen Ingestion | 12.02 Percent | Standard Deviation 6.53 |
| Subjects Wearing Guardian Sensor (3)s | Accuracy of Sensor Glucose Before and After Acetaminophen Administration | (1, 2] hour of Acetaminophen Ingestion | 16.98 Percent | Standard Deviation 10.96 |