Diabetes Mellitus
Conditions
Brief summary
The objective of the study is to demonstrate effectiveness of the G6 sensor membrane, in preventing acetaminophen's interference effect on glucose sensing.
Detailed description
The interference effect of the sensor will be evaluated by comparing the bias in the glucose values exhibited from the G6 CGM system after administration of acetaminophen. Bias will be evaluated by comparing CGM values to a laboratory referenceusing venous sample measurements.
Interventions
DEVICEAcetaminophen Challenge (G6 CGM)
Evaluation of acetaminophen effect on CGM glucose sensing
Sponsors
DexCom, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
The system will be blinded to the user, i.e. no glucose values will be displayed to the subject during the study duration.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ages 18 or older * Diagnosis of diabetes
Exclusion criteria
* Pregnancy * Known gastroparesis * Abnormal liver function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interference Effect for the G6 CGM | 6 hrs post dose | Bias of sensor to reference measurement pre and post acetaminophen administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean of sensor minus YSI values (bias) for various time periods | 6 hrs post dose | Bias calculated for pre-dose, post dose and peak post dose |
| Duration of interference effect for the G6 CGM | 6 hrs post dose | Length of time the inhibition effect is more than 10 mg/dL |
Countries
United States
Outcome results
None listed