This is a single center, single arm non-randomized study of 48-hour CGMIS wear duration incorporating two meal-challenge tests to explore the performance of a single insertion combined glucose-sensing insulin delivery cannula.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
An integrated combination CGM/insulin infusion system
Rainier Clinical Research Center
Renton, Washington, United States
RECRUITINGAccuracy
Sensor accuracy as determined by mean absolute difference (MAD) for reference YSI venous blood glucose values ≤75 mg/dL and mean absolute relative difference (MARD) for reference YSI venous blood glucose values \>75 mg/dL
Time frame: First 48 hours
Accuracy
• Sensor accuracy in the performance metrics described in the FDA iCGM Special Controls.
Time frame: First 48 hours
Number of subjects who discontinue delivery of insulin through the device due to unexplained hyperglycemia
this will be the number of subjects who experience unexplained glycemic excursions requiring a cannula change
Time frame: First 48 hours
Results of tolerability questionnaire
A tolerability questionnaire will assess level of discomfort (none to severe), and duration.
Time frame: First 48 hours
Results of Draize scale
Draize scale will be used by study staff to evaluate the presence and severity of erythema and edema at the site of device use after removal.
Time frame: Firts 48 hours
Visual Analog Scale (VAS) for site discomfort
Subject will place a mark along a 100mm line to denote visually their perceived intensity of discomfort. Results will range from no discomfort to worst possible discomfort.
Time frame: First 48 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.