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| Management number | 203240216 | Release Date | 2025/09/24 | List Price | $67.00 | Model Number | 203240216 | ||
|---|---|---|---|---|---|---|---|---|---|
| Category | |||||||||
Intermittent scanning CGM for diabetes self-management. Measures glucose levels in interstitial fluid via a small sensor placed on the back of the upper arm. Glucose data is displayed when the sensor is scanned with the reader.
14-Day Wear – Sensor lasts up to two weeks without calibration.
Factory-Calibrated – No fingerstick calibration required.
Trend Data – Displays 8-hour glucose history and trend arrows.
Quick Scanning – Get results in seconds by scanning the sensor with the reader or compatible device.
Discreet & Comfortable – Slim, water-resistant sensor can be worn during everyday activities.
| Specification | Details |
|---|---|
| Type | Flash Glucose Monitoring System (Intermittent Scanning CGM) |
| Sensor Placement | Posterior upper arm |
| Wear Duration | Up to 14 days |
| Calibration | Factory calibrated – no SMBG calibration needed |
| Alarms | None (scan to view readings) |
| Trend Display | 8-hour glucose history |
| Accuracy | Mean Absolute Relative Difference: 11.4% (adults), 13.9% (children) |
| FDA Approval Year | 2017 |
| Water Resistance | Yes, up to 1 meter for 30 minutes |
Accuracy: Stable over 14 days; slightly reduced during hypoglycemia, post-glucose load, and exercise.
Glycemic Impact:
Systematic review (n=2,477) found CGMs improved time in range by ~70 min/day and reduced hypo- and hyperglycemia compared to SMBG.
Meta-analysis (n=2,173) found A1C reduction of −0.26% from baseline; not statistically significant compared with SMBG.
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