Table 6.
Advantages and Disadvantages of NIO-GM, NIFS-GM, or MI-GM Identified Products that were Cleared by the FDA or CE Marked (in Alphabetical Order Within Each Category of Invasiveness).
| Product and manufacturer | Degree of invasiveness | Advantages | Disadvantages |
|---|---|---|---|
| GlucoTrack; Integrity Applications Ltd | NIO-GM | - Uses a blend of 3 optical technologies. | - Ear measurement site can be inconvenient |
| TensorTip Combo Glucometer; Cnoga Medical Ltd | NIO-GM | - Portable | - Not wearable |
| - Requires regular recalibration | |||
| sugarBEAT; Nemaura Medical | NIFS-GM | - Uses a well-tolerated adhesive | - No PubMed published data. |
| - Skin ISF is measured without puncturing the skin. - You can wear the device on any single day and not have to wear it on multiple consecutive days. |
- Reverse iontophoresis irritated the skin in a similar product from a different manufacturer: GlucoWatch | ||
| - The accuracy has not been established if a patient is sweating, or if there are rapid changes in the blood glucose concentration. | |||
| - There should be good correlation between glucose level in the ISF and in the blood under stable conditions. | |||
| - Glucose measurement is based on the well-known enzymatic method. | |||
| Cascade CGM System; Waveform | MI-GM | - Accurate
152
- 14-day duration - Automatic data uploading - Inserts without a needle - Audible glucose alarms - Software identifies glucose patterns |
- Point accuracy of MI-GMs that measure ISF is less than point accuracy of blood glucose monitors that use capillary blood as a comparator matrix. |
| - Some patients do not want to carry an inserted or implanted device on their body at all times. | |||
| - No CGM is labeled to allow for exposure to radiation. | |||
| - Sometimes allergic dermatitis due to adhesive | |||
| CT-100; POCTech X Ascensia | MI-GM | - CT-100 features a 4-electrode system. In addition to a glucose sensing electrode, it features a dedicated blank electrode that monitors background and electrochemical interferences. It enables real time correction of any background drift and interference. | - Point accuracy of MI-GMs that measure ISF is less than point accuracy of blood glucose monitors that use capillary blood as a comparator matrix. - Some patients do not want to carry an inserted or implanted device on their body at all times. - No CGM is labeled to allow for exposure to radiation. |
| - CT-100 sensor is built on a flexible polyimide matrix. It is one of the most flexible sensors available. This provides higher level comfort for 24/7 wearing. | |||
| - CT-100 sensor features an all planar design and align electrodes on both sides of the matrix. It can fully utilize currently available industrial manufacturing techniques for mass production, and therefore provides a potential for a favorable cost effectiveness and easier quality control. | |||
| Dexcom G6; Dexcom | MI-GM | - Accurate
159
- 10-day duration - Automatic data uploading with sharing feature - Factory calibration - Audible glucose alarms - Software identifies glucose patterns |
- Point accuracy of MI-GMs that measure ISF is less than point accuracy of blood glucose monitors that use capillary blood as a comparator matrix. |
| - Some patients do not want to carry an inserted or implanted device on their body at all times. | |||
| - No CGM is labeled to allow for exposure to radiation. | |||
| - Sometimes allergic dermatitis due to adhesive | |||
| Eversense; Senseonics | Implanted (MI-GM) | - Accurate
263
- 90-180 day duration- Automatic data uploading with sharing feature - Removable transmitter - Audible and vibratory glucose alarms - Software identifies glucose patterns |
- Point accuracy of MI-GMs that measure ISF is less than point accuracy of blood glucose monitors that use capillary blood as a comparator matrix. |
| - Some patients do not want to carry an inserted or implanted device on their body at all times. | |||
| - No CGM is labeled to allow for exposure to radiation. | |||
| - Possible difficulty removing a chronically implanted sensor. | |||
| FreeStyle Libre 14 day; Abbott Diabetes Care | MI-GM | - Accurate267,343,344 - 14-day duration 343 - No separate transmitter; on demand data with sharing feature - Factory calibration - Software identifies glucose patterns |
- Point accuracy of MI-GMs that measure ISF is less than point accuracy of blood glucose monitors that use capillary blood as a comparator matrix. |
| - Some patients do not want to carry an inserted or implanted device on their body at all times. | |||
| - No CGM is labeled to allow for exposure to radiation | |||
| - Patient must actively perform an action to determine glucose levels | |||
| - System cannot be calibrated - no optional user calibration in cases of sensor inaccuracy | |||
| - Sometimes allergic dermatitis due to adhesive | |||
| - No hypoglycemia alarm | |||
| FreeStyle Libre 2; Abbott Diabetes Care | MI-GM | - Accurate
269
- 14-day duration 269 - No separate transmitter; on demand data with sharing feature - Factory calibration - Audible glucose alarms - Software identifies glucose patterns |
- Point accuracy of MI-GMs that measure ISF is less than point accuracy of blood glucose monitors that use capillary blood as a comparator matrix. |
| - Some patients do not want to carry an inserted or implanted device on their body at all times. | |||
| - No CGM is labeled to allow for exposure to radiation | |||
| - Patient must actively perform an action to determine glucose levels | |||
| - System cannot be calibrated - no optional user calibration in cases of sensor inaccuracy | |||
| - Sometimes allergic dermatitis due to adhesive | |||
| FreeStyle Libre 3; Abbott Diabetes Care | MI-GM | - The FreeStyle Libre 3 system is designed to automatically deliver accurate real-time, up-to-the-minute glucose readings,
345
and optional glucose alarms directly to smartphones - Designed to be the smallest and thinnest wearable glucose sensor. - Users can view their glucose levels anytime - Designed to have the same performance as the FreeStyle Libre 2 sensor, but with a new sensor design and at the same price as previous versions |
- Point accuracy of MI-GMs that measure ISF is less than point accuracy of blood glucose monitors that use capillary blood as a comparator matrix. |
| - Some patients do not want to carry an inserted or implanted device on their body at all times. | |||
| - No CGM is labeled to allow for exposure to radiation | |||
| - System cannot be calibrated - no optional user calibration in cases of sensor inaccuracy | |||
| - Sometimes allergic dermatitis due to adhesive | |||
| Glucomen Day CGM; Menarini Diagnostics | MI-GM | - Does not require any needles for insertion - Promoted as eco-friendly 180 - Transmitter can last 3 years 346 |
- Point accuracy of MI-GMs that measure ISF is less than point accuracy of blood glucose monitors that use capillary blood as a comparator matrix. |
| - Some patients do not want to carry an inserted or implanted device on their body at all times. | |||
| - No CGM is labeled to allow for exposure to radiation | |||
| Glunovo i3 CGM; Infinovo | MI-GM | - Point accuracy of MI-GMs that measure ISF is less than point accuracy of blood glucose monitors that use capillary blood as a comparator matrix. | |
| - Some patients do not want to carry an inserted or implanted device on their body at all times. | |||
| - No CGM is labeled to allow for exposure to radiation | |||
| Medtronic Guardian Connect (Powered by Medtronic Guardian Sensor 3); Medtronic MiniMed | MI-GM | - Accurate
281
- 7-day duration - Automatic data uploading - Audible glucose alarms - Software developed with IBM identifies glucose patterns |
- Point accuracy of MI-GMs that measure ISF is less than point accuracy of blood glucose monitors that use capillary blood as a comparator matrix. |
| - Some patients do not want to carry an inserted or implanted device on their body at all times. | |||
| - No CGM is labeled to allow for exposure to radiation | |||
| - Sometimes allergic dermatitis due to adhesive | |||
| - There is a need to calibrate twice a day with a blood glucose measurement | |||
| - Wear time (7 days) shorter than some other products |
Abbreviations: AID, automated insulin delivery; CGM, continuous glucose monitor; IBM, International Business Machines Corporation; iCGM, integrated continuous glucose monitor; ISF, interstitial fluid; MI-GM, minimally invasive glucose monitor; NIFS-GM, noninvasive fluid sensing glucose monitor; NIO-GM, noninvasive glucose monitor.