Technical Data

Product Name

Accu-Chek SmartGuide device

Transport and Storage

Transport and storage conditions of the sensor in its unopened packaging:

  • Temperature range: 2 to 27 °C
  • Humidity range: 10 to 90 % (non-condensing)
  • Air pressure range: 549 to 1060 hPa

  • Make sure that you only store unopened products. Insert the sensor immediately after opening the packaging.

Operating Conditions

  • Temperature range: 10 to 40 °C
  • Humidity range: 15 to 90 % (non-condensing, water vapor partial pressure less than 50 hPa)
  • Air pressure range: 700 to 1060 hPa
  • Maximum altitude: 3000 m (9842 ft)

The time to warm up the CGM device from lowest storage temperature (2 °C) to lowest operating temperature (10 °C) is less than 17 minutes.

The surface temperature of the sensor will remain below 43 °C and will only exceed 41 °C for a limited time.

Interfering Substances

Taking the following interfering substances while wearing the sensor may falsely raise CGM values displayed in the app:

  • Ascorbic acid (vitamin C): more than 500 mg / day orally, or any amount intravenously
  • Supplements with gentisic acid
  • Methyldopa

Falsely raised CGM values can lead to insulin overdosing and can cause you to miss an occurrence of very low glucose. If you are taking any of the listed interfering substances, consult your healthcare professional.

Operating Principle

The continuous glucose monitoring (CGM) device consists of an applicator and a sensor. The applicator is discarded after use, while the sensor remains on the skin, with its electrochemical sensor inserted subcutaneously. An electronic component processes sensor data and facilitates communication.

The sensor connects to an app, which serves as the primary display and receiver of data. During calibration, blood glucose values are entered into the app and sent to the sensor. The sensor then measures glucose levels in the interstitial fluid and sends this data to the app every 5 minutes.

Sensor Dimensions

Height (incl. adhesive pad)

approx. 5.9 mm

Needle length

approx. 8.2 mm

Diameter of sensor without adhesive pad

approx. 33.3 mm

Weight

approx. 5 g

Data Transfer

The sensor transfers the following data to the app:

  • Serial number
  • Firmware version
  • Hardware version
  • Sensor information (System ID / MAC address)
  • Time for next calibration
  • CGM values
  • Status information

CGM values generated while the sensor is in Trend Mode are indicated by the Sensor Status Annunciation-Bit 'Calibration required'.

Communication Interface

Purpose of interface

Communication interface. Allows the sensor to exchange data with a mobile device.

Interface specification

Bluetooth® Low Energy 5.0 or higher

Frequency band of radio frequency reception and transmission

Bluetooth® Low Energy 5.0: 2.402–2.480 GHz

Type and frequency characteristics of the modulation

GFSK (Gaussian Frequency-Shift Keying)

Effective radiated power of transmission

Less than 10 mW

Method of time synchronization

The sensor synchronizes according to the synchronization intervals of the mobile device.

Bluetooth® Low Energy range

10 m

Access to Bluetooth® Low Energy connection with mobile device

On the mobile device, Bluetooth® Low Energy technology must be turned on for establishing a connection.

Radio frequency interferences

Communication may be affected by other radio frequency devices.

Electromagnetic Compatibility (EMC)

All EMC tests were carried out in accordance with the IEC 60601-1-2:2014, IEC 60601-1-2:2014/AMD1:2020 standard.

 
WARNING
Risk of interference

Electromagnetic fields and electromagnetic radiation may interfere with the proper operation of the sensor, resulting in incorrect CGM values. The sensor can influence other equipment (for example, through transmitted Bluetooth® signals) if it is used outside its technical specifications. Only use the sensor within its technical specifications.

 
WARNING
Risk of malfunction

Don’t place other devices close to or on top of the sensor. Use of the sensor alongside or with other devices may result in incorrect operation. If such use is necessary, observe the sensor and the other devices. Verify that the sensor and the other devices are operating as intended.

Don’t bring portable radio frequency communication devices (including peripherals such as antenna cables and external antennas) closer than 30 cm (12 inches) to the sensor. This may affect the performance of the sensor.

Electromagnetic Emissions

The sensor complies with the following Emissions Standards.

Radiated RF emission according to:

  • CISPR 11 (EN 55011) class B, group 1
  • RTCA DO160G Section 21, category M for in-cabin use

Electromagnetic Immunity

The sensor complies with the following immunity standards and immunity test levels.

Electrostatic discharge (IEC 61000-4-2), test level:

  • Contact: ±2 kV, ±4 kV, ±6 kV, ±8 kV
  • Air: ±2 kV, ±4 kV, ±8 kV, ±15 kV

Radiated RF electromagnetic fields (IEC 61000-4-3), test level:

  • 10 V/m, 80 MHz–2.7 GHz, 80 % AM at 1 kHz

Proximity fields from RF wireless communications equipment (IEC 60601-1-2 Table 9), test level:

    Test Frequency
    (MHz)

    Band
    (MHz)

    Service

    Modulation

    Immunity test level
    (V/m)

    385

    380 to 390

    TETRA 400

    Pulse modulation
    18 Hz

    27

    450

    430 to 470

    GMRS 460, FRS 460

    FM
    ± 5kHz deviation
    1 kHz sine

    28

    710

    704 to 787

    LTE Band 13, 17

    Pulse modulation
    217 Hz

    9

    745

    780

    810

    800 to 960

    GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5

    Pulse modulation
    18 Hz

    28

    870

    930

    1720

    1700 to 1990

    GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS

    Pulse modulation
    217 Hz

    28

    1845

    1970

    2450

    2400 to 2570

    Bluetooth®, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7

    Pulse modulation
    217 Hz

    28

    5240

    5100 to 5800

    WLAN 802.11 a/n

    Pulse modulation
    217 Hz

    9

    5500

    5785

    Rated power frequency magnetic fields (IEC 61000-4-8), test level:

    • 30 A/m, 50 Hz
    • 30 A/m, 60 Hz

    Proximity magnetic fields (IEC 61000-4-39), test level:

    • 8 A/m, 30 kHz, CW modulation
    • 65 A/m, 134.2 kHz, pulse modulated, duty cycle 50 %, 2.1 kHz repetition rate
    • 7.5 A/m, 13.56 MHz, pulse modulated, duty cycle 50 %, 50 kHz repetition rate

    Protection Against Electrical Shock

    Electronic device of type BF according to the standard IEC 60601-1. Protection against electrical shock.

    Protection Against Ingress of Fluids

    IP28: The sensor is protected against the effects of temporary immersion in water at a depth of 1 meter for up to 60 minutes.

    Method of Sterilization

    Radiation

    Battery

    This product includes a battery containing a Substance of Very High Concern (SVHC), 1,2-dimethoxyethane (CAS 110-71-4), in a concentration above 0.1 % by weight, as identified under REACH and added to the Candidate List. There is no direct exposure to the substance, and therefore no risk when the sensor is operated according to the instructions for use.

    Performance Data

    Consult your healthcare professional to discuss the use of the following data.

    The performance of the Accu-Chek SmartGuide sensor was evaluated in a controlled clinical trial (data on file). The study was conducted in 3 clinical centers and included 48 people with Type 1 or insulin-dependent Type 2 diabetes (18 years and older). Each study participant was wearing 3 sensors over 14 days on the back of the upper arms. During the study, 3 sampling days with glucose manipulations were conducted, where capillary glucose measurements were taken as comparison values. In the study, 3 sensor batches were investigated.

    Figure 1: Regression analysis of sensor values in comparison to capillary measurements

    Figure:
    a = CGM Value [mg/dL]; b = Comparator Value [mg/dL]

    Table 1: Regression analysis

    Slope

    1.02

    Axis intercept

    -4.2 mg/dL (-0.2 mmol/L)

    Correlation (Pearson’s r)

    0.96

    N

    15993

    Range

    40–400 mg/dL (2.2–22.2 mmol/L)

    Overall MARD

    9.2 %

    Table 2: Sensor performance compared to capillary measurements at different glucose ranges

    Glucose

    Overall MAD/MARD*

    < 54 mg/dL (3.0 mmol/L)

    7.5 mg/dL (0.42 mmol/L)*

    54–69 mg/dL (3.0–3.8 mmol/L)

    7.0 mg/dL (0.39 mmol/L)*

    70–180 mg/dL (3.9–10.0 mmol/L)

    9.8 %

    > 180–250 mg/dL (10.0–13.9 mmol/L)

    8.0 %

    > 250–350 mg/dL (13.9–19.4 mmol/L)

    7.3 %

    > 350 mg/dL (19.4 mmol/L)

    4.9 %

    * For glucose < 70 mg/dL (3.9 mmol/L), the differences in mg/dL (mmol/L) are presented instead of relative differences (%).

     
    NOTE

    MARD (Mean Absolute Relative Deviation) is the mean of the absolute relative deviations of the CGM values from the simultaneously measured blood glucose values. MARD is determined as follows:

    • The simultaneously measured blood glucose value is subtracted from the CGM value. The absolute amount of the difference is put into percentage relation to the blood glucose value. The percentages of all pairs of values are added together and the result divided by the number of pairs of values (n).

    MAD (Mean Absolute Deviation) is the mean of the absolute deviations of the CGM values from the simultaneously measured blood glucose values. MAD is determined as follows:

    • The simultaneously measured blood glucose value is subtracted from the CGM value and the absolute amount of the difference is taken. The amounts of all pairs of values are added together and the result divided by the number of pairs of values (n).

    Table 3: Sensor performance compared to capillary measurements over sensor wear time

    Beginning

    Middle

    End

    Overall MARD

    8.3 %

    9.0 %

    10.8 %

    Table 4: Sensor performance according to agreement rates

    Total number of pairs

    Within ±15 mg/dL (±0.8 mmol/L) and ±15 % of the capillary measurements

    Within ±20 mg/dL (±1.1 mmol/L) and ±20 % of the capillary measurements

    Within ±30 mg/dL (±1.7 mmol/L) and ±30 % of the capillary measurements

    Within ±40 mg/dL (±2.2 mmol/L) and ±40 % of the capillary measurements

    Sensor performance overall

    15993

    13345

    (83.4 %)

    14471

    (90.5 %)

    15510

    (97.0 %)

    15803

    (98.8 %)

    Sensor performance < 70 mg/dL (3.9 mmol/L)

    1121

    998

    (89.0 %)

    1057

    (94.3 %)

    1112

    (99.2 %)

    1118

    (99.7 %)

    Sensor performance 70–180 mg/dL (3.9– 10.0 mmol/L)

    9793

    7923

    (80.9 %)

    8718

    (89.0 %)

    9444

    (96.4 %)

    9660

    (98.6 %)

    Sensor performance > 180 mg/dL (10.0 mmol/L)

    5079

    4424

    (87.1 %)

    4696

    (92.5 %)

    4954

    (97.5 %)

    5025

    (98.9 %)

    Note that all performance data shown represents data from sensors that had been calibrated by the user. In the study described, sensors that had not been calibrated by the user showed an overall MARD of 10.2 %.

    Adverse Events

    No serious adverse events, or device-related serious adverse events, occurred during the study. There were a total of 35 adverse events which occurred during the study. Of these, 15 were related, or possibly related, to the device. All of these 15 adverse events were related to reactions at the application site, such as short bleeding, pain, hematoma, erythema, mild inflammation, or pruritus.

    Declaration of Conformity

    Roche hereby declares that the radio equipment type Accu-Chek SmartGuide sensor is in compliance with Directive 2014/53/EU.

    The full text of the EU declaration of conformity is available at the following internet address:

    https://declarations.accu-chek.com