Continuous Glucose Monitoring system

The GlucoMen Day® CGM is a real-time subcutaneous Continuous Glucose Monitoring System. Thanks to the unique GlucoMen Day® CGM Sensor technology the tiny Sensor wire is inserted under the skin without any guide needle, with reduced risk of insertion pain and bleeding.

The electrochemical enzymatic Sensor measures the glucose level in the interstitial fluid for 14 days, and the data are stored in the Transmitter and sent via Bluetooth to the dedicated App, which displays a new glucose value every minute.

Continuous Glucose Monitoring system

The GlucoMen Day® CGM is a real-time subcutaneous Continuous Glucose Monitoring System. Thanks to the unique GlucoMen Day® CGM Sensor technology the tiny Sensor wire is inserted under the skin without any guide needle, with reduced risk of insertion pain and bleeding.

The electrochemical enzymatic Sensor measures the glucose level in the interstitial fluid for 14 days, and the data are stored in the Transmitter and sent via Bluetooth to the dedicated App, which displays a new glucose value every minute.

TUTORIALS & GUIDES

FEATURES

TECHNICAL SPECIFICATIONS

THE GlucoMen® Day APP

CLINICAL DATA

TUTORIALS & GUIDES

FEATURES

TECHNICAL SPECIFICATIONS

THE GlucoMen® Day APP

CLINICAL DATA

Features

14 Day
Sensor Life

Sensor wear duration of 14 days.

Needle-free
Sensor Insertion

The Sensor wire can be inserted under the skin without any guide needle.

1 new data
every minute

1 new Glucose data displayed every minute.

Customizable
Alarms

Real-time alarms for high/low Glucose levels, rapidly changing Glucose, and predictive alarms.

Cloud Data
Sharing

Real- time cloud data sharing.

Eco
Friendly

All of the devices of the system are reusable, drastically reducing the waste of materials.

System Components

The GlucoMen® Day App

The GlucoMen Day® CGM dedicated App (for both Android and iOS smartphones) displays the latest glucose value (a new value every minute), trend arrow and glucose graph. The App allows the user to set and customise alarms for high and low glucose, rapid glucose change, and predictive alarms.

Data can be shared in real-time on a certified cloud, and accessed remotely by an authorised HCP or carer. Data analysis includes Time In Range, Average, SD, CV% and AGP, and can be performed directly by the App or by the GlucoLog web software.

Technical Specifications

Sensor + Transmitter Size: 3.5 x 2.5 x 0.9 cm

Sensor Duration: 14 days

Sensor Warm Up Time: 55 min 

Measurement Frequency: 1 min

Waterproofness: IP27

Sensor Storage Temperature: 5-35 °C

Calibration: 1/day (2 for day 1 only). For the calibration a dedicated glucose meter (GlucoMen Day METER) is provided for free with the Devices Kit, and 25 strips are provided for free with every CGM Sensor.

Intended Populations: Adults, Children (6+), pregnant women, persons on dialysis, and persons who are critically ill. Measuring Principle: Electrochemical measurement by wire-type GOD-based biosensor Measuring Site: Subcutis (interstitial fluid)

Insertion Area: Abdomen

Insertion Mechanism: Automatic

Insertion Type: Needle-free (sensor is inserted without any guide-needle)

Inserter Use Life: Reusable (up to 5 years)

Use Life: Reusable (up to 5 years)

Battery Type: Rechargeable

Recharge Time: up to 4 hours

Memory: 15 days of data

Transmission Distance: 3m

Transmission Type: Bluetooth Low Energy

Data Sharing: Cloud, email

Alarms: High/low glucose, rapid glucose change, predictive alarms

App Compatibility: Android and iOS (full list of compatible phones)

Data Analysis Software: GlucoLog, Diasend

Available Data Analysis (from App and Software): AGP, Time in Range, Average, SD, CV%

Clinical Data

Sensor Insertion Pain Assessment

Pain perception distribution over a pain scale of 0-20, comparing the GlucoMen Day® CGM Sensor insertion vs a finger prick (1).

The GlucoMen® Day CGM Sensor insertion pain has been reported to be on average 1.3 over a pain scale of 0-20. As a reference, finger pricking had an average score of 4.9 (1) GlucoMen Day CGM Technical File, CEVAL Study.

Skin Irritation Assessment

Results of skin irritation assessment after Sensor removal (1)

During the clinical trials no adverse events (Draize score ≥4) occurred both for erythema and oedema at the insertion site or under the adhesive. (1) GlucoMen Day® CGM Technical File, CEVAL Study.