Hedia

YOUR DIABETES ASSISTANT

Hedia Diabetes Assistant is a certified medical bolus calculator. We’ve designed it to help you safely manage your insulin requiring diabetes.

IN HEDIA DIABETES ASSISTANT YOU CAN

– Get insulin or carbohydrate recommendations based on your current glucose, recent insulin, carbohydrate intake, and physical activity.

– Use connected devices to transfer data into your logbook or bolus calculations.

– Get an overview of your glucose levels over time.

– Get an overview of your active insulin.

– Use the built-in food library or add your personal food items.

– Share your logged data with your healthcare professional.

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Hedia Diabetes Assistant is regulated as a medical device under Medical Device Regulation (EU) 2017/745

INTENDED USE

Hedia Diabetes Assistant is a multi-platform application (software as a medical device) with no body contact, intended to support the decision-making of rapid-acting bolus insulin dose for the management of insulin-dependent diabetes by providing the user with an insulin bolus dose

recommendation.

INDICATIONS FOR USE

Hedia Diabetes Assistant is intended to be used when the user would normally check glucose and inject insulin. The indications for using Hedia Diabetes Assistant are:

– Type 1 or 2 diabetes treated with rapid-acting insulin.

– The user has to have the cognitive and physical skills to use mobile applications.

The users’ insulin treatment is prescribed, monitored, and managed by their health care professional (HCP).

CONTRAINDICATIONS

For safety reasons, Hedia Diabetes Assistant should not be used by persons with the following conditions.

– Pregnancy

– Gestational diabetes

– Under the age of 18 years