DTx Product Profile

Dario® Blood Glucose Monitoring System

Product Highlight

Condition targeted:

Type 1 and 2 diabetes

How it works:

  • The Dario Smart Meter and accompanying app helps people with type 1 and type 2 diabetes to perform self-testing to monitor the effectiveness of diabetes control.
  • Interaction with live coaches, and real-time data analytics provides hyper-personalized support for better health.


People with high-risk type 2 diabetes improved their A1c by 1.4% over 12 months.

Product Overview

Medical condition:

Diabetes, type 1 and type 2

Target patient population:

People with type 1 and type 2 diabetes who want the freedom to test their blood sugar when and where is most convenient and need support to track and managing their diabetes.

What to expect:

Reduces A1c levels, reduces hyperglycemic and hypoglycemic events, and improves in-range readings for users with diabetes.


Note: for more information, please visit https://mydario.com/.

Clinical Overview

Indications for use:

The Dario Smart Meter and accompanying app is approved for people with type 1 and type 2 diabetes to perform self-testing at home to monitor the effectiveness of diabetes control.


Highlights of DarioHealth’s 20 published clinical studies demonstrate reduction of 50% in hypoglycemia within 24 months and reduction of 14% in glucose variability sustainable for two years.


Dario makes it easy to perform regular blood glucose testing when and where people want. Users simply connect the Smart Meter to the smartphone charging port or audio jack and insert a new test strip into the meter. Users utilize the lancet in the Dario compact and place a drop of blood on the test strip. Dario will then display and automatically save the measurement. As Dario collects more data on the user’s health and lifestyle habits, Dario tailors insights and support, including personal coaching, to support unique wants and needs to improve health and outcomes.

Risks & warnings:

Dario’s Smart Meter is only suitable for people who use a smartphone and are comfortable using mobile applications (apps). The Dario system should not be used for the following purposes: the diagnosis of, or screening for, diabetes; testing glucose levels in children 4 weeks or younger; testing glucose levels of arterial or venous blood; testing glucose form sites other than the fingertip; testing patients who are critically ill.

Place in therapy:
Complementary to current therapy.

Product Access

Product description:

The Dario® Blood Glucose Monitoring System is a cloud-based diabetes management system that combines software applications with a stylish all-in-one device featuring a lancing device, test strip cartridge, and compact meter.

Prescription status:

A prescription is not required.

Patient access:

After purchasing the Dario Smart Meter online, users then download the Dario app from the Apple or Google App Store and receive instructions on how to complete onboarding.

Use of this product requires access to a mobile phone

Provider access:

Healthcare professionals have access to DarioEngage, the intelligent SaaS-based care management platform, giving providers access to real-time, highly accurate data and in-app messaging to facilitate timely, relevant interventions.

DarioEngage is open-by-design, enabling integration with EHRs and other care management platforms for seamless data access where it matters.

Coverage options:

The Dario® Blood Glucose Monitoring System is often covered by health plans and employer health plans as a benefit.

Product availability:

The Dario System is available in:

DarioHealth Makes the Right Thing to Do the Easy Thing to Do.

Dario’s innovative Smart Meter gives people with diabetes the ability to take control of their health. Our award-winning app empowers people with easy-to-use tools, real-time feedback and support from personal coaches to make positive changes that last.

Clinical Trials

The provided set of evidence represents a sample of conducted studies. For a comprehensive collection contact manufacturers directly.

Note: for more research, please visit https://www.dariohealth.com/clinical-research/.

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