Product Highlight
Condition targeted:
Diabetes, Hypertension
How it works:
Dario includes an app, devices, and coaching to support people living with one or more behavioral and/or physical health conditions.
Impact:
Clinical
2.3 point reduction in HbA1c with a baseline >9 pts (ADA 2023)
1.7 point reduction in HbA1c with a baseline >8 pts (ADA 2023)
Economic
$5,077 estimated savings in paid claims over one year (ADA 2023)
23.5% reduction in in-patient hospitalization (ISPOR 2023)
Product Overview
Medical condition:
Diabetes, type 1 and type 2
Hypertension
Target patient population:
Dario provides a fully configurable, highly personalized digital therapeutic plus coaching solution for people living with one or more behavioral and/or physical health conditions. Dario combines easy-to-use, connected wireless devices, best-in-class web and mobile applications and digital plus human coaching to provide an adaptive, highly personalized experience for members.
What to expect:
Reduces A1c levels, reduces hyperglycemic and hypoglycemic events, and improves in-range readings for users with diabetes and hypertension. Long-term behavior change to support weight management, pain management, and behavioral health concerns.
Note: for more information, please visit https://www.dariohealth.com
Clinical Overview
Indications for use:
The Dario cardiometabolic solution includes the Dario mobile application, digital and human coaching with customized messaging, and connected devices (Dario Smart Blood Glucose Meter, Dario Blood Pressure Monitoring System, and Dario Digital Scale—appropriate devices are provided for applicable conditions).
Outcomes:
Dario measures outcomes through reductions in eHbA1c, blood pressure, weight, anxiety, depression, and pain – depending on which conditions are implemented. We also set performance targets with clients using metrics related to implementation, enrollment and engagement, member satisfaction, and behavior change. With data from 40+ clinical studies, Dario shows lasting results over two years with improvement across a variety of conditions that exceed market standards.
- 1.4% reduction in A1C and 60% reduction in hypo/hyperglycemic events
- 48% reduction in depression symptoms, 59% reduction in anxiety symptoms
- 54% reduction in severe pain
- 8.4 mmHg reduction in systolic blood pressure for 70% of members
Dario and Sanofi’s ground-breaking collaboration to set new standards in digital health research by analyzing real-world digital health data using the evidence generation standards of a pharmaceutical study. To read more about this research and outcomes from other studies that demonstrate the impact of Dario on utilization, clinical and financial outcomes. visit:
https://www.dariohealth.com/clinical-research/
https://letstalk.dariohealth.com/clinical-evidence
Directions:
The enrollment process guides people to set-up the wireless devices (such as a blood glucose meter, blood pressure cuff, smart scale, and/or MSK sensor), download the app, and connect with a coach.
Risks & warnings:
Dario’s solutions are only suitable for people over 18 years of age who use a smartphone and are comfortable using mobile applications (apps). The Dario system should be used in combination with a health care plan directed by a physician. This system should not be used for the following purposes: the diagnosis of or screening for any chronic conditions; testing of arterial or venous blood or from sites other than the fingertip; testing patients who are critically ill; any use of devices other than indicated by user guides.
Place in therapy:
Complementary to current therapy as directed by a physician.
Product Access
Product description:
The portfolio of solutions includes the Cardiometabolic Suite (support for pre-diabetes/weight management, diabetes, and hypertension), MSK program (digital musculoskeletal wellness and posture correction), and behavioral health solution.
The Dario solution combines software applications with automatically connecting devices and human coaching to provide integrated, personalized support for multiple conditions.
Members of the diabetes program receive Dario’s FDA approved, proprietary pocket-sized all-in-one blood glucose meter that connects directly to IOS (Apple) and Android smartphones via the smartphone charger connection as an integrated piece of the measurement experience with real-time data transmission of readings. The housing contains everything the member needs for testing- the dongle (which is the glucometer itself), a cartridge of test strips, lancet and firing mechanism (with unlimited replacement supplies). The small size fits easily into a pocket or purse and plugs directly into the member’s smartphone, integrating with the Dario app.
Members of the weight management program are sent Dario’s cellular-enabled digital weight scale that automatically connects with and uploads measurements to the Dario app.
Hypertension management members receive Dario’s cellular blood pressure monitor that transfers measurements into the Dario app.
MSK members receive a kit including our single biofeedback sensor and adjustable body bands in a range of sizes to be worn during exercises with the sensor attached, and to help correct posture. The Dario Move app guides members through a personalized training, education, and behavior change journey they can participate in anywhere, anytime at their convenience.
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:
To enable this communication, members can send reports directly from their Dario app to their providers or print to share during their scheduled provider visits. Coaches can also help members prepare for appointments, discussing questions the member might ask to help improve their results.
Coverage options:
The Dario solutions are available direct to consumer (D2C) and via business to business partnerships (B2B).
Product availability:
The Dario System is available in:
- USA: FDA-cleared Class II device
- Europe: CE mark received by European Notified Body
- Canada: Health Canada-cleared
- Australia: TGA-cleared
- Israel: approved by the Israeli Ministry of Health
DarioHealth Makes the Right Thing to Do the Easy Thing to Do.
Dario’s portfolio of solutions includes our Cardiometabolic Suite (support for pre-diabetes, diabetes, and hypertension), our MSK program (digital musculoskeletal wellness and posture correction), and our behavioral health solution, which triages individuals to the most appropriate care for them anywhere from self-guided programs to plan-sponsored therapy.
Clinical Trials
- Study Title: Decrease in Estimated A1C for people in High-risk over a full year of users monitoring with a digital Diabetes management system
Study Design: Retrospective study
Outcomes: 1.4% improvement in estimated eHbA1c - Study Title: Decrease in hypoglycemia events over two years in patients monitoring with digital diabetes management system
Features: Retrospective study
Study Design: Reduction of 40% in average high readings (>180 mg/dL) - Study Title: The Effect of Digital Intervention on Glycemic Control in Users with Diabetes
Study Design: Retrospective study
Outcomes: Increase of 38% of % In range measurements per total measurements versus baseline
This research is the first of several studies to be released based on this data analysis to demonstrate the impact of Dario on clinical, resource utilization and financial outcomes. To read more about this research, visit: https://www.dariohealth.com/clinical-research/