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Insulia Digital Therapeutic

Insulia from Voluntis

Insulia, available via mobile app or web portal, is an FDA cleared, prescription-only medical device that recommends basal insulin doses for adults with type 2 diabetes based on the treatment plan created by their healthcare provider.

For complete information, visit Insulia

Comprehensive Diabetes Management:
No
Journal: Glucose & Meal Tracking:
No
Nutrition analysis:
No
Fitness tracking:
No
Device Specific:
No
Medical Profile Storage:
No
Insulin dosing:
Yes
Education :
No
CGM Companion App:
No
Coaching:
No
For ADCESs & Healthcare:
Providers
Remote Patient Monitoring:
Yes
Data Management Platforms:
No
HIPAA Compliant Virtual Visit Platforms:
Yes
Insulin dosing in Hospital:
No

FDA & Regulatory:
Insulia® is an FDA cleared, prescription-only app that uses clinical algorithms to recommend daily basal insulin doses to people with type 2 diabetes.
Outcomes:
The Telediab 2 RCT in France using Diabeo-Basal*, a predecessor to Insulia, in insulin naïve T2D patients (A1C 8.9±1.1%) showed a statistically significant A1C difference in the control vs. Diabeo-Basal groups at four months (7.96±0.88% vs 7.47±0.9%, p=0.0017); two fold more patients in the Diabeo-Basal group achieved A1C <7% vs. control (29.8% vs 12.5%). This study showed that interventions using automated insulin titration software improved glucose control as compared with standard care.
Data Sharing:
The healthcare team is responsible for the initial set up of the app for their patient through a web portal for healthcare professionals (HCPs). The patient data is automatically shared with the health care team who can remotely monitor the patient’s progress toward their goal.
Platforms & Modalitiy:
The Insulia HCP web portal can be used on a PC or a tablet. The Insulia patient app can be used on iOS and Android smartphones and tablets. A web version is also available for patients who prefer to use Insulia on their PC.
Security & Privacy:
Insulia is hosted in the cloud in a fully HIPAA compliant environment. Patient data is protected according to the privacy policy available at insulia.com/privacy. To ensure the security of Insulia, Voluntis performs code reviews, manual tests, and automated penetration testing. Cybersecurity activities and audits are conducted on a regular basis and all critical and high risks are corrected (in accordance with ICO 14971 and FDA’s cybersecurity guidance.)
Cost & Payment:
Insulia is free for patients to download. However, patients cannot use the application until they receive an activation code which is generated by their clinician from the Insulia HCP portal. To sign up for an HCP portal, or to get more information about Insulia, go to insulia.com/pro
More Details:

For people with type 2 diabetes, calculating a daily dose of basal insulin can be challenging. Insulia® makes it easier by giving the patient a dose recommendation at the time they need it.

Insulia® is an FDA cleared, prescription-only app that uses clinical algorithms to recommend daily basal insulin doses to people with type 2 diabetes. Whether patients are just starting on basal insulin or having difficulty getting to their glucose goal, an HCP can prescribe Insulia to get them on the right track.

The HCP can create a treatment plan tailored to each person’s needs and an activation code is generated that allows the patient to log into the Insulia app. The patient adds daily fasting blood glucose readings, and Insulia recommends a basal insulin dose every day. In the HCP web portal, the HCP follows a patient’s progress in real-time and helps them when needed.

Important Information:

Insulia® is a prescription-only software medical device intended for use by healthcare professionals and their type 2 adult diabetes patients treated with long-acting insulin analogs as an aid in the management of diabetes. Insulia® is only indicated for use with basal insulins supported by the device. Insulia® is not intended for use by pregnant women, non-adult patients or patients that are treated with a basal-plus or a basal-bolus regimen (i.e. including multiple mealtime insulin injections per day or insulin pump therapy).

*Diabeo-Basal is not approved nor cleared for use in the US.


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DISCLAIMERS:

This site and its services do not constitute the practice of medical advice, diagnosis or treatment. Always talk to your diabetes care and education specialist or health care provider for diagnosis and treatment, including your specific medical needs. If you have or suspect that you have a medical problem or condition, please contact a qualified health care professional immediately. To find a diabetes care and education specialist near you, visit the ADCES finder tool.

ADCES and danatech curate product specifics and periodically review them for accuracy and relevance. As a result, the information may or may not be the most recent. We recommend visiting the manufacturer's website for the latest details if you have any questions.


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