Medical Disclaimer
Open-D is an AI companion, not a medical device. Please read this carefully.
TL;DR — The Short Version
- !Open-D is NOT a medical device. It is an AI companion that helps you understand your diabetes data.
- !Do not use Open-D to make insulin dosing decisions without consulting your healthcare provider.
- !Always consult your doctor for clinical decisions, medication changes, and treatment plans.
- !In emergencies, call emergency services. Do not rely on an app.
1. Not a Medical Device
Open-D is an AI Diabetes Agent — a software companion designed to help people with Type 1 Diabetes understand their glucose patterns, log data, and receive personalized coaching insights. It is not a medical device, diagnostic tool, or replacement for professional medical care.
Open-D has not been evaluated by the FDA, EMA, or any other regulatory body for medical devices. It does not diagnose, treat, cure, or prevent any disease.
2. No Medical Advice
All information, suggestions, and insights provided by Open-D and its AI agents are for informational and educational purposes only. They do not constitute medical advice, diagnosis, or treatment recommendations.
The AI agents may suggest patterns, timing adjustments, or lifestyle changes based on your data. These are suggestions, not prescriptions. Always verify any recommendation with your healthcare provider before acting on it.
3. Insulin Dosing & Treatment Decisions
Open-D includes a SmartDose calculator that provides estimated insulin dose suggestions based on your input. These calculations are:
- • Based on the information you provide
- • Influenced by your historical patterns
- • Not verified by a medical professional
- • Subject to error if input data is incorrect or incomplete
Never use Open-D's dose suggestions as your sole basis for insulin administration. Always confirm doses with your prescribed treatment plan and your healthcare provider's guidance.
4. Emergency Situations
If you experience severe hypoglycemia, diabetic ketoacidosis (DKA), or any other medical emergency:
- • Call emergency services immediately (911 in the US, 112 in the EU)
- • Contact your emergency contact or family member
- • Use glucagon if prescribed and trained
- • Do not rely on Open-D for emergency medical guidance
Open-D's Night Watch feature sends alerts and can notify your emergency contact, but it is not a substitute for emergency medical care.
5. CGM & Device Accuracy
Open-D syncs with Freestyle Libre 3 and (soon) Dexcom CGMs. The accuracy of glucose readings depends entirely on your CGM device. Open-D does not verify or correct CGM readings.
Always follow your CGM manufacturer's instructions for calibration, sensor replacement, and accuracy limitations. If a reading seems wrong, confirm with a fingerstick blood glucose test.
6. Your Healthcare Team Comes First
Open-D is designed to complement your relationship with your healthcare provider, not replace it. Share your Open-D data, reports, and insights with your endocrinologist, diabetes educator, or primary care physician as part of your ongoing care.
Regular medical check-ups, A1C tests, and professional diabetes management remain essential.
7. Liability Limitation
By using Open-D, you acknowledge and agree that:
- • You use the app at your own risk
- • Open-D and its creators are not liable for any health outcomes resulting from use of the app
- • You are responsible for verifying all health-related decisions with qualified medical professionals
- • The app's suggestions are estimates, not medical prescriptions
8. Changes to This Disclaimer
We may update this medical disclaimer as the app evolves. We will notify users of significant changes through the app and update the date below.
Last updated: April 25, 2026