Medical Disclaimer

Regulatory status

This software has not been cleared, approved, or certified by any regulatory authority worldwide, including but not limited to:

• The U.S. Food and Drug Administration (FDA)
• EU Notified Bodies (no CE marking under MDR 2017/745)
• Health Canada
• Australia’s Therapeutic Goods Administration (TGA)
• Any equivalent national regulatory authority

Not a medical device

This software is NOT a medical device. It is experimental open-source software provided for educational and informational purposes only. No individual, organization, or entity associated with this project is the “manufacturer” of a medical device under any regulatory framework.

GlycemicGPT does not control any medical devices. It reads data from insulin pumps and continuous glucose monitors (CGMs), displays that data, and provides AI-generated text suggestions. These suggestions are not medical advice and must not be treated as such.

Health data and AI providers

The self-hosted GlycemicGPT platform stores your data on infrastructure you control. However, whether health data leaves that infrastructure depends on which AI provider you configure:

• Cloud-hosted AI providers receive your glucose, insulin, pump, and therapy data context for inference. That data is then subject to the provider’s data-handling policy and the policies of any upstream providers it routes to.
• Local AI providers (models running on infrastructure you control, such as Ollama, vLLM, or llama.cpp) keep that data on your own network.

It is your responsibility to verify where your configured AI endpoint routes traffic and to review its data-handling policy before configuring it. See our Privacy Policy for how the platform itself handles data.

AI limitations

AI-generated suggestions are produced by large language models that are known to:

• Hallucinate — generate plausible-sounding but incorrect information;
• Misinterpret data — draw incorrect conclusions from glucose readings;
• Provide outdated information — not reflect the latest medical guidelines;
• Lack context — not understand your complete medical history, comorbidities, or current medications.

All AI-generated content is labeled as suggestions, not medical advice. Never act on AI suggestions without consulting your healthcare team.

Critical warnings

1. Do not replace professional medical care. Always consult your endocrinologist, diabetes educator, or healthcare provider before making any changes to your diabetes management.
2. Verify all suggestions. Any insulin dosing, carb ratio, or correction factor suggestion must be verified with your healthcare team before use.
3. Use extreme caution. Incorrect diabetes management can result in severe hypoglycemia, diabetic ketoacidosis (DKA), or other life-threatening conditions.
4. If you experience a diabetes emergency, contact your healthcare provider or emergency services immediately. Do not rely on this software for emergency medical guidance.

Third-party forks and device control

GlycemicGPT is a monitoring and analysis platform across all builds it ships; the plugin SDK is read-only by design and has no insulin-delivery primitives. Forks that modify the SDK to add device control or insulin delivery operate outside the GlycemicGPT project. The maintainers do not review, recommend, or accept liability for them.

Anyone who builds, installs, or runs such a fork becomes the manufacturer of their personal medical device and accepts full responsibility for that decision — the same posture used by DIY diabetes projects such as Loop and AndroidAPS.

Untested device compatibility

This software may declare protocol compatibility with devices that have not been tested against physical hardware. Protocol compatibility does not guarantee correct operation. Data from untested devices may be inaccurate, delayed, or missing, and connection behavior may differ. Safety-critical values (insulin on board, glucose readings, basal rates) must always be verified against the device manufacturer’s official companion app. Users who use this software with untested hardware accept all associated risk.

Limitation of liability

THE AUTHORS, CONTRIBUTORS, AND MAINTAINERS OF THIS SOFTWARE PROVIDE IT “AS IS” WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NONINFRINGEMENT. IN NO EVENT SHALL THEY BE LIABLE FOR ANY CLAIM, DAMAGES, OR OTHER LIABILITY — INCLUDING ANY DAMAGES, INJURIES, OR ADVERSE HEALTH OUTCOMES — ARISING FROM OR IN CONNECTION WITH THE SOFTWARE OR ITS USE.

By using GlycemicGPT, you acknowledge that:

• You are using this software entirely at your own risk;
• You will not rely solely on AI-generated suggestions for medical decisions;
• You understand that AI can and will make errors;
• You will maintain regular care with qualified healthcare professionals;
• You accept full responsibility for any decisions made based on this software’s output;
• No individual or entity associated with this project is liable for medical outcomes.

This software is licensed under the GPL-3.0; see Sections 15–17 of the Terms of Use and the LICENSE for the full warranty disclaimer. Limitation-of-liability clauses for personal injury may be unenforceable in some jurisdictions. This disclaimer does not constitute legal advice.