GlucIQ logs glucose readings, imports them from services you connect, estimates the nutrition of a meal, and runs arithmetic on the clinical parameters you or your clinician entered. It holds no clearance, certification, or approval in any market.
What the app does
GlucIQ logs the glucose readings you type in, along with insulin events, meals, activity, and fasting sessions. Readings also arrive by import when you connect a service such as LibreLinkUp, Dexcom, Dexcom Follow, or Glooko; the numbers then come from that provider’s system, and their accuracy is that provider’s responsibility. History and trend views redraw your own readings and notes. A meal photo, a menu, a barcode, or a text search returns a nutrition estimate. The app shows the portion it assumed so you can correct it before saving.
The arithmetic features work only on parameters you or your clinician entered: a carbohydrate ratio, a correction factor, a glucose target, a maximum bolus. Every result carries the parameters used beside it, and the app asks you to confirm it with your clinician.
GlucIQ does not measure glucose, does not diagnose, does not prescribe, and does not adjust therapy. It does not control a pump or any other device.
How a regulator decides
Intended purpose governs. A regulator reads it from the labels, the instructions, and the promotional material, and from what the software actually does when a person runs it. FDA states the test directly in its clinical decision support guidance. In the European Union, Article 2(12) of the Medical Device Regulation defines intended purpose the same way. A disclaimer does not change it. If a feature computes a dose for that user, the analysis stays the same.
The five markets
| Market | The rule | The class |
|---|---|---|
| United States | A patient-facing dose calculator is a device. 21 CFR 862.1358 covers it under product codes QRX and QCC; 21 CFR 868.1890 covers a standalone calculator under code NDC. FDA’s clinical decision support guidance uses a bolus calculator as its example and calls it a device because it is patient-facing and time-critical. A CGM pattern fed into the calculation independently keeps it a device. | Class II, 510(k) required, not exempt |
| European Union | Annex VIII Rule 11 of the Medical Device Regulation. Software that provides information used to take therapeutic decisions is Class IIa, rising to Class IIb where a wrong decision can cause serious deterioration, and to Class III where it can cause death or irreversible harm. MDCG 2021-24 treats diary software as outside the MDR unless an analysis is performed on the data. | IIa minimum, IIb defensible, III at the top |
| Germany | The MDR applies through the German MPDG. A DiGA listing under §33a SGB V is an optional reimbursement route. Since March 2024 it also covers Class IIb, and it excludes only devices that control an active therapeutic product, device-specific products, and Class III. The HWG bars cure claims. | Same as the EU |
| United Arab Emirates | Federal Decree-Law 38/2024 Article 1 includes operating software and AI-based products in Medical Equipment. Article 5(1) requires EDE Marketing Authorization. Articles 44 to 46 require approval for medical advertising. Article 164(2)(c) carries one to five years and a fine of AED 100,000 to 500,000. | Class I to IV, approval required |
| India | S.O. 648(E) brings medical-purpose software into the device regime, and CDSCO’s guidance lists insulin-dose software as medical device software. A standalone patient calculator is most plausibly Class C. The label must carry the license and registration numbers. The Drugs and Magic Remedies Act bars advertising for a scheduled disease, and diabetes is item 9. | Class B to D, most plausibly C |
Our current status
GlucIQ holds no clearance, certification, or approval as a medical device in the United States, the European Union, Germany, the United Arab Emirates, or India, and nothing on this site or in a store listing implies one. No diagnostic or therapeutic claim is made. Where the app shows arithmetic, it shows a calculation on inputs you or your clinician supplied, prints the parameters it used beside the result, and asks you to confirm it with your clinician before you act. Whether the app should offer a feature that turns those inputs into a dose at all is an open product decision, and no page, screenshot, or store listing will describe GlucIQ as calculating a dose until that decision is settled.
What would change this page
A clearance in any market would be published here with its reference number. A decision to remove a feature would be stated here in the same version that carries the change.
What not to do with GlucIQ
Do not dose from an estimate. Do not treat any number GlucIQ shows as an instruction.
Do not make the app your only record in an emergency. Responders need a care plan they can read without your passcode. Keep your care team in the loop.
Call 998 or 999 in the United Arab Emirates, 112 in the European Union and the United Kingdom, or 911 in the United States.
Formulas and sources
The formulas and the published source behind each constant are on the Methodology page.