Medical Disclaimer

What this document answers

This document is about one thing: what the numbers in glumea mean, and what they do not.

Will glumea warn me if I am going low? Section 4.1. The short answer is no, read that section before you rely on anything.
What is that number on my summary card? Section 4.2 takes each figure in turn and says what it is and is not.
Can I trust readings imported from Apple Health or Health Connect? Section 4.3.
Can I show the PDF report to my doctor? Section 4.4, yes, as a logbook, not as a clinical report.
Is glumea an approved medical device? Section 6. No, and that section says exactly what that means.
In an emergency? Section 2. Call your local emergency number, not the App.

1. Scope and who we are

Paweł Milewski Software Development (the Operator, “we”, “us”, “our”) provides the glumea mobile app (the App) and the glumea.com website (the Website). This Medical Disclaimer applies to both. It forms part of our Terms of Service and also applies on its own to everyone who uses the App or visits the Website.

For how we handle your data, see the Privacy Policy. If you are in Washington State, see also our Consumer Health Data Privacy Policy; in Nevada, our Nevada Consumer Health Data Privacy Notice.

2. In a medical emergency, call 112 (EU), 999 (UK), 911 (US), or your local emergency number now

glumea is not for emergencies. If you think you are having a medical emergency, such as severe hypoglycemia (very low blood sugar) or diabetic ketoacidosis (DKA), call your local emergency number immediately: 112 in the EU, 999 in the UK, 911 in the US. Do not wait for the App, do not rely on anything shown in the App, and do not use the App to decide whether to call.

3. What glumea is

glumea is a self-management logging and awareness tool for people living with diabetes. Its purpose is to keep a record of what you put into it and show that record back to you. It lets you:

log blood glucose readings, food and carbohydrates, insulin doses, other medications, and body weight
review your own entries as history, charts, and simple statistics
set up reminders for yourself
export or share a copy of your own records

Almost everything the App shows you is your own entries, restated, combined with settings you or your healthcare team put in (for example your glucose target range and your insulin sensitivity factor) and with simplified arithmetic built into the App. Some of those settings start as general defaults until you change them.

glumea cannot see your blood sugar. It knows only what you have written down or imported. Everything else in this document follows from that.

There is one source of information that is not typed in by you: if you connect Apple Health or Health Connect, glumea reads records from them. That is described in its own section below.

glumea is not directed at children. The age requirements, including the age at which you may use the App and what applies to a paid subscription, are set out in the Terms of Service.

4. What glumea does with what you log

4.1 What glumea does, and does not do, about a dangerous reading

glumea will not warn you that you are going low. It has no sensor and no alarms. All it can do is remind you to check again after you have typed a reading in yourself, at fixed numbers that are not your target range, and for some profiles it switches those reminders off automatically, without asking. Open Settings → Notifications → Safety alerts and check the state of yours, the group switch and the three reminders inside it, because turning one on without the other delivers nothing. The rest of this section is the detail.

glumea does not monitor you. It is a manual logbook, not a continuous glucose monitor. It has no sensor, it does not measure anything, and it knows nothing about the time between your entries. It cannot detect a low or a high that it was never told about. If your blood sugar drops dangerously and you do not log a reading, nothing at all will happen in glumea.

glumea has no alarms. There is no siren, no escalation, and no alert that overrides your phone. Its notifications are ordinary local notifications scheduled by the App on your own device. On iOS, low-glucose recheck reminders are sent as time-sensitive notifications, which means iOS may show them during a Focus mode if you have allowed that for glumea. They are not iOS Critical Alerts, the category Apple reserves for medical alarms, which requires a special entitlement glumea does not have. Nothing in glumea can sound through silent mode, and nothing in glumea can work around a notification permission you have denied. On Android these reminders use a high-importance channel, and glumea does not ask Android to bypass Do Not Disturb. They do ignore one thing: glumea’s own Quiet hours setting, which does not suppress them. And nothing in glumea will notify a family member, a caregiver, a clinic, or emergency services.

What glumea does have is recheck reminders. In Settings they are called Safety alerts. After you log a glucose reading past a fixed threshold, the App can schedule a reminder on your phone to check again:

below 3.9 mmol/L (about 70 mg/dL), two reminders, 15 minutes and 30 minutes after the time of that reading
above 13.9 mmol/L (about 250 mg/dL), one reminder 90 minutes after the time of that reading, or 60 minutes instead if the reading is above 16.7 mmol/L (about 300 mg/dL)

The thresholds are strict: a reading of exactly 3.9 or exactly 13.9 mmol/L schedules nothing. The App can also remind you if a long-acting or premixed insulin dose you scheduled yourself has not been logged.

Pending recheck reminders are canceled when a later reading suggests you have recovered, a low recheck is canceled once you log a reading of 3.9 mmol/L or above, and a high recheck is canceled only once you log a reading of 10 mmol/L or below, not merely once you are back under 13.9.

These reminders have the following limits:

They are triggered by the act of logging. No entry, no reminder.
They are timed from the reading, not from when you typed it in. If you log a reading late, any reminder whose moment has already passed is simply not scheduled: log a low 40 minutes after you took it and you get no recheck reminder at all.
Readings imported from Apple Health or Health Connect do not trigger them. A low that arrives in glumea by import produces no reminder of any kind. A reading that reaches this phone by cloud sync because you logged it on another device does not trigger one either, with one exception: if you grant notification permission from inside the App within 90 minutes of the time of the reading, the App looks back over recent readings and may schedule a recheck for it then. Granting the permission in your phone’s own Settings does not trigger that look-back, and a reading you backdate is measured from when it was taken, not from when you typed it in.
The thresholds are fixed. They are general clinical anchors and they do not follow the personal target range you set in the App. You can be well outside your own target, and outside the range your healthcare team set for you, and get no reminder, because the App only reacts at the fixed numbers above.
A reminder is not a diagnosis. It means “a number you entered was past a fixed line, please check again”. It is not an assessment of your condition and the notification itself does not tell you what to do about it.
They can be switched off, and for some people they are off from the start. If the diabetes profile you set up is not type 1 and does not include insulin treatment, glumea turns the whole Safety alerts group off when you finish setting up your profile, without asking, the group switch itself, and all three reminders inside it: low, high, and missed long-acting or premixed insulin. Turning an individual reminder back on is not enough: the group switch has to be on as well, or nothing will arrive. You will get no recheck reminder of any kind until both are on. Whatever your profile, open Settings → Notifications → Safety alerts and check the actual state of yours.
Delivery is never guaranteed. They can fail, arrive late, or not appear, see the accuracy limits below.

Never rely on glumea to warn you. Use your meter, your CGM and its own alarms, and the plan your healthcare team gave you.

4.2 The numbers glumea shows you

The App displays figures worked out from your entries:

average glucose, and the spread of your readings (SD and CV)
Time in Range: the share of the readings you logged that fall in each zone. It counts readings, not time: this is not the CGM-derived Time in Range your clinic works with, which measures how much of the day you actually spent in each zone, and the two will not agree. The in-range band is the target range you set (3.9–10 mmol/L until you change it); the two outermost zones are split off at fixed numbers built into the App, below 3.0 and above 13.9 mmol/L
Estimated A1C (GMI): a fixed formula applied to your average glucose, shown whenever the period you are looking at spans at least 14 days
active insulin: an estimate of how much of the fast-acting insulin you logged is still working, shown as an approximate number of units, a phase word, the App uses four: “Effect rising”, “Effect peaking”, “Effect fading”, “Effect holding steady”, and an activity bar; on the summary card it can be accompanied by wording about hypo risk, and in the detail view by a rough range of how much that remaining insulin could lower your blood sugar
a suggested time for your next reading, with a short reason for the timing
a status label for your latest reading: Good, Fair, or Critical

All of it:

is for awareness only
is arithmetic applied to the data you entered, using simplified models and the settings in the App
is not clinically validated: the models are product decisions, not validated clinical algorithms
can be wrong, incomplete, or out of date whenever an entry is missing, mistyped, or logged late, and none of it can account for food, activity, illness, stress, or how your body actually absorbs insulin

Never use any of these figures to decide a dose or to make any other therapy decision.

Four of these carry further limits, set out below.

Active insulin. Only fast-acting (bolus) insulin is counted. Long-acting (basal) and premixed insulin are not included in the figure at all, and nothing tells you so on the screen. The estimate assumes each dose wears off evenly over the duration set for that insulin, a straight line, not how insulin actually behaves in a body.

The App also performs one forward-looking calculation with it. If you have entered an insulin sensitivity factor and you have a glucose reading from the last 30 minutes, the App subtracts (remaining insulin × your sensitivity factor) from that reading. If the result falls below the fixed low line of 3.9 mmol/L, the summary card shows “Low sugar possible”, and that wording takes precedence: it replaces the quieter line entirely. The quieter line, “Hypo risk - elevated”, appears only where the result is above 3.9 but still below the bottom of the target range you set, so if your own target floor sits at or below 3.9, you will never see it, because the fixed line covers the whole span. That is a single subtraction performed on two numbers you supplied. It is an estimate of where a single reading could go if the insulin acted as the App assumes and nothing else changed. It is arithmetic on what you logged, not a measurement of you, and it is not clinically validated. It is not a dose calculation, and it is wrong whenever either number is wrong. The detail view adds a deliberately wide band around the estimated drop: how much the remaining insulin might lower your blood sugar, not around the predicted reading. It is not an exact figure.

The App can also be silent: showing nothing about risk at all, at a moment when you are genuinely at risk. That happens whenever it has no usable insulin sensitivity factor for you: you have not entered one, or a stored value falls outside the range the App accepts. The App will not let you save a sensitivity factor outside roughly 0.8–8.5 mmol/L per unit (about 14–153 mg/dL per unit), it marks the field as an error instead of saving it. The calculation itself is less strict than the form: a value that reached your account another way, from an older record or from another device, is still used so long as it is above zero and not absurdly large. In practice the usual reason for silence is simply that you have never entered one. The hypo wording is also withheld for the first 20 minutes after a dose: in that window the card says only that it has been less than 20 minutes since the shot, even when the arithmetic already lands below the low line. Silence is not reassurance. Check your blood sugar.

Your next reading. The suggested time is chosen by a fixed set of rules from what you logged, your last reading, how fast it moved compared with the reading before it, recent doses and how they are timed, meals, tags you added, and from the time of day: overnight the App may suggest a second, separate check some hours later. Each is shown with a short reason for the timing. It is a timing suggestion. It is not clinically validated and it is not an assessment of your condition. Some of those reasons are written in everyday diabetes-care language and mention things like treating a low or waiting for a correction to work; that wording is generic text attached to a rule, not advice about your situation. Follow the plan your healthcare team gave you, not the App.

Estimated A1C (GMI). This is not a laboratory HbA1c and it is not a substitute for one. The published GMI formula was derived from continuous glucose monitoring, where the average it is applied to comes from readings taken every few minutes around the clock. glumea applies that same formula to the average of the readings you happened to log, so it moves with when and how often you test: a logbook of mostly fasting readings, or a week you tested more because you felt unwell, will produce a number that does not match a lab result. It does not require any particular number of readings, if the period you are viewing is at least 14 days long, a handful of readings will still produce a number. Do not treat it as a lab value, do not use it to judge whether your treatment is working, and do not use it in place of the blood test your clinician orders.

The status label. Good, Fair and Critical are display labels for where a single reading sits on a scale. On the card showing your latest reading the in-range wording is phrased differently, it tells you that you are in your target range, and adds near low when the reading is within 0.6 mmol/L of your floor; Good appears where a reading is shown as no longer current. Their inner edges come from the target range you set; their outer edges are fixed numbers built into the App (below 3.0 mmol/L and above 13.9 mmol/L). “Critical” is a label on a number you entered, not a clinical assessment of you, and it triggers nothing on its own beyond what is described in the recheck-reminders section above.

4.3 Data you bring in from Apple Health or Health Connect

If you connect Apple Health or Health Connect, glumea reads blood glucose, body weight, and carbohydrate records from them and saves them as ordinary entries in your diary. Those imported entries then feed the same charts, statistics, and exported reports as anything you typed in. glumea only reads; it never writes anything back into Apple Health or Health Connect.

What that means for safety:

glumea does not validate imported data. It does not check, correct, or judge the values it reads. It does not know how a value was produced, which device produced it, or whether that device was calibrated. Anything wrong in the source is wrong in glumea, and then wrong in every statistic and report built on it.
Importing is not live. Records are read when the App runs an import, when you open the App, when you tap Sync now, when you switch on a data type to import, when you first connect the platform, when you sign in, when a glumea+ subscription becomes active, after you import a .glumea archive, or when you turn Cloud sync on, not continuously and not in the background. Only the automatic import when you open the App is throttled, to once every 5 minutes; the others run straight away. The first import after you connect reaches back 30 days and no further, and where our servers already hold records from that platform it may reach back no further than the newest of them. glumea also stores the name the meal was given in the other app, which is free text written outside glumea. A reading that exists in Apple Health right now may not be in glumea yet.
Imported readings do not trigger recheck reminders, as set out above.
Connecting is your choice, and you can disconnect at any time in Settings. How this data is handled is described in the Privacy Policy.

You can export the readings and entries from the period you are viewing as a CSV file or as a formatted PDF report, and share either one, including with your doctor or diabetes team. The PDF report is a glumea+ feature; the CSV is not. The export covers your glucose readings, insulin doses, tablets, other injectables, and food entries for that period. The PDF also prints a statistics block over the same period, estimated A1C, Time in Range, the spread of your readings, daily figures, and counts of low and very low readings including those overnight, together with your target range. It is not everything in the App: body-weight entries, for example, are not in it.

An exported report is a summary of your own entries, produced automatically by the App. It is not a clinical report. No clinician wrote it, no clinician reviewed it, and nothing in it is validated. Everything in this disclaimer applies to it: it is only as complete and as correct as what you logged, the daily summaries in it leave out detail, and figures such as Estimated A1C (GMI) carry the limits described above.

Please treat it, and please ask your healthcare team to treat it, as your logbook. It is a conversation aid, not a diagnostic document, and it is not a substitute for laboratory results or for readings from a glucose meter or CGM that is legally marketed for this use where you live.

5. glumea+ changes nothing here

Some of what the App does is part of glumea+, our paid subscription: cloud backup and sync, the PDF glucose report, and the statistics for the 30-day and 90-day chart windows. Paying changes nothing in this Medical Disclaimer. Paid features carry exactly the same limits as free ones: still a record of what you entered, still not medical advice, still not a dosing tool, still not clinically validated. The PDF report you share with your care team is covered by section 4.4 however you obtained it, and a statistic does not become clinically validated by being shown over 90 days instead of 14. What is included in the subscription is described in the Terms of Service. Nothing shown on the subscription screen, in the app stores, or on glumea.com changes what these figures are or what they mean; where any of them describes a paid feature in terms this document contradicts, this document is the one that applies.

6. What glumea is not

glumea’s intended purpose. glumea is intended for people aged 16 and over who live with diabetes: to keep a personal record of glucose readings, food, insulin, other medications and body weight; to show that record back to them as history, charts and simple statistics; and to show figures calculated from it, an estimate of the fast-acting insulin still working, wording about the risk of low blood sugar and an approximate lowering range, a suggested time for the next reading, and a status label on the latest reading. Section 4.2 sets out what each of those figures is and is not. It is not intended to diagnose, treat, cure, mitigate or prevent any disease or condition, to monitor your blood sugar, or to calculate, recommend or adjust any dose. It carries no medical-device marking, certification or registration anywhere: no CE marking under the EU Medical Device Regulation (Regulation (EU) 2017/745), no UKCA marking and no registration with the UK Medicines and Healthcare products Regulatory Agency (MHRA) under the Medical Devices Regulations 2002, which apply in Great Britain, and in Northern Ireland, where the EU regulation applies instead, likewise no CE marking; and no clearance, approval or authorization from the US Food and Drug Administration (FDA). Those are statements about regulatory status, not a claim that the App has been assessed and found safe by anyone.

glumea does not give medical advice, and it never replaces your healthcare team or the devices you use to measure your blood sugar. In particular:

Not a diagnostic or treatment tool. The App is not intended to, and does not, diagnose, treat, cure, mitigate, or prevent diabetes or any other disease or condition.
Not medical advice. Nothing in the App or on the Website is medical advice, diagnosis, or treatment. All content is general information only.
Not a dosing tool. The App does not calculate, recommend, or adjust an insulin dose or any other medication dose, and it must never be used for that purpose. It stores the two dosing settings your healthcare team gave you, your insulin-to-carb ratio and your insulin sensitivity factor. Your insulin-to-carb ratio is stored, shown back to you in your Diabetes profile, and printed on the PDF report you export when that period contains an insulin dose; nothing in the App calculates a dose from it. Your insulin sensitivity factor is stored, shown back to you in your Diabetes profile, and used in one further calculation: the App multiplies it by the fast-acting insulin it estimates is still working, subtracts the result from a glucose reading you logged in the last 30 minutes, and uses that figure for the hypo-risk wording on the summary card and for the rough lowering range in the detail view. Section 4.2 sets out what that calculation is and is not. Nothing in the App calculates, recommends, or adjusts a dose from either setting.
Not a monitor and not an alarm system. The App does not watch your blood sugar and does not raise alarms. What it can do is remind you to re-check after you log a concerning reading yourself. Section 4.1 sets out what those reminders do and do not do.
No predicted glucose curve. The App does not project where your blood sugar is heading over time and shows no forecast curve. It performs two forward-looking calculations on numbers you supplied, described under Active insulin and Your next reading in section 4.2. Both are estimates calculated from what you logged; neither is a measurement, and neither is clinically validated.
Not connected to your therapy devices. The App does not connect to, control, program, or change the settings of an insulin pump, a pen, a meter, or a CGM, and it does not alter data those devices produce.
Not a reminder you can rely on. The App can show optional reminders as a convenience. Reminder delivery depends on your device and its operating system and is not guaranteed. Never rely on the App to remind you to take, or to time, insulin or any other medication.
Not a replacement for the devices that measure you. The App is not a substitute for a blood glucose meter, a continuous glucose monitor (CGM), or any other device that is legally marketed for measuring or monitoring your blood sugar where you live.

7. No doctor-patient relationship

Using the App or the Website does not create a doctor-patient relationship, or any other professional or clinical relationship, between you and Paweł Milewski Software Development.

8. Accuracy limits

The App works with data you enter yourself. Entry mistakes lead to misleading numbers, charts, statistics, and reports.
Derived figures are estimates produced by simplified models. They are not clinically validated.
Statistics such as Time in Range are calculated against the clinical settings in the App, for example your glucose target range. Some settings start as general defaults until you change them. Enter only the values your healthcare team gave you (for example your glucose target range, insulin-to-carb ratio, and insulin sensitivity factor); otherwise the App’s statistics may not reflect the targets your healthcare team set for you.
Reminders and safety alerts are scheduled on your own device. Their delivery depends on that device, its settings, and its operating system: notifications can fail, arrive late, or never be shown, for example when notification permission is not granted, the device is off or silenced, when a Focus or Do Not Disturb mode suppresses them, when battery saving delays background work, or when the operating system simply drops them. Never rely on a notification as your only prompt to take, skip, or time insulin, any other medication, a glucose check, or any other treatment step.
Data imported from Apple Health or Health Connect is not validated by glumea, as set out above.
The App can be unavailable, and data can be delayed, duplicated, or lost, for example on a failed sync, a device problem, or a lost or replaced phone. Do not treat glumea as your only record of your health data. Keep your own copy, and export one regularly if the record matters to you.

9. Trust your meter and your healthcare team, not this app

Make therapy decisions only together with your doctor, diabetes educator, or other qualified healthcare professionals. This includes insulin and medication dosing, diet, activity, and any treatment changes. Base those decisions only on readings from a glucose meter or CGM that is legally marketed for this use where you live, never on the App alone.

Never disregard professional medical advice, and never delay seeking it, because of something you saw in the App or on the Website. If you have questions about your health or your treatment, ask your healthcare team.

10. Your responsibility

By using glumea you accept that decisions about your health are made by you and your healthcare team, and that you rely on the App’s information at your own risk. Subject to the paragraph below, and to the limits set out in the liability sections of the Terms of Service, Paweł Milewski Software Development is not liable for decisions that you or anyone else makes based on information shown in the App or on the Website. Our warranty disclaimers and limitations of liability are set out in those sections and apply here in the same way.

Nothing in this Medical Disclaimer or in the Terms of Service excludes or limits any liability that cannot be excluded or limited under applicable law. In particular, nothing here excludes or limits any liability for death, personal injury or harm to your health, however it was caused, our liability for damage we cause you intentionally, our liability for gross negligence, our liability for a defect in the software under product liability law, our liability for fraud or fraudulent misrepresentation, or your rights and remedies under data protection law. Nothing in this Medical Disclaimer or in the Terms of Service limits your mandatory rights under the consumer protection laws of the country where you live, including in the EU and EEA.

11. Language

This Medical Disclaimer is published in English, Russian, Polish and Ukrainian. The English version is the legally binding one. The other three are translations, published so that you can read it in your own language. Where a translation and the English text differ, the English text is the one that governs.

The exception is the law itself. Where the country you live in gives the language you were addressed in a status of its own, as the consumer protection law of several countries does, that rule applies instead of this one, and nothing here takes away a right you have under it.

A translation is published when it is ready, so it can lag behind the English text after an update. If you find a place where a translation and the English text say different things, tell us at [email protected].

12. Contact

Questions about this Medical Disclaimer: [email protected].