Count My Carbs

About this document

This document is the Instructions for Use (IFU) for the Count My Carbs mobile application, a medical device manufactured by Takeover Interactive Ltd. It describes the intended purpose of the device, who it is and is not for, how to set it up and use it safely, its limitations, and how to report any concerns.

Read this document in full before using Count My Carbs for the first time. Keep it accessible for reference. The current version is always published at countmycarbs.co.uk/ifu.

Device identification

Product name

Count My Carbs — Full Mode (Insulin Dose Calculator)

Device type

Software as a Medical Device (SaMD)

Classification

Class I, UK Medical Devices Regulations 2002 (SI 2002 No. 618, as amended). Confirmed by MHRA correspondence ref SG/2025/11/04/06, 20 November 2025.

Conformity mark

UKCA

GMDN code

66082 — Diabetes patient management software

MHRA registration

Account 0000037996

Declaration of Conformity

DOC-TAKEOVER-001 Rev 1.0, dated April 2026

Manufacturer

Takeover Interactive Ltd, 225 Marsh Wall, Canary Wharf, London E14 9FW, United Kingdom · Companies House 09045814

Standards applied

ISO 14971:2019 (Risk management) · IEC 62304:2006+A1:2015 (Software lifecycle)

Data protection

UK GDPR / Data Protection Act 2018 — DPIA on file

Software version

Displayed in-app at Settings > About > Software version

Intended purpose

Count My Carbs is intended to assist adults with Type 1 diabetes in calculating personalised insulin bolus doses for meals. The calculation considers carbohydrate intake, current blood glucose, insulin-to-carbohydrate ratio, insulin sensitivity factor, insulin-on-board, exercise, hormonal factors, stress and sleep, meal composition, and other physiological variables prescribed or configured by the user's healthcare provider.

The device provides dose recommendations only. The user reviews, may modify, and manually administers all insulin doses. The device does not automatically deliver insulin or make autonomous treatment decisions.

Indications and contraindications

Indications

Count My Carbs is indicated for:

• Adults aged 18 years or older diagnosed with Type 1 diabetes
• Persons on multiple daily injection (MDI) therapy or insulin pump therapy
• Persons whose dosing parameters (carbohydrate ratio, insulin sensitivity factor, target glucose range) have been prescribed or approved by a qualified healthcare provider
• Persons capable of independent decision-making regarding their own insulin administration

Contraindications

Count My Carbs is not intended for:

• Persons with Type 2 diabetes
• Persons with gestational diabetes or pregnancy
• Persons with other forms of diabetes (e.g. MODY, secondary diabetes)
• Persons under 18 years of age
• Use as an autonomous decision-making system — every dose requires user review and manual administration
• Driving or controlling insulin pumps. The device does not communicate with, control, or instruct insulin pumps.
• Diagnosing diabetes or any other medical condition
• Emergency medical decision-making

Warnings and precautions

Dosing parameters must be prescribed or approved by your healthcare provider. Carbohydrate ratios, insulin sensitivity factors and target glucose ranges should not be changed without medical guidance. Inappropriate values may lead to dangerously high or low blood glucose.

Hypoglycaemia and hyperglycaemia. Incorrect doses may result in hypoglycaemia (low blood glucose), which can cause confusion, seizures, loss of consciousness or, in severe cases, death. Persistent hyperglycaemia (high blood glucose) may lead to diabetic ketoacidosis (DKA), which is a medical emergency. Recognise the symptoms and act on them — do not rely solely on the app.

Estimates are estimates. Food recognition, barcode lookups and food database results provide estimates of carbohydrate, fat and protein content. Actual nutritional content may vary, particularly for home-cooked meals and unbranded foods. Adjust your portion size or override the recommendation if you have better information.

Manual entry of glucose values. All blood glucose values used by the app are entered manually by you. Errors in entry (e.g. entering a glucose value with the wrong unit or transposed digits) will produce incorrect dose recommendations. Confirm the value displayed before continuing.

Health platform data accuracy. Activity, heart rate, sleep and other physiological data are read from Apple Health or Health Connect. The accuracy of these data depends on the source device (smartwatch, fitness tracker) and the underlying health platform. Inaccurate health data may result in inappropriate activity adjustments.

Do not delay treatment of suspected hypoglycaemia. If you experience symptoms of low blood glucose, treat them immediately according to your healthcare provider's instructions. Do not wait for the app to confirm a value.

Do not use during a medical emergency. If you are unwell, vomiting, in suspected DKA, or experiencing symptoms requiring urgent care, seek immediate medical attention. Contact your diabetes team, NHS 111, or emergency services as appropriate. Do not rely on the app.

Software updates. Keep Count My Carbs up to date. Updates may include safety improvements, calculation refinements and bug fixes. Operating system updates may also affect compatibility.

Device security. Protect your phone with a passcode and enable the in-app biometric lock. Loss or theft of an unlocked device with the app installed could expose sensitive health data.

System requirements

• iOS: iOS 15 or later. iPhone with camera (for food recognition and barcode scanning). Face ID or Touch ID for biometric lock (optional).
• Android: Android 10 (API 29) or later. Camera. Google Play Services and Health Connect installed. Fingerprint or face unlock for biometric lock (optional).
• Internet: An active internet connection is required for AI food recognition, barcode database lookups, account features and data sync. The app retains a recently used food cache for offline use of previously logged items.
• Storage: Approximately 250 MB free storage.
• Account: A Count My Carbs account, created in-app, is required.

Setting up the device

The first-time setup process is guided. The following parameters must be available before you begin, and should be prescribed or approved by your healthcare provider:

• Diabetes type and diagnosis date
• Insulin type and delivery method (MDI or pump)
• Insulin-to-carbohydrate ratio (units of insulin per gram of carbohydrate, often expressed as 1: x g)
• Insulin sensitivity factor / correction factor (mmol/L or mg/dL drop per unit of insulin)
• Target blood glucose range
• Insulin duration of action (typically 3–5 hours for rapid-acting analogues)
• Maximum permitted single dose, if recommended by your team

Steps:

1. Download Count My Carbs from the Apple App Store or Google Play.
2. Create an account using your email address. Verify your email.
3. Read and accept the Terms of Service, Privacy Policy and required consents.
4. Choose your mode — Simple Mode (carb counting only) or Full Insulin Management.
5. Enter your personal profile (name, date of birth, sex, height, weight).
6. Enter your diabetes details and dosing parameters (above).
7. Set your preferred glucose unit (mmol/L or mg/dL).
8. Configure optional features: biometric lock, notifications, health platform connection.
9. Review the on-screen safety notices before first calculation.

If your diabetes team has provided you with a configuration code or invitation link, enter or follow it during setup to receive your team's recommended parameters automatically. Parameters set this way may be locked from user modification.

Logging a meal

From the main screen, choose one of the following methods:

• Photograph the meal. Tap the camera icon, frame the plate, and capture. The AI food recognition service returns an estimated breakdown of foods, carbohydrates, fat and protein. Review each item and adjust portions as needed.
• Scan a barcode. Tap the barcode icon and point your camera at the product barcode. The food database returns the nutritional information per serving. Adjust the serving size to match what you are eating.
• Search by name. Tap the search icon and type a food name. Choose the closest match from the results and adjust serving size.
• Repeat a recent meal. Open your meal history, find a previous meal, and add it to the current log.

You can combine methods within a single meal (for example, photograph the plate and add a packaged drink by barcode).

Once your meal is complete, tap the calculate button. The app will check the freshness of your most recent glucose reading (see §9) and proceed to the dose recommendation screen.

Entering glucose readings

All blood glucose readings used by Count My Carbs are entered manually. The app does not receive readings from external continuous glucose monitors, flash glucose sensors or in-vitro diagnostic devices.

How to enter a reading

You can log a glucose reading at any time:

• From the main screen, tap the glucose entry button
• Type your current blood glucose value in your configured unit (mmol/L or mg/dL)
• Confirm the value before saving

The 15-minute freshness rule

This check exists because insulin dose recommendations are only meaningful in relation to your current blood glucose. A glucose value taken an hour ago, or two hours ago, may bear little resemblance to your current value — and a dose calculated against a stale reading could lead to hypoglycaemia or hyperglycaemia.

When the freshness check fires:

1. Take a fingerstick blood glucose measurement, or read your flash sensor
2. Enter the value when prompted
3. Confirm and continue to the dose recommendation

You may also enter a glucose reading proactively from the main screen — before, during or after a meal — and the most recent value will be used.

Check the unit. Confirm that the unit displayed (mmol/L or mg/dL) matches your meter's unit. A misread between units can produce a dose recommendation that is dangerously wrong (for example, entering 100 in mmol/L when you meant 100 in mg/dL would represent a clinically impossible value and may be rejected by the input range; entering 5.5 in mg/dL when you meant 5.5 mmol/L would be interpreted as severe hypoglycaemia).

How the dose is calculated

The bolus dose recommendation is built from the following inputs:

• Carbohydrate dose — calculated from the total carbohydrate intake of the logged meal divided by your insulin-to-carbohydrate ratio.
• Correction dose — calculated from the difference between your current blood glucose and your target glucose, divided by your insulin sensitivity factor. If your glucose is at or below target, no correction is added; if it is significantly below target, the dose may be reduced.
• Insulin-on-board (IOB) — the residual insulin activity from previous bolus doses, based on the insulin duration of action you have configured. IOB is subtracted from the recommendation to prevent dose stacking. See §11.
• Fat and protein units (FPU) — for meals high in fat or protein, the calculator may recommend an additional split or delayed dose to account for slower glycaemic impact. This feature must be enabled in settings.
• Activity adjustment — derived from recent activity, heart rate, and recovery data read from Apple Health or Health Connect. Recent or planned exercise may reduce the recommended dose. See §12.
• Hormonal, stress and sleep adjustments — derived from menstrual cycle phase, HRV, and sleep stage data when available. See §12.

The recommendation screen shows the full calculation breakdown. You can:

• Review the components and the reasoning
• Adjust the recommendation manually if your clinical judgement differs
• Confirm and log the dose you actually administer
• Cancel and re-calculate, or abandon the calculation entirely

The dose recommendation is always presented with the calculation breakdown visible. The app will not display a final dose number without the supporting components.

Safety features

Glucose freshness check

Before each meal calculation, the app verifies that your most recent glucose reading is within 15 minutes. Stale readings block calculation until refreshed. See §9.

Insulin-on-board and dose stacking protection

The app tracks active insulin from previous doses across the configured duration of action. Active insulin is subtracted from the recommendation, reducing the risk of stacked doses leading to hypoglycaemia. Recent doses are visible in the IOB display.

Maximum dose caps

If a maximum single dose has been configured for you by your diabetes team, dose recommendations exceeding this cap are flagged and require confirmation. Caps can be configured under Settings > Insulin > Maximum dose, or remotely by your team if HCP configuration is in use.

Hypoglycaemia recognition and treatment guidance

When you enter a blood glucose value below your configured hypo threshold, the app displays a hypoglycaemia alert with carbohydrate treatment guidance. Bolus calculation is suppressed until your glucose is safely above the threshold.

Ketone-aware exercise blocking

If you have logged elevated blood ketone levels, the app suppresses activity-related dose reductions and warns against exercise. Refer to your sick-day rules and contact your diabetes team if ketones are present with persistently high glucose.

Calculation transparency

Every dose recommendation is presented with the full calculation visible. No "black box" recommendations are displayed.

Pre-bolus timing

When pre-bolus timing is recommended (based on your current glucose, meal type and configured insulin onset), the app displays a countdown and reminder before suggesting administration.

Activity and physiological factors

Count My Carbs reads physiological data from your phone's health platform (Apple Health on iOS, Health Connect on Android) to refine dose recommendations. You control which data types are shared in your phone's health permissions.

Activity

Steps, exercise sessions, heart rate during workouts and active energy are used to detect physical activity that may have increased insulin sensitivity. Recent or planned activity can reduce the recommended dose. Persistent low activity may be reflected in baseline adjustments.

Sleep and recovery

Sleep duration, sleep stages, resting heart rate and heart rate variability (HRV) are used to estimate physiological recovery and stress load, both of which can affect insulin sensitivity.

Hormonal factors

If menstrual cycle tracking is enabled in your health platform, the app may apply phase-dependent adjustments based on the typical insulin resistance pattern across the cycle. Dawn phenomenon adjustments are based on observed glucose patterns and your configured profile.

Overriding adjustments

All physiological adjustments are visible in the calculation breakdown and can be reviewed before you accept a recommendation. If you disagree with an adjustment, you can modify the recommended dose manually before logging it.

Pump bolus recommendations

If you use an insulin pump, you can configure your pump model in the app to receive recommendations expressed in the format and increments your pump uses. The app may also present split-dose or extended-bolus recommendations appropriate for your pump.

Limitations

• Count My Carbs is not validated for Type 2 diabetes, gestational diabetes, secondary or atypical diabetes.
• It is not validated for use in children or adolescents under 18.
• It does not diagnose hypoglycaemia, hyperglycaemia, DKA or any other condition. It may flag these conditions based on your inputs but is not a diagnostic device.
• AI food recognition produces estimates and may be incorrect, particularly for mixed dishes, home-cooked food, regional cuisines under-represented in training data, or unusual presentations.
• Barcode and food database results depend on the underlying databases and may contain errors or out-of-date nutritional information.
• Activity and physiological adjustments rely on the accuracy of the source devices (e.g. smartwatch, fitness tracker). If these are inaccurate, the adjustment will be inaccurate.
• The app does not detect glucose meter or sensor errors. It assumes the value you enter is the value your meter or sensor showed.
• The app does not replace clinical judgement and is not intended for use in emergency situations.

Data protection

Count My Carbs processes personal and health data under UK GDPR and the Data Protection Act 2018. The lawful basis, categories of data processed, retention periods and your rights are described in the Privacy Policy at countmycarbs.co.uk/privacy-policy. A Data Protection Impact Assessment has been completed and is on file.

Key points:

• Your health data is encrypted in transit and at rest.
• You can export or permanently delete all your data at any time from Settings > GDPR / Account.
• Your data is never sold.
• Food images you capture are sent to a third-party AI provider for analysis; the privacy policy describes this in detail.
• You may enable a biometric lock to require Face ID, Touch ID or fingerprint authentication on each app launch.

Reporting concerns and incidents

If you experience a problem with Count My Carbs that you believe may have affected your safety, or that of someone else — for example, a dose recommendation that appears clearly wrong, an unexpected app crash during a calculation, or any other issue with potential clinical impact — please report it to us as soon as possible.

How to report

Email [email protected] or [email protected] with:

• A description of what happened
• The date and approximate time
• The app version (visible at Settings > About)
• Your phone model and operating system
• Whether anyone was harmed and how

MHRA Yellow Card scheme

You can also report adverse incidents involving medical devices directly to the Medicines and Healthcare products Regulatory Agency (MHRA) through the Yellow Card scheme:

yellowcard.mhra.gov.uk

In a medical emergency

Do not rely on this app or this reporting process. Call 999, attend A&E, or contact your diabetes team or NHS 111 as appropriate.

Troubleshooting

The app keeps asking for a fresh glucose reading

This is expected behaviour. If your most recent reading is more than 15 minutes old, the app requires a fresh entry before calculating a dose. Take a fingerstick reading or scan your flash sensor and enter the value.

Food recognition gave an inaccurate carbohydrate estimate

Adjust portion sizes or replace the recognised item via search before calculating. AI food recognition is an estimate and may miss ingredients, especially in mixed dishes or under poor lighting. If you have packaging, scan the barcode for the most accurate value.

Activity data isn't being read

Open your phone's health settings (Apple Health or Health Connect) and confirm Count My Carbs has permission to read the relevant data types. The app needs read access to steps, heart rate, workouts, sleep and HRV for the full activity adjustment.

I forgot my password

Use the password reset flow on the login screen. A reset link is sent to your registered email.

The app crashed

Force-quit and reopen the app. If it crashes again, ensure your operating system and the app are up to date. If the problem persists, contact support at [email protected].

I disagree with a dose recommendation

You can always adjust the recommended dose before confirming. Use your clinical judgement and your diabetes team's advice. If you regularly find the recommendations significantly off, contact your diabetes team to review the dosing parameters you have configured.

Symbols used

The following marks and labels appear in the app or on packaging, in line with BS EN ISO 15223-1.

Manufacturer information

Legal manufacturer

Takeover Interactive Ltd

Registered office

225 Marsh Wall, Canary Wharf, London E14 9FW, United Kingdom

Companies House

09045814

MHRA registration

Account 0000037996

General enquiries

[email protected]

Safety and incident reporting

[email protected]

Website

countmycarbs.co.uk

Declaration of Conformity

DOC-TAKEOVER-001 — available on request

Document control

Document reference

IFU-CMC-001

Revision

1.0

Date of issue

May 2026

Applies to software

Count My Carbs v1.0 and later until superseded

Owner

Takeover Interactive Ltd — Regulatory Affairs

Review cycle

Annual, or upon material change to the device, its intended use, or applicable regulations

Supersedes

—

This document is published electronically at countmycarbs.co.uk/ifu. A printable PDF copy is available on request from [email protected]. The electronic version is the authoritative version; printed copies should be checked against the published version before use.