Core Technology: Dynamic Insulin Titration

At the heart of Diafyt's offerings is its proprietary, self-learning algorithm designed for dynamic insulin titration. Traditional insulin calculators rely on static factors (such as fixed insulin-to-carb ratios and correction factors) configured by a physician during clinic visits. However, human metabolism is highly dynamic, influenced by stress, physical activity, illness, and hormonal fluctuations.

Diafyt's technology overcomes these limitations by: * Adaptive Learning: The algorithm continuously analyzes patient data, including blood glucose levels, carbohydrate intake, and administered insulin doses, to learn the user's specific insulin sensitivity at different times of the day. * Predictive Modeling: It predicts future blood glucose trends and simulates metabolic responses to calculate the optimal bolus (mealtime) and basal (long-acting) insulin doses. * Autocalibration: The system automatically adjusts its internal calculation parameters based on historical treatment outcomes, reducing the need for manual, frequent adjustments by healthcare providers.

Products and Services

Diafyt translates its advanced algorithmic technology into practical, certified medical software products tailored for both patients and healthcare professionals.

1. The Diafyt App (Patient-Facing Solution)

The Diafyt App is a mobile application designed for individuals requiring daily insulin injections (multiple daily injection therapy, or MDI). It acts as an intelligent digital companion, offering the following features:

• AI-Powered Bolus Calculator: Users input their current blood glucose value and planned carbohydrate intake. The app then calculates the exact recommended dose of rapid-acting insulin.
• Basal Insulin Optimization: The app assists users in optimizing their long-acting background insulin, guiding them safely toward their target fasting glucose levels without inducing hypoglycemia.
• Seamless Device Integration: The app integrates with continuous glucose monitoring (CGM) systems and Bluetooth-enabled blood glucose meters (BGM) to automatically import glucose readings, minimizing manual entry errors.
• Digital Logbook and Analytics: It automatically logs glucose levels, insulin doses, carbohydrates, and activities. The app visualizes this data in easy-to-read charts, highlighting patterns, time-in-range (TIR), and estimated HbA1c values.

2. Diafyt Clinical Portal (Provider-Facing Solution)

For healthcare professionals (HCPs), Diafyt offers a secure cloud-based clinical portal that streamlines patient management and remote monitoring:

• Remote Data Monitoring: Physicians and diabetes educators can access real-time, structured patient data, eliminating the need for manual logbook reviews during consultations.
• Therapy Insights: The portal flags high-risk patients, such as those experiencing frequent hypoglycemic episodes or severe glucose variability, allowing clinical teams to prioritize interventions.
• Treatment Plan Optimization: HCPs can review the adjustments made by the Diafyt algorithm, verify patient compliance, and collaborate with the patient to fine-tune therapy goals.

3. B2B Algorithmic Integration & Licensing (OEM Solutions)

Recognizing the value of its proprietary software, Diafyt offers its calculation engine as an open API (Application Programming Interface) or software development kit (SDK) for integration into third-party platforms. Target partners include: * Insulin Pen Manufacturers: Enabling smart insulin pens to recommend doses directly on a built-in screen or companion app. * CGM Manufacturers: Embedding titration intelligence directly into glucose monitoring software. * Telehealth Platforms: Enhancing existing digital health ecosystems with certified clinical decision support tools for diabetes.

Target Audience and Clinical Impact

Diafyt’s solutions address critical pain points across the entire diabetes care ecosystem:

• For Patients: It reduces the daily anxiety associated with calculating insulin doses, lowers the risk of severe hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar), and improves overall quality of life.
• For Clinicians: It provides actionable data insights, saves time during clinical consultations, and enables safe, proactive remote patient management (telemedicine).
• For Payers (Health Insurance Providers): By improving long-term glycemic control and preventing acute complications (such as diabetic ketoacidosis or severe hypoglycemia requiring hospitalization), Diafyt helps reduce the substantial economic burden associated with diabetes care.

Regulatory Compliance and Data Security

As a developer of digital therapeutics and medical software, Diafyt prioritizes rigorous regulatory standards and data protection:

• CE Mark Certification: Diafyt’s software is developed and certified as a medical device in accordance with European medical device regulations (MDR), ensuring clinical safety, efficacy, and software reliability.
• GDPR Compliance: Operating primarily out of Germany, the company adheres to strict General Data Protection Regulation (GDPR) standards. Patient data is encrypted both in transit and at rest, and hosted on secure, certified medical-grade servers.