Sirma Medical Systems Launches Key Clinical Trial of Its Diabetes:M Bolus Calculator

Sirma Medical Systems, a member of the DHI Cluster, has announced the launch of a clinical trial at the Endocrinology Clinic of the Medical University of Sofia. The aim is to validate the patented Diabetes:M bolus calculator - an innovative digital tool designed to support people with type 1 diabetes in calculating accurate insulin doses and achieving better glycemic control.

Type 1 diabetes requires daily and precise insulin dosing - a challenge that remains even with the use of modern technologies such as continuous glucose monitoring (CGM) systems and insulin pumps. This is where the Diabetes:M bolus calculator provides a solution: it integrates data such as insulin-to-carbohydrate ratios, sensitivity factors, insulin action time, and glucose targets to deliver more accurate and safer calculations.

The app consistently ranks in the top 5 diabetes apps worldwide, with more than 1 million downloads and over 50,000 active monthly users. Diabetes:M supports integration with more than 16 glucometers, including Nipro 4SURE Smart, SmartDuo, and AktivMed GlucoCheck GOLD, and regularly introduces new AI functionalities to help patients manage their condition in everyday life.

The clinical trial will compare the effectiveness of the bolus calculator against traditional insulin dosing methods. Its main objective is to measure improvements in the percentage of time patients spend within their target glucose range (Time in Range).

Below are excerpts from our conversation with Rossen Varbanov, CEO of Sirma Medical Systems, in which he shares insights into the challenges, significance, and future of this innovation:

What specific challenges do you face when developing and validating medical software of this kind?

Medical software is under a magnifying glass - it requires much higher standards for quality, security, and traceability than an ordinary app. We must prove that it works reliably and safely, that it protects sensitive data, and that it is easy to use. An additional challenge is that digital health regulations are evolving dynamically across countries, and we need to stay one step ahead – integrating devices, testing in real conditions, and meeting the expectations of both patients and doctors. This makes the process slower, but it also ensures greater safety and trust.

How does this tool change the lives of people with type 1 diabetes - both in Bulgaria and globally?

Diabetes:M helps people with T1D make daily decisions more calmly and confidently - from meals and dosing to exercise and travel. The app collects and visualizes data, shows trends, and facilitates communication with healthcare professionals. Through the connected Diabetes:M Monitor, family members and clinicians can track the condition in real time, bringing more security and better-informed therapy adjustments. Most importantly, the tool adapts to the patient’s daily life and works with various devices, instead of forcing them to change their habits.

Is there already international interest or partnerships related to expanding the product beyond Bulgaria?

Yes, international interest has existed since the very beginning. Over the years, we have built a strong network of partnerships across different markets. Diabetes:M is one of the few independent solutions, we are not tied to a large pharmaceutical company or a specific device manufacturer. This gives us the freedom to integrate multiple brands and work with the most suitable partners for each region. We have long-standing collaborations with pharma companies, device manufacturers, universities, and numerous hospitals and clinics worldwide.

What are the next steps for the bolus calculator after the clinical trial concludes?

Once the trial is completed, we will summarize the results, finalize the documentation, and submit the necessary applications for regulatory approvals. We plan to gradually introduce the calculator into the app with clear instructions and safeguards to ensure it is as safe and user-friendly as possible. After launch, we will closely monitor real-world use and continue improving the tool, including its integration with different devices and personalization according to each patient’s profile.

What role does your participation in DHI Cluster play in the development of this project and your digital innovations?

The Cluster gives us broader access to experts from hospitals, industry, and academia, accelerating the transformation of ideas into working solutions. It strengthens our voice before institutions, eases access to pilot projects and partnerships, and increases visibility. Thanks to this ecosystem, we shorten the path from a “good idea” to a proven, safe, and scalable digital innovation.