Sofia, Bulgaria — 17.07.2025 — Sirma Medical Systems announces the launch of an IRB approved clinical study evaluating the Diabetes:M Bolus Calculator. The Diabetes:M Bolus Calculator is Sirma’s proprietary implementation of a digital solution designed to enhance glycemic control in individuals with type 1 diabetes. The study is being conducted at the Endocrinology Department at the Medical University of Sofia. The principal investigator is Associate Professor Dr. Rumyana Dimova-Draganova. The study endpoints, aim to assess the effectiveness of the Diabetes:M application compared to traditional bolus insulin dose calculations.
Type 1 diabetes, an autoimmune disease affecting about 10% of the diabetic population, requires precise insulin dosing to maintain optimal blood glucose levels. This clinical trial seeks to demonstrate the potential benefits of Diabetes:M’s bolus calculator. It is designed to simplify and improve the accuracy of insulin dosing for patients using multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) therapies.
The primary objective of the study is to measure improvements in glycemic control by comparing the percentage of time patients spend within a targeted blood glucose range (3.9–10.0 mmol/l). Secondary outcomes will evaluate reductions in both hypoglycemic (low blood glucose) and hyperglycemic (high blood glucose) episodes, as well as time spent within a tighter glucose range (3.9–7.8 mmol/l).
This clinical study represents a cornerstone for achieving better regulatory adherence and acceptance across international markets. Positive results from rigorous clinical evaluation will facilitate the official approval of the Diabetes:M Bolus Calculator in various regions, streamlining patient access and enhancing global diabetes management standards.
“Accurate bolus insulin calculation remains a significant challenge for people managing type 1 diabetes,” said Dr. Dimova-Draganova. “Our goal with this study is to validate the Diabetes:M Bolus Calculator’s effectiveness and safety, potentially transforming daily diabetes management and significantly enhancing patients’ quality of life.”
Rossen Varbanov, CEO of Sirma Medical Systems, emphasized the significance of this initiative: “This study is a critical step toward achieving our mission to innovate diabetes management globally. We believe the Diabetes:M Bolus Calculator has the potential to become an essential tool in daily diabetes care, greatly improving adherence and health outcomes for patients worldwide.”
The Diabetes:M Bolus Calculator incorporates key variables including insulin-to-carbohydrate ratios, insulin sensitivity factors, active insulin time, and target glucose levels, accompanied by multiple built-in safety features. Upon successful completion and positive outcomes of the trial, the application will be officially registered, ensuring wide availability for patients globally.
Given that more than half of patients with type 1 diabetes still experience suboptimal glucose control despite advancements such as continuous glucose monitoring and insulin pump technologies, tools like Diabetes:M offer an essential additional resource for improving health outcomes.
