NCT06974201Active, not recruiting
The Effect of Diabetes M Application Use Versus Conventional Bolus Calculation in Patients With Type 1 Diabetes Mellitus
An Open Label Study to Determine the Effect of Diabetes M Application Use Versus Conventional Bolus Calculation in Patients With Type 1 Diabetes Mellitus on MDI or CSII
Source: ClinicalTrials.gov · Last updated 30 Sept 2025
Brief summary (registry, in English)
Managing insulin dosing for diabetes, particularly for those with type 1 diabetes mellitus, is a complex process that requires precision. Insulin bolus calculators are designed to help patients calculate their insulin needs based on variables such as carbohydrate intake, blood glucose levels, and insulin sensitivity. However, to ensure these tools are safe and effective, clinical trials are essential. The primary purpose of this trial is to assess the safety and efficacy of the bolus calculator - Diabetes M in providing accurate insulin dosing and preventing the risk of hypoglycemia and hyperglycemia, which can lead to severe complications. The clinical trial is critical to ensure patient's safety and build confidence in the use of the bolus insulin calculator in real-world settings. Insulin dosing errors, whether too high or too low, can lead to serious health risks, including hypoglycemia, hyperglycemia, and long-term diabetes complications. By conducting a controlled study, the trial will evaluate how well the bolus calculator performs in preventing these risks, comparing its recommendations to standard practices. This will help determine whether the calculator can consistently improve blood glucose management while minimizing human error in insulin dosing decisions. Finally, regulatory approval from bodies like the Food and Drug Administration (FDA) requires clear evidence of safety and efficacy. The data from this clinical trial will not only support regulatory submissions but also demonstrate the bolus calculator's clinical utility in improving outcomes like glycemic control and patient compliance. By empowering patients to make more informed dosing decisions and reducing the complexity of diabetes management, this trial could pave the way for broader adoption of this technology and ultimately improve the quality of life for patients with type 1 diabetes mellitus.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 21 Apr 2025
- Start date
- 15 Apr 2025
- Primary completion date
- 8 Oct 2025
- Lead sponsor
- Medical University of Sofia
- Diseases
- Type 1 diabetes
- NCT number
- NCT06974201
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 15 Apr 2025 to the primary completion date, 8 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Subjects are excluded from the trial if any of the following criteria apply:
- Diabetes related
- 1\. Male or female, age \< 18 years or \> 75 years. 2. Diagnosed with type 2 diabetes. 3. Diagnosed with diabetes proliferative retinopathy. 4. Renal impairment measured as estimated glomerular filtration rate (eGFR-EPI) value of \< 45 mL/min/1.73 m 2 according to KDIGO. 5. Frequent severe hypoglycaemic episodes (\<3.5 mmol/l). 6. Any acute illnesses, which might influence glycaemic control in short term. General safety 8. Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 3 months prior to the day of screening. 9. Presently classified as being in New York Heart Association (NYHA) Class IV. 10. Presence or history of malignant neoplasm within 5 years prior to the day of screening.
- 11\. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. 12. Any disorder, unwillingness or inability, which in the investigator's opinion, might jeopardise the subject's safety or compliance with the protocol.
Who the study is looking for
- Subjects are eligible to be included in the trial only if all the following criteria apply:
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- Ability to adhere to the study visit schedule and other protocol requirements.
- Male or female, age from 18 years to 75 years at the time of signing informed consent.
- Diagnosed with type 1 diabetes regardless of the disease duration.
- On treatment with MDI or CSII.
- Using CGM.
- eGFR-EPI ≥ 45 ml/min/1.73m 2 .
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital for Active Treatmnet in Endocrinology "Acad Ivan Penchev" EAD, Medical University of Sofia Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.