Status:
ACTIVE_NOT_RECRUITING
The Effect of Diabetes M Application Use Versus Conventional Bolus Calculation in Patients With Type 1 Diabetes Mellitus
Lead Sponsor:
Medical University of Sofia
Collaborating Sponsors:
University Hospital for Active Treatment in Endocrinology "Acad Ivan Penchev" EAD
Sirma Company
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 calcul...
Detailed Description
The primary objective of this study is to compare the effect of Diabetes M application use versus conventional bolus calculation (bolus wizard calculation in continuous subcutateous insulin infusion (...
Eligibility Criteria
Inclusion
- 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 .
Exclusion
- 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.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 8 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06974201
Start Date
April 15 2025
End Date
October 8 2025
Last Update
September 30 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital for Active Treatmnet in Endocrinology "Acad Ivan Penchev" EAD, Medical University of Sofia
Sofia, Bulgaria, 1431