The Effect of Diabetes M Application Use Versus Conventional Bolus Calculation in Patients With Type 1 Diabetes Mellitus

Launched by MEDICAL UNIVERSITY OF SOFIA · May 8, 2025

Keywords

ClinConnect Summary

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 (CSII) or determined insulin:carb ratio (ICR) calculation in multiple daily injections regimen (MDI)) on glycaemic control, measured by time in range (TIR) in percentage defined as time spent in blood glucose levels between 3.9-10.0 mmol/l, in patients with type 1 diabetes on MDI or CSII.

The secondary objectives of this study are: 1) to compare the risk of hypoglycaemic episodes or time below ...

Gender

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Eligibility criteria

• Inclusion Criteria:
• * Subjects are eligible to be included in the trial only if all the following criteria apply:
• • 1. 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.
• • 2. Ability to adhere to the study visit schedule and other protocol requirements.
• • 3. Male or female, age from 18 years to 75 years at the time of signing informed consent.
• • 4. Diagnosed with type 1 diabetes regardless of the disease duration.
• • 5. On treatment with MDI or CSII.
• • 6. Using CGM.
• • 7. eGFR-EPI ≥ 45 ml/min/1.73m 2 .
• Exclusion Criteria:
• * 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.