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

This small, single-center trial is testing whether the Diabetes M app helps people with Type 1 diabetes calculate their mealtime insulin doses as well as or better than the usual method. All participants will try both approaches in sequence: about two weeks using their normal bolus calculation, then about two weeks using the Diabetes M app. Researchers will compare the glucose data from continuous glucose monitoring (CGM) to see if the app increases time in the target glucose range (roughly 3.9 to 10 mmol/L) and whether it reduces times that glucose is too low or too high.

Who might be eligible: adults 18 to 75 with Type 1 diabetes who are treated with multiple daily injections or an insulin pump and are using CGM, and who have adequate kidney function (eGFR at least 45). Exclusions include having Type 2 diabetes, pregnancy, recent major heart problems, or certain other health issues. If invited and enrolled, you’ll have a screening visit with blood tests, then about four weeks of the study (two weeks with your usual method and two weeks with the Diabetes M app), plus visits to download CGM data and get training on the app. The study aims to see if the app is safe and can improve glucose control, which could support broader use in the future.

Gender

ALL

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.