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

NCT06974201 | Active Not Recruiting

• 1 other identifier: Approval № 1/2025 MU Sofia
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes mellitus; bolus calculator

Outcome Measures

Primary Outcomes (1)

• Change from first phase (week 0-2) to second phase (week 3-4) in TIR (%)

  The primary outcome measure is defined as a change in time in range (3.9-10 mmol/l) for glucose between the two estimated periods: the first period without using Diabetes M application for bolus insulin calculation and the second period with using Diabetes M application for bolus insulin calculation.

  From enrollment to the end of treatment at 4 weeks.

Secondary Outcomes (3)

• Change from first phase (week 0-2) to second phase (week 3-4) in TBR (%)

  From enrollment to the end of treatment at 4 weeks.

• Change from first phase (week 0-2) to second phase (week 3-4) in TAR (%)

  From enrollment to the end of treatment at 4 weeks.

• Change from first phase (week 0-2) to second phase (week 3-4) in TITR (%)

  From enrollment to the end of treatment at 4 weeks.

Study Arms (1)

30 subjects with type 1 diabetes on MDI or CSII using CGM

EXPERIMENTAL

All subjects enrolled in the trial will be followed-up for 2-weeks on their usual treatment, meaning calculating their bolus insulin doses using conventional bolus calculators and ratios. Then Diabetes M app will be installed and all subjects will be followed-up for 2-weeks using Diabetes M application for calculating their bolus insulin doses.

Device: Diabetes M bolus calculator; Device: Diabetes M app

Interventions

Diabetes M bolus calculator DEVICE

Diabetes:M Bolus Calculator is an application for precise bolus insulin dose. Full guide for using the Diabetes:M mobile app, can be accessed at * In English https://www.manula.com/manuals/sirma-medical-systems/diabetes-m-user- guide/mobile/en/topic/introduction * In Bulgarian https://www.manula.com/manuals/sirma-medical-systems/diabetes-m-user- guide/mobile/bg/topic/introduction Instructions for the subject Trial participants must use the Diabetes:M Bolus Calculator before every insulin application and must record the insulin units applied. Step-by-step instructions for bolus calculation via Diabetes:M app: 1. Open Diabetes:M app 2. Go to Bolus Advisor 3. Enter blood sugar, carbohydrates 4. Tap Calculate 5. Tap Save button 6. Confirm transferring the bolus to log entry screen 7. Enter note and some feedback if needed 8. Tap Save button to save the record

30 subjects with type 1 diabetes on MDI or CSII using CGM

Diabetes M app DEVICE

Diabetes:M Bolus Calculator is an application for precise bolus insulin dose. Full guide for using the Diabetes:M mobile app, can be accessed at * In English https://www.manula.com/manuals/sirma-medical-systems/diabetes-m-user- guide/mobile/en/topic/introduction * In Bulgarian https://www.manula.com/manuals/sirma-medical-systems/diabetes-m-user- guide/mobile/bg/topic/introduction Instructions for the subject Trial participants must use the Diabetes:M Bolus Calculator before every insulin application and must record the insulin units applied. Step-by-step instructions for bolus calculation via Diabetes:M app: 1. Open Diabetes:M app 2. Go to Bolus Advisor 3. Enter blood sugar, carbohydrates 4. Tap Calculate 5. Tap Save button 6. Confirm transferring the bolus to log entry screen 7. Enter note and some feedback if needed 8. Tap Save button to save the record

30 subjects with type 1 diabetes on MDI or CSII using CGM

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• Subjects are excluded from the trial if any of the following criteria apply:
• Diabetes related
• \. 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.
• \. 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.

Sponsors & Collaborators

• Medical University of Sofia: lead
• University Hospital for Active Treatment in Endocrinology "Acad Ivan Penchev" EAD: collaborator
• Sirma Company: collaborator

Study Sites (1)

University Hospital for Active Treatmnet in Endocrinology "Acad Ivan Penchev" EAD, Medical University of Sofia

Sofia, 1431, Bulgaria

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 15, 2025
• Study Start: April 15, 2025
• Primary Completion: October 8, 2025
• Study Completion: October 8, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)