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

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

Interventions

DEVICE

Diabetes M bolus calculator

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

DEVICE

Diabetes M app

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

Sponsors & Collaborators

• University Hospital for Active Treatment in Endocrinology "Acad Ivan Penchev" EAD

  collaborator UNKNOWN

• Sirma Company

  collaborator UNKNOWN

• Medical University of Sofia

  lead OTHER

Study Design

Allocation

NA

Purpose

OTHER

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-15

Primary Completion

2025-10-08

Completion

2025-10-08

Countries

• Bulgaria

Study Locations