¿Can mySugr App Improve Knowledge and Self-management of People With Type 1 Diabetes Mellitus?

NCT ID: NCT03819335

Last Updated: 2021-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-09
• Study Completion Date: 2021-04-13

Brief Summary

This project is based on the contribution that an app can offer for improving knowledge and self-management of people with type 1 diabetes.

The main objective of this study is to assess mySugr app as a tool for empowering people with type 1 diabetes.

The study population are type 1 diabetes people, aged more than 18 years old and with more than one year from diagnosis. They will be randomised to standard care or use of mySugr app and will be followed-up during 48 weeks.

Control group will attend 5 face-to-face visits (baseline, 3, 6, 9 and 12 months) with the possibility of telephone contact and hospital assistance if necessary. Intervention group will attend 3 face-to-face visits (baseline, 6 and 12 months) and 2 telematic visits (at 3 and 9 months) and will also have the possibility of telephone contact and hospital assistance if necessary.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard care

Usual follow-up of diabetes type 1 with face-to-face visits

Group Type: ACTIVE_COMPARATOR

Standard care

Intervention Type: OTHER

Face-to-face visits

mySugr app

Telemedical assistance with mySugr app

Group Type: EXPERIMENTAL

mySugr app

Intervention Type: DEVICE

mySugr is a mobile medical app for diabetes management. It has been developed by Roche Diabetes Care and it has two versions, free and Pro. It allows to carry out the diary of diabetes, including the collection and analysis of data on glycaemia, food, physical activity or insulin dose. In addition, it is compatible with continuous glucose measurement systems. It has the possibility to add functionalities such as estimation of HbA1c levels, more detailed data analysis or integration with Google Fit type motion sensors, as well as a bolus calculator, reminders for measuring blood glucose or photo gallery in the Pro version, which is the one that will be provided to the patients for the study.

Interventions

mySugr app

mySugr is a mobile medical app for diabetes management. It has been developed by Roche Diabetes Care and it has two versions, free and Pro. It allows to carry out the diary of diabetes, including the collection and analysis of data on glycaemia, food, physical activity or insulin dose. In addition, it is compatible with continuous glucose measurement systems. It has the possibility to add functionalities such as estimation of HbA1c levels, more detailed data analysis or integration with Google Fit type motion sensors, as well as a bolus calculator, reminders for measuring blood glucose or photo gallery in the Pro version, which is the one that will be provided to the patients for the study.

Intervention Type: DEVICE

Standard care

Face-to-face visits

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients over 18 years of age
• People with type 1 diabetes (> 1 year diagnosis)
• Treatment with insulin in basal-bolus regimen
• Glucometer that connects automatically with the app
• HbA1c 7-9%
• Understanding of carbohydrate counting and concepts of ratio and factor of sensitivity
• Have a smartphone or tablet

Exclusion Criteria

• Use at the time of randomization of another app for diabetes management
• Use of continuous monitoring or flash glucose systems
• Pregnancy
• Any other disease or condition that may interfere with the completion of the protocol or completion of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Diagnostics GmbH

INDUSTRY

Sponsor Role: collaborator

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Countries

Spain

References

Cuixart G, Corcoy R, Gonzalez C. Can a mobile application improve glucose-related and patient-reported outcome measures (PROMs) in people with type 1 diabetes mellitus? A randomized controlled trial using the mySugr(R) app. Hormones (Athens). 2025 Mar;24(1):137-147. doi: 10.1007/s42000-024-00609-z. Epub 2024 Oct 16.

Reference Type: DERIVED

PMID: 39412732 (View on PubMed)

Other Identifiers

IIBSP-SUG-2018-01

Identifier Type: -

Identifier Source: org_study_id