¿Puede Una aplicación móvil Mejorar el Conocimiento y la autogestión de Las Personas Con Diabetes Tipo 1? Evaluación clínica de la App mySugr

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

Sponsors

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

Collaborator: Roche Diagnostics

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

Overall Status Active, not recruiting
Start Date April 9, 2019
Completion Date April 2021
Primary Completion Date January 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Empowerment Baseline visit and month 12
Secondary Outcome
Measure Time Frame
Adherence to glycemic monitoring Baseline visit and month 3, 6, 9 and 12
Adherence to recommendations Each follow-up visit (month 3, 6, 9 and 12)
Adherence to visits Each follow-up visit (month 3, 6, 9 and 12)
Adherence to the app End of the study (month 12) and 3 months after
Daily management of diabetes Baseline visit and month 12
Quality of life related to diabetes Baseline visit and month 12
Self-efficacy Baseline visit and month 12
Glycemic control Baseline visit and month 3, 6, 9 and 12
Glycemic control Baseline visit and month 6 and 12
Satisfaction with the app End of the study (month 12)
Enrollment 28
Condition
Intervention

Intervention type: Device

Intervention name: mySugr app

Description: 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.

Arm group label: mySugr app

Intervention type: Other

Intervention name: Standard care

Description: Face-to-face visits

Arm group label: Standard care

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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Location
facility Hospital de la Santa Creu i Sant Pau
Location Countries

Spain

Verification Date

June 2020

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Standard care

Arm group type: Active Comparator

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

Arm group label: mySugr app

Arm group type: Experimental

Description: Telemedical assistance with mySugr app

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov