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

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

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: mySugr app; Other: Standard care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03819335

IIBSP-SUG-2018-01

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Standard care

Active Comparator group

Description:

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

Treatment:

Other: Standard care

mySugr app

Experimental group

Description:

Telemedical assistance with mySugr app

Treatment:

Device: mySugr app