Clinical trial NCT03819335: ¿Can mySugr App Improve Knowledge and Self-management of People With Type 1 Diabetes Mellitus?
Official title: ¿Puede Una aplicación móvil Mejorar el Conocimiento y la autogestión de Las Personas Con Diabetes Tipo 1? Evaluación clínica de la App mySugr
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus, Type 1
Mobile Applications
Telemedicine
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2019-01-28
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Empowerment
timeFrame: Baseline visit and month 12
Secondary outcomes:
measure: Adherence to glycemic monitoring
timeFrame: Baseline visit and month 3, 6, 9 and 12
measure: Adherence to recommendations
timeFrame: Each follow-up visit (month 3, 6, 9 and 12)
measure: Adherence to visits
timeFrame: Each follow-up visit (month 3, 6, 9 and 12)
measure: Adherence to the app
timeFrame: End of the study (month 12) and 3 months after
measure: Daily management of diabetes
timeFrame: Baseline visit and month 12
measure: Quality of life related to diabetes
timeFrame: Baseline visit and month 12
measure: Self-efficacy
timeFrame: Baseline visit and month 12
measure: Glycemic control
timeFrame: Baseline visit and month 3, 6, 9 and 12
measure: Glycemic control
timeFrame: Baseline visit and month 6 and 12
measure: Satisfaction with the app
timeFrame: End of the study (month 12)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References: