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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: mySugr app
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care<br>Usual follow-up of diabetes type 1 with face-to-face visits | Other: Standard care<br>* Face-to-face visits<br>|
| Experimental: mySugr app<br>Telemedical assistance with mySugr app | Device: mySugr app<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Empowerment | Change from baseline score in the Diabetes Empowerment Scale-Short Form Spanish version (DES-SF-S) (8, worse to 40, better) at 12 months | Baseline visit and month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to glycemic monitoring | Change from baseline frequency of glycemic monitoring (number of capillary blood glucose tests per day) at each follow-up visit | Baseline visit and month 3, 6, 9 and 12 | 
| Adherence to recommendations | Percentage of recommendations given by the medical team followed | Each follow-up visit (month 3, 6, 9 and 12) | 
| Adherence to visits | Percentage of face-to-face visits and telematic visits attended | Each follow-up visit (month 3, 6, 9 and 12) | 
| Adherence to the app | Percentage of patients who continue using the app after the end of the study | End of the study (month 12) and 3 months after | 
| Daily management of diabetes | Change from baseline score in the questionnaire that evaluates the number of tasks performed in relation to diabetes (ad hoc) at 12 months | Baseline visit and month 12 | 
| Quality of life related to diabetes | Change from baseline score in the Spanish version of the Diabetes Quality Of Life questionnaire (EsDQOL) (satisfaction: 75, worse, to 15, better; impact: 85, worse, to 17, better; social and vocational concern: 45, worse, to 7, better; concern related to diabetes: 20, worse, to 4, better) at 12 months | Baseline visit and month 12 | 
| Self-efficacy | Change from baseline score in the Diabetes Distress Scale Spanish version (DSS-S) (102, worse, to 17, better) at 12 months | Baseline visit and month 12 | 
| Glycemic control | Change from baseline mean blood glucose (mg/dl), standard deviation, low and high blood glucose index at each follow-up visit | Baseline visit and month 3, 6, 9 and 12 | 
| Glycemic control | Change from baseline HbA1c DCA (%) at 6 and 12 months | Baseline visit and month 6 and 12 | 
| Satisfaction with the app | Score in the satisfaction questionnaire in relation to the use of the platform (ad hoc) | End of the study (month 12) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 1, Mobile Applications, Telemedicine