An interventional study of mySugr app and Standard care in Diabetes Mellitus, Type 1, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-21.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Not applicable, Interventional, and Supportive care
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 28 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 335 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Usual follow-up of diabetes type 1 with face-to-face visits
Other: Standard care
Telemedical assistance with mySugr app
Device: 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.
Face-to-face visits
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
Time frame: Baseline visit and month 12
Adherence to glycemic monitoring
Change from baseline frequency of glycemic monitoring (number of capillary blood glucose tests per day) at each follow-up visit
Time frame: Baseline visit and month 3, 6, 9 and 12
Adherence to recommendations
Percentage of recommendations given by the medical team followed
Time frame: Each follow-up visit (month 3, 6, 9 and 12)
Adherence to visits
Percentage of face-to-face visits and telematic visits attended
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline visit and month 3, 6, 9 and 12
Glycemic control
Change from baseline HbA1c DCA (%) at 6 and 12 months
Time frame: 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)
Time frame: End of the study (month 12)
Plan to share: No
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau