Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes Mellitus, Type 1, Mobile Applications, Telemedicine
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.
Interventions
DEVICEmySugr 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.
OTHERStandard care
Face-to-face visits
Sponsors
Roche Diagnostics GmbH
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Empowerment | Baseline visit and month 12 | Change from baseline score in the Diabetes Empowerment Scale-Short Form Spanish version (DES-SF-S) (8, worse to 40, better) at 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to recommendations | Each follow-up visit (month 3, 6, 9 and 12) | Percentage of recommendations given by the medical team followed |
| Adherence to visits | Each follow-up visit (month 3, 6, 9 and 12) | Percentage of face-to-face visits and telematic visits attended |
| Adherence to the app | End of the study (month 12) and 3 months after | Percentage of patients who continue using the app after the end of the study |
| Daily management of diabetes | Baseline visit and month 12 | Change from baseline score in the questionnaire that evaluates the number of tasks performed in relation to diabetes (ad hoc) at 12 months |
| Adherence to glycemic monitoring | Baseline visit and month 3, 6, 9 and 12 | Change from baseline frequency of glycemic monitoring (number of capillary blood glucose tests per day) at each follow-up visit |
| Self-efficacy | Baseline visit and month 12 | Change from baseline score in the Diabetes Distress Scale Spanish version (DSS-S) (102, worse, to 17, better) at 12 months |
| Glycemic control | Baseline visit and month 3, 6, 9 and 12 | Change from baseline mean blood glucose (mg/dl), standard deviation, low and high blood glucose index at each follow-up visit |
| Satisfaction with the app | End of the study (month 12) | Score in the satisfaction questionnaire in relation to the use of the platform (ad hoc) |
| Quality of life related to diabetes | Baseline visit and month 12 | 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 |
Countries
Spain
Outcome results
None listed