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| Name | Class |
|---|---|
| Roche Diagnostics GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | Active Comparator | Usual follow-up of diabetes type 1 with face-to-face visits |
|
| mySugr app | Experimental | Telemedical assistance with mySugr app |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mySugr app | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39412732 | Derived | Cuixart G, Corcoy R, Gonzalez C. Can a mobile application improve glucose-related and patient-reported outcome measures (PROMs) in people with type 1 diabetes mellitus? A randomized controlled trial using the mySugr(R) app. Hormones (Athens). 2025 Mar;24(1):137-147. doi: 10.1007/s42000-024-00609-z. Epub 2024 Oct 16. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard care | Other | Face-to-face visits |
|
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) |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |