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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03819335
• Other study ID #: IIBSP-SUG-2018-01
• Status: Completed
• Phase: N/A
• Start date: April 9, 2019
• Est. completion date: April 13, 2021

Study information

• Verified date: September 2021
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: April 13, 2021
• Est. primary completion date: February 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.

Other:
• Standard care
Face-to-face visits

Locations

Country	Name	City	State
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Roche Diagnostics

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Adherence to recommendations	Percentage of recommendations given by the medical team followed	Each follow-up visit (month 3, 6, 9 and 12)
Secondary	Adherence to visits	Percentage of face-to-face visits and telematic visits attended	Each follow-up visit (month 3, 6, 9 and 12)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Glycemic control	Change from baseline HbA1c DCA (%) at 6 and 12 months	Baseline visit and month 6 and 12
Secondary	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)