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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: Standard care; Device: mySugr app

• Registration Number: NCT03819335
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-25
• Study First Posted: 2019-01-28
• Study Start: 2019-04-09
• Primary Completion: 2021-02-26
• Study Completion: 2021-04-13
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-18
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard care	Usual follow-up of diabetes type 1 with face-to-face visits
mySugr app	mySugr app	Telemedical assistance with mySugr app

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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 6 and 12	Change from baseline HbA1c DCA (%) at 6 and 12 months
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)
Adherence to recommendations	Each follow-up visit (month 3, 6, 9 and 12)	Percentage of recommendations given by the medical team followed
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

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain