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

NCT03819335 | Completed DMC

• 1 other identifier: IIBSP-SUG-2018-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1; Mobile Applications; Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Adherence to glycemic monitoring

  Baseline visit and month 3, 6, 9 and 12

• Adherence to recommendations

  Each follow-up visit (month 3, 6, 9 and 12)

• Adherence to visits

  Each follow-up visit (month 3, 6, 9 and 12)

• Adherence to the app

  End of the study (month 12) and 3 months after

• Daily management of diabetes

  Baseline visit and month 12

Study Arms (2)

Standard care

ACTIVE COMPARATOR

Usual follow-up of diabetes type 1 with face-to-face visits

Other: Standard care

mySugr app

EXPERIMENTAL

Telemedical assistance with mySugr app

Device: mySugr app

Interventions

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.

mySugr app

Standard care OTHER

Face-to-face visits

Standard care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Roche Diagnostics GmbH: collaborator

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (1)

• 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.

  PMID: 39412732 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: January 28, 2019
• Study Start: April 9, 2019
• Primary Completion: February 26, 2021
• Study Completion: April 13, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)