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Completed

NCT Number: NCT03819335

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

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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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard care

Other

Face-to-face visits

Primary outcomes

  1. Empowerment

    Time frame: 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 outcomes

  1. Adherence to glycemic monitoring

    Time frame: 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

  2. Adherence to recommendations

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

    Percentage of recommendations given by the medical team followed

  3. Adherence to visits

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

    Percentage of face-to-face visits and telematic visits attended

  4. Adherence to the app

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

    Percentage of patients who continue using the app after the end of the study

  5. Daily management of diabetes

    Time frame: 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

  6. Quality of life related to diabetes

    Time frame: 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

  7. Self-efficacy

    Time frame: 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

  8. Glycemic control

    Time frame: 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

  9. Glycemic control

    Time frame: Baseline visit and month 6 and 12

    Change from baseline HbA1c DCA (%) at 6 and 12 months

  10. Satisfaction with the app

    Time frame: End of the study (month 12)

    Score in the satisfaction questionnaire in relation to the use of the platform (ad hoc)

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Collaborators

  • Roche Diagnostics GmbH

Registry information

Official study title

¿Puede Una aplicación móvil Mejorar el Conocimiento y la autogestión de Las Personas Con Diabetes Tipo 1? Evaluación clínica de la App mySugr

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2019
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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