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

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ClinicalTrials.gov Identifier: NCT03819335
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : April 11, 2019
Sponsor:
Collaborator:
Roche Diagnostics
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: mySugr app Other: Standard care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Standard care
Usual follow-up of diabetes type 1 with face-to-face visits
Other: Standard care
Face-to-face visits

Experimental: mySugr app
Telemedical assistance with mySugr app
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03819335


Contacts
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Contact: Cintia González Blanco, MD, PhD +34610898918 cgonzalezb@santpau.cat

Locations
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Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Barcelona, Spain, 08025
Contact: Cintia Gonzalez Blanco, MD, PhD    +34610898918    cgonzalezb@santpau.cat   
Principal Investigator: Cintia Gonzalez Blanco, MD, PhD         
Sub-Investigator: Gemma Cuixart Carruesco, MD         
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Roche Diagnostics

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT03819335     History of Changes
Other Study ID Numbers: IIBSP-SUG-2018-01
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau:
Diabetes Mellitus, Type 1
Mobile Applications
Telemedicine
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases