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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

Tracking Information
First Submitted Date  ICMJE January 22, 2019
First Posted Date  ICMJE January 28, 2019
Last Update Posted Date April 11, 2019
Actual Study Start Date  ICMJE April 9, 2019
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03819335 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 25, 2019)
  • 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
  • Adherence to recommendations [ Time Frame: Each follow-up visit (month 3, 6, 9 and 12) ]
    Percentage of recommendations given by the medical team followed
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Glycemic control [ Time Frame: Baseline visit and month 6 and 12 ]
    Change from baseline HbA1c DCA (%) at 6 and 12 months
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ¿Can a Mobile App Improve Knowledge and Self-management of People With Type 1 Diabetes Mellitus? Clinical Evaluation of mySugr App
Official Title  ICMJE ¿Puede Una aplicación móvil Mejorar el Conocimiento y la autogestión de Las Personas Con Diabetes Tipo 1? Evaluación clínica de la App mySugr
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Standard care
    Usual follow-up of diabetes type 1 with face-to-face visits
    Intervention: Other: Standard care
  • Experimental: mySugr app
    Telemedical assistance with mySugr app
    Intervention: Device: mySugr app
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 25, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Cintia González Blanco, MD, PhD +34610898918 cgonzalezb@santpau.cat
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03819335
Other Study ID Numbers  ICMJE IIBSP-SUG-2018-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Sponsor  ICMJE Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborators  ICMJE Roche Diagnostics
Investigators  ICMJE Not Provided
PRS Account Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP