¿Can mySugr App Improve Knowledge and Self-management of People With Type 1 Diabetes Mellitus?
September 18, 2021 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
¿Puede Una aplicación móvil Mejorar el Conocimiento y la autogestión de Las Personas Con Diabetes Tipo 1? Evaluación clínica de la App mySugr
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Barcelona, Spain, 08025
- Hospital de La Santa Creu i Sant Pau
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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ACTIVE_COMPARATOR: Standard care
Usual follow-up of diabetes type 1 with face-to-face visits
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Face-to-face visits
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EXPERIMENTAL: mySugr app
Telemedical assistance with mySugr app
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Empowerment
Time Frame: Baseline visit and month 12
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Change from baseline score in the Diabetes Empowerment Scale-Short Form Spanish version (DES-SF-S) (8, worse to 40, better) at 12 months
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Baseline visit and month 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to glycemic monitoring
Time Frame: Baseline visit and month 3, 6, 9 and 12
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Change from baseline frequency of glycemic monitoring (number of capillary blood glucose tests per day) at each follow-up visit
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Baseline visit and month 3, 6, 9 and 12
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Adherence to recommendations
Time Frame: Each follow-up visit (month 3, 6, 9 and 12)
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Percentage of recommendations given by the medical team followed
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Each follow-up visit (month 3, 6, 9 and 12)
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Adherence to visits
Time Frame: Each follow-up visit (month 3, 6, 9 and 12)
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Percentage of face-to-face visits and telematic visits attended
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Each follow-up visit (month 3, 6, 9 and 12)
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Adherence to the app
Time Frame: End of the study (month 12) and 3 months after
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Percentage of patients who continue using the app after the end of the study
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End of the study (month 12) and 3 months after
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Daily management of diabetes
Time Frame: Baseline visit and month 12
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Change from baseline score in the questionnaire that evaluates the number of tasks performed in relation to diabetes (ad hoc) at 12 months
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Baseline visit and month 12
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Quality of life related to diabetes
Time Frame: Baseline visit and month 12
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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
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Baseline visit and month 12
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Self-efficacy
Time Frame: Baseline visit and month 12
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Change from baseline score in the Diabetes Distress Scale Spanish version (DSS-S) (102, worse, to 17, better) at 12 months
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Baseline visit and month 12
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Glycemic control
Time Frame: Baseline visit and month 3, 6, 9 and 12
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Change from baseline mean blood glucose (mg/dl), standard deviation, low and high blood glucose index at each follow-up visit
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Baseline visit and month 3, 6, 9 and 12
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Glycemic control
Time Frame: Baseline visit and month 6 and 12
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Change from baseline HbA1c DCA (%) at 6 and 12 months
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Baseline visit and month 6 and 12
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Satisfaction with the app
Time Frame: End of the study (month 12)
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Score in the satisfaction questionnaire in relation to the use of the platform (ad hoc)
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End of the study (month 12)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 9, 2019
Primary Completion (ACTUAL)
February 26, 2021
Study Completion (ACTUAL)
April 13, 2021
Study Registration Dates
First Submitted
January 22, 2019
First Submitted That Met QC Criteria
January 25, 2019
First Posted (ACTUAL)
January 28, 2019
Study Record Updates
Last Update Posted (ACTUAL)
September 21, 2021
Last Update Submitted That Met QC Criteria
September 18, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIBSP-SUG-2018-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.