Diabetes Mellitus, Type 1NCT03819335
¿Can mySugr App Improve Knowledge and Self-management of People With Type 1 Diabetes Mellitus?
A study testing mySugr app in people with Diabetes Mellitus, Type 1, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- mySugr app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSpain
- Study dates
- 9 Apr 2019to 13 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read more
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
- Being tested
- mySugr app, Standard care
- Keywords
- Diabetes Mellitus, Type 1, Mobile Applications, Telemedicine
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mySugr appDevice
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 careOther
Face-to-face visits
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Usual follow-up of diabetes type 1 with face-to-face visits Receives: Other: Standard care |
| mySugr app | Experimental | Telemedical assistance with mySugr app Receives: Device: mySugr app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline visit and month 12
Secondary outcomes (10)
Adherence to glycemic monitoring
Change from baseline frequency of glycemic monitoring (number of capillary blood glucose tests per day) at each follow-up visit
Measured: Baseline visit and month 3, 6, 9 and 12
Adherence to recommendations
Percentage of recommendations given by the medical team followed
Measured: Each follow-up visit (month 3, 6, 9 and 12)
Adherence to visits
Percentage of face-to-face visits and telematic visits attended
Measured: Each follow-up visit (month 3, 6, 9 and 12)
Adherence to the app
Percentage of patients who continue using the app after the end of the study
Measured: End of the study (month 12) and 3 months after
Daily management of diabetes
Change from baseline score in the questionnaire that evaluates the number of tasks performed in relation to diabetes (ad hoc) at 12 months
Measured: Baseline visit and month 12
Quality of life related to diabetes
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
Measured: Baseline visit and month 12
Self-efficacy
Change from baseline score in the Diabetes Distress Scale Spanish version (DSS-S) (102, worse, to 17, better) at 12 months
Measured: Baseline visit and month 12
Glycemic control
Change from baseline mean blood glucose (mg/dl), standard deviation, low and high blood glucose index at each follow-up visit
Measured: Baseline visit and month 3, 6, 9 and 12
Glycemic control
Change from baseline HbA1c DCA (%) at 6 and 12 months
Measured: Baseline visit and month 6 and 12
Satisfaction with the app
Score in the satisfaction questionnaire in relation to the use of the platform (ad hoc)
Measured: End of the study (month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start9 Apr 2019
- Primary completion26 Feb 2021
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819335
- Sponsor's protocol ID
- IIBSP-SUG-2018-01
- Status last verified
- Sep 2021
- First submitted
- 22 Jan 2019
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39412732
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03819335
- Acronym / sponsor ID
- IIBSP-SUG-2018-01
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, Mobile Applications, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 26 Feb 2021 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 28 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Other: Standard careUsual follow-up of diabetes type 1 with face-to-face visits |
| mySugr app | Experimental | Device: mySugr appTelemedical assistance with mySugr app |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mySugr appmySugr 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. | Device | mySugr app |
| Standard careFace-to-face visits | Other | Standard care |
Primary outcome
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
10 secondary outcomes
Adherence to glycemic monitoring
Time frame: Baseline visit and month 3, 6, 9 and 12
Adherence to recommendations
Time frame: Each follow-up visit (month 3, 6, 9 and 12)
Adherence to visits
Time frame: Each follow-up visit (month 3, 6, 9 and 12)
Adherence to the app
Time frame: End of the study (month 12) and 3 months after
Daily management of diabetes
Time frame: Baseline visit and month 12
Quality of life related to diabetes
Time frame: Baseline visit and month 12
Self-efficacy
Time frame: Baseline visit and month 12
Glycemic control
Time frame: Baseline visit and month 3, 6, 9 and 12
Glycemic control
Time frame: Baseline visit and month 6 and 12
Satisfaction with the app
Time frame: End of the study (month 12)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Derived from this study: PubMed 39412732Cuixart 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mySugr app in people with Diabetes Mellitus, Type 1, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Empowerment (time frame: Baseline visit and month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03819335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.