Status:
UNKNOWN
Clinical Study to Evaluate the Bio-Psychosocial Impact of Mobile App for Diabetes Type 1 ("SOCIAL DIABETES")
Lead Sponsor:
Soledad Ruiz de Adana
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Based on international recommendations, the current clinical research project considers the effectiveness of a free diabetes app with a CE (Conformité Européenne) mark, "Social Diabetes", which incorp...
Detailed Description
Randomized study in people with type 1 diabetes in intensive insulin therapy MDI with analogues and with HbA1c\> 7% to the usual clinical follow-up options (CG) vs use of Social Diabetes App (GI) for ...
Eligibility Criteria
Inclusion
- Patients with DM1 over 1 year evolution.
- Age ≥18 and \<65 years.
- HbA1c prior to the inclusion of the study\> 7%.
- Intensive insulin treatment with MDI in basal-bolus regimen.
- Patients with basic digital skills and with 3G mobile phone and NFC technology.
- Patients who have given their informed consent in writing.
Exclusion
- Treatment with subcutaneous insulin infusor (ISCI)
- Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
- Pregnancy or pregnancy planning.
- Diabetes mellitus type 2.
- Severe psychological alterations.
- Absence of collaboration (informed consent).
- Patients who are participating in other clinical studies.
Key Trial Info
Start Date :
July 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT03455816
Start Date
July 7 2017
End Date
December 1 2018
Last Update
March 13 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Regional University Hospital of Málaga
Málaga, Spain