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Clinical Study to Evaluate the Bio-Psychosocial Impact of Mobile App for Diabetes Type 1 ("SOCIAL DIABETES")

NCT03455816 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2018-03-13

No results posted yet for this study

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 incorporates the addition of a glucometer ("Glucomen Areo") it allows using NFC technology the automatic introduction of data, evaluating the impact on metabolic results and other related psychosocial variables, in people with diabetes 1 through a randomized randomized study during 6 months of follow-up.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Social Diabetes App

Social diabetes is an app for diabetes, free with CE mark, that by means of the incorporation of a glucometer ("glucomen Areo") allows through NFC technology the automatic introduction of data in the application

DEVICE

Usual clinical monitoring group (Control group)

Active Comparator: Usual clinical monitoring group (control group) This group does not use the App. This group have an intermediate visit at 3 months with de doctor to see blood glucose self-monitoring and propose adjustments

Sponsors & Collaborators

  • Soledad Ruiz de Adana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2018-06-30
Completion
2018-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03455816 on ClinicalTrials.gov