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

NCT03455816 | Unknown DMC

• 1 other identifier: Social Diabetes
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 1

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 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

Keywords

mobile app

Outcome Measures

Primary Outcomes (2)

• glycosylated hemoglobin

  Metabolic impact measured through HbA1c of a mobile application (Social Diabetes) in the care of people with DM1.

  6 month

• Quality of life assessment: Diabetes Quality of Life (DQoL) questionnaire.

  34 items to analyze the biopsychosocial impact measured through the quality of life questionnaire (DQol) of a mobile application (Social Diabetes) in the care of people with DM1.

  6 month

Secondary Outcomes (12)

• Mean blood glucose

  6 month

• Standard deviation

  6 month

• Number of mild hypoglycaemia

  6 month

• Number of severe hypoglycaemia

  6 month

• Number of hyperglycemia

  6 month

Study Arms (2)

Group that uses the Social Diabetes App (research group)

EXPERIMENTAL

This group use the App Social diabetes with the glucometer Glucomen Areo to monitoring the glucemia during 6 month

Device: Social Diabetes App

Usual clinical monitoring group (control group)

ACTIVE COMPARATOR

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

Device: Usual clinical monitoring group (Control group)

Interventions

Social Diabetes App DEVICE

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

Group that uses the Social Diabetes App (research group)

Usual clinical monitoring group (Control group) DEVICE

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

Usual clinical monitoring group (control group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with DM1 over 1 year evolution.
• Age ≥18 and \<65 years.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Soledad Ruiz de Adana: lead

Study Sites (1)

Regional University Hospital of Málaga

Málaga, Spain

RECRUITING

Related Publications (25)

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  BACKGROUND

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  PMID: 17395516 BACKGROUND

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  PMID: 22868871 BACKGROUND

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  PMID: 17586735 BACKGROUND

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  PMID: 15111526 BACKGROUND

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  PMID: 24876569 BACKGROUND

• Anarte Ortiz MT, Caballero FF, Ruiz de Adana MS, Rondan RM, Carreira M, Dominguez-Lopez M, Machado A, Gonzalo-Marin M, Tapia MJ, Valdes S, Gonzalez-Romero S, Soriguer FC. Development of a new fear of hypoglycemia scale: FH-15. Psychol Assess. 2011 Jun;23(2):398-405. doi: 10.1037/a0021927.

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Maria Soledad Ruiz de Adana, MD PhD

CONTACT

+34 629221089; solruizdeadana@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Maria Soledad Ruiz de Adana

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: March 7, 2018
• Study Start: July 7, 2017
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

ES (1)