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

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ClinicalTrials.gov Identifier: NCT03455816
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Soledad Ruiz de Adana, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Social Diabetes App Device: Usual clinical monitoring group (Control group) Not Applicable

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 6 months.

The current clinical research project considers the effectiveness of a free diabetes app with a CE mark, "Social Diabetes", which incorporates the addition of a glucometer ("Glucomen Areo") it allows using NFC (Near Field Communication) technology the automatic introduction of data, evaluating the impact on metabolic results and other related psychosocial variables, in people with diabetes 1.

The substitution of the usual face-to-face medical visit every 3-4 months by the incorporation of an app system has a similar effect in terms of glycemic control (measured through HbA1c) in patients with DM1 treated with multiple doses of insulin per day (MDI). ) and inadequate metabolic control (HbA1c> 7%). In addition, it could save costs and consumption of health resources, and improve both the quality of life and the satisfaction of people with DM1.

The present study will be carried out under the usual conditions of clinical practice.

No pharmacological intervention, other than the usual clinical practice, will be applied to the included patients.

The people with diabetes 1 included in the study have a profile of "expert patient" having completed their diabetological education program at basic and advanced level (count of rations, calculations of ratios and sensitivity indexes) in such a way that the application will only be an aid in your daily decision making (mathematical calculations of ratios, IS, and recommended insulin doses, which you usually have to do "by hand").


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Clinical Study to Evaluate the Bio-Psychosocial Impact of a Mobile App for Diabetes ("SOCIAL DIABETES") and a SMARTMETER® (A. MENARINI DIAGNOSTICS) in the Care of People With Diabetes Mellitus Type 1 and Its Associated Costs
Actual Study Start Date : July 7, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Group that uses the Social Diabetes App (research group)
This group use the App Social diabetes with the glucometer Glucomen Areo to monitoring the glucemia during 6 month
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

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
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




Primary Outcome Measures :
  1. glycosylated hemoglobin [ Time Frame: 6 month ]
    Metabolic impact measured through HbA1c of a mobile application (Social Diabetes) in the care of people with DM1.

  2. Quality of life assessment: Diabetes Quality of Life (DQoL) questionnaire. [ Time Frame: 6 month ]
    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.


Secondary Outcome Measures :
  1. Mean blood glucose [ Time Frame: 6 month ]
    Glycemic control: Mean blood glucose measured in mg / dl

  2. Standard deviation [ Time Frame: 6 month ]
    Glycemic variability: Standard deviation ( SD)

  3. Number of mild hypoglycaemia [ Time Frame: 6 month ]
    Number of mild hypoglycemia in two weeks

  4. Number of severe hypoglycaemia [ Time Frame: 6 month ]
    Number of severe hypoglycaemia in the last 6 months

  5. Number of hyperglycemia [ Time Frame: 6 month ]
    Number of hyperglycemia greater than 250mg / dl in two weeks

  6. Episodes of ketosis [ Time Frame: 6 month ]
    Number of episodes of ketosis in the last 6 months

  7. Episodes of ketoacidosis [ Time Frame: 6 month ]
    Number of episodes of ketoacidosis in the last 6 months

  8. Number of hospital admissions for glycemic decompensation [ Time Frame: 6 month ]
    Number of hospital admissions for glycemic decompensation in the last 6 months.

  9. Fear of hypoglycemia: Questionnaire FH-15 [ Time Frame: 6 month ]
    Fear of hypoglycemia: measured with the FH-15 scale. 15 items related to the fear of hypoglycemia in patients with type 1 diabetes.

  10. Diabetes treatment satisfaction questionnaire ( DTSQ) [ Time Frame: 6 month ]
    8 items concerning the satisfaction of the treatment

  11. Diabetes distress scale. DDS [ Time Frame: 6 month ]
    17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col,2005)

  12. Scale of adherence to treatment in patients with diabetes type 1 [ Time Frame: 6 month ]
    15 items related to adherence to patient treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455816


Contacts
Contact: Maria Soledad Ruiz de Adana, MD PhD +34 629221089 solruizdeadana@gmail.com

Locations
Spain
Regional University Hospital of Málaga Recruiting
Málaga, Spain
Contact: Maria Soledad Ruiz de Adana, MD PhD    +34 629221089    solruizdeadana@gmail.com   
Principal Investigator: Virginia Morillas Jiménez, MD PhD         
Sponsors and Collaborators
Soledad Ruiz de Adana

Additional Information:
Publications:
Vahatalo M. Cellular phone transferred self blood glucose monitoring: Prerequisites for positive outcome. Practical Diabetes International 2004;21(5):192-194.

Responsible Party: Soledad Ruiz de Adana, Maria Soledad Ruiz de Adana, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
ClinicalTrials.gov Identifier: NCT03455816     History of Changes
Other Study ID Numbers: Social Diabetes
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Soledad Ruiz de Adana, Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud:
mobile app

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases