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

March 11, 2018 updated by: Soledad Ruiz de Adana

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Málaga, Spain
        • Recruiting
        • Regional University Hospital of Malaga
        • Contact:
        • Principal Investigator:
          • Virginia Morillas Jiménez, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
glycosylated hemoglobin
Time Frame: 6 month
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.
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.
6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean blood glucose
Time Frame: 6 month
Glycemic control: Mean blood glucose measured in mg / dl
6 month
Standard deviation
Time Frame: 6 month
Glycemic variability: Standard deviation ( SD)
6 month
Number of mild hypoglycaemia
Time Frame: 6 month
Number of mild hypoglycemia in two weeks
6 month
Number of severe hypoglycaemia
Time Frame: 6 month
Number of severe hypoglycaemia in the last 6 months
6 month
Number of hyperglycemia
Time Frame: 6 month
Number of hyperglycemia greater than 250mg / dl in two weeks
6 month
Episodes of ketosis
Time Frame: 6 month
Number of episodes of ketosis in the last 6 months
6 month
Episodes of ketoacidosis
Time Frame: 6 month
Number of episodes of ketoacidosis in the last 6 months
6 month
Number of hospital admissions for glycemic decompensation
Time Frame: 6 month
Number of hospital admissions for glycemic decompensation in the last 6 months.
6 month
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.
6 month
Diabetes treatment satisfaction questionnaire ( DTSQ)
Time Frame: 6 month
8 items concerning the satisfaction of the treatment
6 month
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)
6 month
Scale of adherence to treatment in patients with diabetes type 1
Time Frame: 6 month
15 items related to adherence to patient treatment
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soledad Ruiz de Adana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2017

Primary Completion (Anticipated)

June 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 7, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 11, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Social Diabetes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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