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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Social Diabetes App
* Device: Usual clinical monitoring group (Control group)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention 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)<br>This group use the App Social diabetes with the glucometer Glucomen Areo to monitoring the glucemia during 6 month | Device: Social Diabetes App<br>* 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<br>|
| Active Comparator: Usual clinical monitoring group (control group)<br>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)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean blood glucose | Glycemic control: Mean blood glucose measured in mg / dl | 6 month | 
| Standard deviation | Glycemic variability: Standard deviation ( SD) | 6 month | 
| Number of mild hypoglycaemia | Number of mild hypoglycemia in two weeks | 6 month | 
| Number of severe hypoglycaemia | Number of severe hypoglycaemia in the last 6 months | 6 month | 
| Number of hyperglycemia | Number of hyperglycemia greater than 250mg / dl in two weeks | 6 month | 
| Episodes of ketosis | Number of episodes of ketosis in the last 6 months | 6 month | 
| Episodes of ketoacidosis | Number of episodes of ketoacidosis in the last 6 months | 6 month | 
| Number of hospital admissions for glycemic decompensation | Number of hospital admissions for glycemic decompensation in the last 6 months. | 6 month | 
| Fear of hypoglycemia: Questionnaire FH-15 | 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) | 8 items concerning the satisfaction of the treatment | 6 month | 
| Diabetes distress scale. DDS | 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 | 15 items related to adherence to patient treatment | 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mobile app