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

Soledad Ruiz de Adana

Status: Unknown

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Social Diabetes App; Device: Usual clinical monitoring group (Control group)

Study type: Interventional

Funder types: Other

Identifiers

NCT03455816

Social Diabetes

Details and patient eligibility

About

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.

Full 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").

Enrollment: 148 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Group that uses the Social Diabetes App (research group)

Experimental group

Description:

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

Treatment:

Device: Social Diabetes App

Usual clinical monitoring group (control group)

Active Comparator group

Description:

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

Treatment:

Device: Usual clinical monitoring group (Control group)