Clinical trial NCT03455816: Clinical Study to Evaluate the Bio-Psychosocial Impact of Mobile App for Diabetes Type 1 ("SOCIAL DIABETES")
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: mobile app
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2018-03-07
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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").

Eligibility 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.

Primary outcomes:
measure: glycosylated hemoglobin
timeFrame: 6 month
measure: Quality of life assessment: Diabetes Quality of Life (DQoL) questionnaire.
timeFrame: 6 month
Secondary outcomes:
measure: Mean blood glucose
timeFrame: 6 month
measure: Standard deviation
timeFrame: 6 month
measure: Number of mild hypoglycaemia
timeFrame: 6 month
measure: Number of severe hypoglycaemia
timeFrame: 6 month
measure: Number of hyperglycemia
timeFrame: 6 month
measure: Episodes of ketosis
timeFrame: 6 month
measure: Episodes of ketoacidosis
timeFrame: 6 month
measure: Number of hospital admissions for glycemic decompensation
timeFrame: 6 month
measure: Fear of hypoglycemia: Questionnaire FH-15
timeFrame: 6 month
measure: Diabetes treatment satisfaction questionnaire ( DTSQ)
timeFrame: 6 month
measure: Diabetes distress scale. DDS
timeFrame: 6 month
measure: Scale of adherence to treatment in patients with diabetes type 1
timeFrame: 6 month
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Regional University Hospital of Málaga
Study officials:
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