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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
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
Regional University Hospital of Málaga
Málaga, Spain
RECRUITINGglycosylated hemoglobin
Metabolic impact measured through HbA1c of a mobile application (Social Diabetes) in the care of people with DM1.
Time frame: 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.
Time frame: 6 month
Mean blood glucose
Glycemic control: Mean blood glucose measured in mg / dl
Time frame: 6 month
Standard deviation
Glycemic variability: Standard deviation ( SD)
Time frame: 6 month
Number of mild hypoglycaemia
Number of mild hypoglycemia in two weeks
Time frame: 6 month
Number of severe hypoglycaemia
Number of severe hypoglycaemia in the last 6 months
Time frame: 6 month
Number of hyperglycemia
Number of hyperglycemia greater than 250mg / dl in two weeks
Time frame: 6 month
Episodes of ketosis
Number of episodes of ketosis in the last 6 months
Time frame: 6 month
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Masking
NONE
Enrollment
148
Episodes of ketoacidosis
Number of episodes of ketoacidosis in the last 6 months
Time frame: 6 month
Number of hospital admissions for glycemic decompensation
Number of hospital admissions for glycemic decompensation in the last 6 months.
Time frame: 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.
Time frame: 6 month
Diabetes treatment satisfaction questionnaire ( DTSQ)
8 items concerning the satisfaction of the treatment
Time frame: 6 month
Diabetes distress scale. DDS
17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col,2005)
Time frame: 6 month
Scale of adherence to treatment in patients with diabetes type 1
15 items related to adherence to patient treatment
Time frame: 6 month