Diabetes Mellitus, Type 1 Clinical Trial
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
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").
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