Clinical Study to Evaluate the Bio-Psychosocial Impact of Mobile App for Diabetes Type 1 ("SOCIAL DIABETES")
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03455816|
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : March 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Device: Social Diabetes App Device: Usual clinical monitoring group (Control group)||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||148 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 7, 2017|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Group that uses the Social Diabetes App (research group)
This group use the App Social diabetes with the glucometer Glucomen Areo to monitoring the glucemia during 6 month
Device: Social Diabetes App
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
Device: Usual clinical monitoring group (Control group)
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
- glycosylated hemoglobin [ Time Frame: 6 month ]Metabolic impact measured through HbA1c of a mobile application (Social Diabetes) in the care of people with DM1.
- Quality of life assessment: Diabetes Quality of Life (DQoL) questionnaire. [ Time Frame: 6 month ]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.
- Mean blood glucose [ Time Frame: 6 month ]Glycemic control: Mean blood glucose measured in mg / dl
- Standard deviation [ Time Frame: 6 month ]Glycemic variability: Standard deviation ( SD)
- Number of mild hypoglycaemia [ Time Frame: 6 month ]Number of mild hypoglycemia in two weeks
- Number of severe hypoglycaemia [ Time Frame: 6 month ]Number of severe hypoglycaemia in the last 6 months
- Number of hyperglycemia [ Time Frame: 6 month ]Number of hyperglycemia greater than 250mg / dl in two weeks
- Episodes of ketosis [ Time Frame: 6 month ]Number of episodes of ketosis in the last 6 months
- Episodes of ketoacidosis [ Time Frame: 6 month ]Number of episodes of ketoacidosis in the last 6 months
- Number of hospital admissions for glycemic decompensation [ Time Frame: 6 month ]Number of hospital admissions for glycemic decompensation in the last 6 months.
- Fear of hypoglycemia: Questionnaire FH-15 [ Time Frame: 6 month ]Fear of hypoglycemia: measured with the FH-15 scale. 15 items related to the fear of hypoglycemia in patients with type 1 diabetes.
- Diabetes treatment satisfaction questionnaire ( DTSQ) [ Time Frame: 6 month ]8 items concerning the satisfaction of the treatment
- Diabetes distress scale. DDS [ Time Frame: 6 month ]17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col,2005)
- Scale of adherence to treatment in patients with diabetes type 1 [ Time Frame: 6 month ]15 items related to adherence to patient treatment
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455816
|Contact: Maria Soledad Ruiz de Adana, MD PhD||+34 email@example.com|
|Regional University Hospital of Málaga||Recruiting|
|Contact: Maria Soledad Ruiz de Adana, MD PhD +34 629221089 firstname.lastname@example.org|
|Principal Investigator: Virginia Morillas Jiménez, MD PhD|