Evaluation of a Mobile Application to Optimize Self-decision on Metabolic Control in Persons With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Adolescents with type 1 diabetes mellitus (T1 DM) tend to have poor metabolic control. There
      are no mobile applications in our language in our environment, and patients are accessible in
      addition to the difficulties involved in these manual calculations. One way to bridge the
      knowledge gaps in T1 DM self-management is by using technology to optimize metabolic control
      and reduce the risks of associated comorbidities, with a mobile application that helps
      optimize decision-making in self-management. This research aims to help people with type 1
      diabetes to change the glycemic blood levels and to be able to calculate the food together
      with the amount of insulin with food from the region. To evaluate the acceptability and
      effectiveness of the application, the investigators will carry out a pilot evaluation test.
      The participants in this pilot test will be 20 people between 14 and 18 years old with T1DM,
      users of the pediatric diabetology service of the National Institute of Diabetes,
      Endocrinology, and Nutrition (INDEN).
    

Detailed description: 
      Metabolic lack of control in patients with type 1 diabetes Mellitus (T1DM) leads to kidney
      failure, non-traumatic amputations, blindness, and reduced life expectancy. In addition,
      determining the content of macronutrients in food is not the domain of many patients,
      particularly adolescents, or some physicians, making insulin adjustment difficult, one of the
      main failures of optimal metabolic control. One way to bridge the knowledge gaps in T1D
      self-management is by using technology to optimize metabolic control and reduce the risks of
      associated comorbidities, with a mobile application that helps optimize decision-making in
      self-management. And a reduction of complications in adolescents (14-18 years) with T1DM.
      This project aims to develop this application that contributes to decision-making and the
      reduction of comorbidities of adolescents with T1DM, following the policies of the Dominican
      state through Digital systems, together with its educational mission, technological access,
      and national competitiveness.

      There are no mobile applications in use in the Dominican Republic for the self-management of
      chronic diseases. Therefore, the investigators have designed a mobile application with a
      postprandial insulin bolus calculator. In addition, the developers has added a list of foods
      from the region where users can select their foods and adjust them with the amount of insulin
      to metabolize them. The methodology includes a mixed approach (qualitative and quantitative)
      before starting the study and after three months of using the application.

      To evaluate the acceptability and effectiveness of the application, we will carry out a pilot
      evaluation test. The participants in this pilot test will be 20 people between 14 and 18
      years old with T1DM, users of INDEN. This experimental study has a systematized probabilistic
      sample from the center's master list. They were randomized, not controlled. Therefore, the
      participants are users of the pediatric diabetology service, and included prior explanation
      and approval of informed consent. These 20 participants will be recruited, ensuring the
      equitable distribution between gender and sociodemographic data of the mentioned group while
      maintaining the intention to treat.

      Inclusion criteria:

      -Patients between 14-18 years old with diabetes type 1.

      Exclusion criteria

        -  Patients with Glomerular filtration rate less than 60 mL/min

        -  Inability to use electronic devices.

        -  Admission due to acute decompensation of T1DM in previous 3 months, presence of more
           than one severe monthly hypoglycemia, or any other circumstance that requires frequent
           visits and intensive care.

        -  Inability to sign the informed consent.

      The investigators invited the participants to select foods and routinely use the mobile app's
      insulin bolus calculator for three months.

      For data analysis, the researchers are going to perform the normality test for numerical
      variables. Then, the categorical data presentation will be with frequencies and percentages
      tables and the quantitative data as means and standard deviation, and use a non-Gaussian
      distribution, Kruskal-Wallis and Mann-Whitney tests.

      The primary endpoint, HbA1c at the beginning of the study and the end of the third month of
      use of the application, will be analyzed with Kruskal-Wallis and Mann-Whitney tests and for
      pre-test and post-test comparisons of the study group, and the multifactorial analysis of
      variance (ANCOVA), baseline HbA1c level and at 3 months after using the application, taking
      into account age as covariates. The investigators are going to use for statistical analysis
      the Statistical Package for the Social Sciences (SPSS), and Excel of the data obtained.
    

Intervention name(s): PRE-test
Intervention type(s): Other
Intervention description(s): we are going to verify glucose levels before (pre) and after (post) the use of the mobile application.
Other intervention name(s): Post-Test
Intervention model: Single Group Assignment
Intervention model description: Evaluating pre-test and post-test (pre and post glucose levels)
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: diabetes type 1; insulin bolus calculator; macronutrients