Intelligent and Educational System for Gestational Diabetes Management
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational
Study type: Interventional

Summary: 
      Gestational diabetes, diabetes diagnosed during pregnancy, affects 8.8% of pregnancies in
      Spain that means more than 40,000 women per year. This prevalence is based on the National
      Diabetes Data Group criteria, previous to the 4th workshop on Gestational Diabetes (1998),
      but, if the new diagnosis criteria proposed by the International Associations of Diabetes and
      Pregnancy Study Groups, based on the most important study never made before on this topic,
      prevalence would increase to the double. When a women is diagnosed, the risk of complications
      for her and the child increases and, therefore, she has to start an specific diet and
      frequent visits to the diabetes center in order to check that glucose values do not exceed 95
      mg/dl before or 140 mg/dl 1-hour after meals. In other case, she should start insulin
      treatment. Our project is aimed to develop intelligent tools based on neuro-diffuse
      techniques and integrated in a telemedicine system that allows control of gestational
      diabetes automatically, guaranteeing glucose control objectives consecution and avoiding
      face-to-face visits to the health care center. Furthermore, educational and motivation tools
      for a healthy behaviour will be included. At the end of the study efficacy and security about
      insulin management will be compare with the recommendations proposed by the diabetes team and
      data about direct and indirect costs will be calculated. The investigators anticipate that
      the smart telemedicine system can allow us to detect high blood glucose values earlier than
      in-person scheduled visits.
    

Detailed description: 
      This study aims to evaluate the safety and usability of a telemedicine system which includes
      intelligent tools for blood glucose analysis and supporting routine clinical monitoring
      carried out by nurses and endocrinologists.

      Type of study: Prospective, controlled, randomized (2:1) Participants: pregnant women
      diagnosed with gestational diabetes according to the National Diabetes Data Group criteria
      between 14 and 34 weeks of gestation. Patients with suspected clinical diagnosis of type 1 or
      type 2 diabetes will be excluded.

      In addition to the signed acceptance to participate in the study, requirements are:

        -  Availability of a desktop computer or laptop with an internet connection and USB port.

        -  Sufficient knowledge of Catalan and/or Spanish

        -  A mobile phone Objective: To technically evaluate the SineDie telemedicine system and
           also the users' degree of satisfaction.

      Methodology of the study: Once signed consent for participation the patient will be
      randomized either to continue regularly scheduled visits (33% chance) or to use the
      Telemedicine system (66% chance). The randomization will be done using a system of allocation
      based on random numbers. The SINEDiE system includes:

        -  Educational Program

        -  Automatical Evaluation of glucose data -immediately after each download (frequency not
           exceeding 72 hours)

        -  Alerts in case of failure of receiving information at the scheduled time or in case of
           incompleteness.

        -  Alerts for glucose values higher than desirable but which could be corrected by diet
           changes and / or exercise

        -  Alerts for high glucose values which cannot be corrected with the previous mentioned
           changes. In this case an appointment for face-to-face visit would be made.

      All warnings are also reported as an email to the endocrinologist and nurse

      Variables:

        -  Statistical analysis of data: blood glucose, standard deviation, number of preprandial
           values> 90, the number of postprandial values of> 140 messages and warnings

        -  Analytical variables: HbA1c at the start and every 4 weeks

        -  Complications of pregnancy and childbirth if any.

        -  Neonatal Complications if any

        -  Survey of satisfaction with telemedicine tool

      Expected duration of the study: 6 months Number of patients included 20 patients
    

Intervention name(s): Smart telemedicine remote monitoring for gestational diabetes; Usual management
Intervention type(s): Other; Other
Intervention description(s): Intervention consists of a telemedicine platform which includes artificial intelligence tools to analyse glucose values and guarantee an optimal glucose control from the diagnosis of gestational diabetes to delivery.; Usual care will be provided, including face-to-face visits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Gestational diabetes; Telemedicine; Artificial Intelligence