A Telematic Program for Optimization of Metabolic Control in Diabetes Mellitus Type 1 (DM1) Patients
Condition: Diabetes Mellitus, Type 1; Metabolic Disorder
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Metabolic Diseases
Study type: Interventional

Summary: 
      A greater visit frequency between the diabetes mellitus 1 (DM1) patient and the medical team
      increases the possibilities to improve metabolic control. The support of telematic visits can
      support the patient and the health system.

      Patients and Method: 160 patients (from 5 participating centres) with type 1 diabetes
      mellitus (DM1) candidates for improved metabolic control selected according to inclusion and
      exclusion criteria. The telecare system used is comprised of the patient Unit and the doctor
      Unit. The system allows the patient to send glucose values, insulin doses, carbohydrate
      contribution and other events via the internet. Both the patient and the professional can use
      this information via the telecare system platform.

      Work hypothesis

      The application of interactive telematic systems between patient-health team will improve the
      cost effectiveness of care programmes for optimisation of metabolic control directed towards
      diabetes mellitus (DM1) patients.

      Objectives:

      General Objective Evaluate the impact of the telecare system on the efficiency of economic
      and clinical management of human and material resources directed to a program of metabolic
      control optimisation in diabetes mellitus 1 (DM1) patients as well as the level of metabolic
      control and the quality of life of the patients.

      Specific objectives

        1. To identify and analyse the influence of the telecare system on patient costs in time,
           money and normal work or school activity which the patient has to stop to carry out the
           physical visits for following the programme.

        2. To identify and analyse the influence of the telecare system on medical team costs in
           time, money and care organisation directed towards the monitoring phase of the metabolic
           control care programme.

        3. To identify and analyse the influence of the telecare system on the level of metabolic
           control: Glycosylated haemoglobin and the presence of acute hypoglycemic and
           hyperglycaemic complications in diabetes mellitus 1 (DM1) patients that follow the
           metabolic optimisation programme.

        4. To identify and analyse the influence of the telecare system on the quality of life of
           the patient measured in satisfaction scale, impact, social/work concern and concern
           relating to diabetes.

        5. To identify and analyse the influence of the telecare system on the adherence to
           different treatment components.
    

Detailed description: 
      *Title: Multicentric random, prospective, open and comparative intervention study evaluating
      the efficiency of the implementation in the Spanish Health System of a telematic system
      applied to metabolic control optimization for type 1 diabetes mellitus (DM1) patients.

        -  Protocol:

           1) Pre-intervention. After the patient is informed and accepts the protocol they make 2
           visits for planning individual treatment. 2) Random Assignment in 2 Groups: A)
           Intervention (telecare system). B) Control. The intervention group patients will be
           trained in the telecare system machine. Both groups will make the same number of 6
           visits over 6 months: Intervention Group (5 telematics and 1 hospital), Control group (6
           hospital). Results will be assessed at 3 and 6 months and reassessed at 12 months.

        -  Patients The objective of the present study is to demonstrate that telematic control of
           diabetes mellitus is not inferior to the face to face visit control system, while
           showing an added value an important reduction in costs. Cost information from three
           studies have been used for the calculation of the sample 2,3,20 in diabetes mellitus 1
           (DM1) patients, some followed in a telematic form (210 ± 184€) and other in the form of
           face to face visits (376 ± 278€). Relating to this, 72 patients per group are needed to
           obtain a statistical power of 99% and an alpha level of 0.05 (two-sided). 80 patients
           per group will be needed to be randomised taking into account a 10% loss percentage.

      Participating Centres

        -  Hospital Clínico. Barcelona

        -  Hospital Clínico. Valencia

        -  Hospital Carlos Haya. Málaga

        -  Hospital Clínico. Madrid

        -  Hospital de Cruces. Barakaldo

      Each arm will include 80 patients, 160 as a total.
    

Intervention name(s): Control; Telecare system
Intervention type(s): Other; Device
Intervention description(s): 7 face-to-face visits.; 5 telematic visits and 2 face-to-face visits.
Other intervention name(s): Control group do not use telematic system.; Medical Guard Diabetes®; - Access in internet: https://www.medicalguard.net/; - Pulso Ediciones SL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telemedicine; Type 1 diabetes; Metabolic control optimisation; Health care costs; Intervention study; Access to internet