Telemedicine Program in Type 1 Diabetes and CSII
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Diabetes mellitus is a chronic disease of high socio-health relevance for their clinical and
      economic implications (risk of complications, disability ...) (healthcare costs). Strict
      glycemic control and intensive treatment and support have shown long-term patient with type 1
      diabetes mellitus (DM1) improved health. The intensive insulin therapy involves the
      administration of insulin through 3 or more injections per day (MDI), or through a continuous
      subcutaneous insulin infusion (CSII). New technologies applied to the treatment of DM1, such
      as telemedicine, could bring benefits to patients. The available scientific evidence to date
      shows that telemedicine systems have beneficial or neutral effects on glycemic control,
      expressed in terms of HbA1c in patients with type 1 diabetes treated with MDI or CSII. They
      have also shown not to worsen the quality of life and reduce the costs associated with the
      care of these subjects. However, studies published to date are generally short follow-up,
      small sample size, and have not evaluated other biological parameters such as glycemic
      variability, inflammatory markers and markers of oxidative stress as well as a psychological
      assessment including depression, anxiety, Diabetes-related distress and fear of hypoglycemia.
      It has been designed a randomized crossover 18 months in order to study the effect of a
      telemedicine program in a group of subjects with DM1 in CSII on clinical variables of
      metabolic control variables, including parameters of glycemic variability, markers of
      inflammation and oxidative stress, psychological variables and quality of life, and
      associated costs.
    

Detailed description: 
      Randomized crossover clinical trial about the impact of a telemedicine program (Emminens
      Conecta® System, Roche Diagnostics SL) vs. the conventional medical follow-face of 18 months
      for the care of patients with DM1 intensive treatment with CSII (Accu-Chek Spirit®, Roche
      SL).

      Two groups: one group with interactive clinical monitoring through a telemedicine platform
      (TM) and other conventional medical follow-up group (SMC) during 6 months. Being a crossover
      trial, both groups passing through both conditions (TM and SMC) during 6 months.
    

Intervention name(s): Group 2a. Telemedicine program; Group 1a. Control; Group 1b.Telemedicine program; Group 2b. Control
Intervention type(s): Other; Other; Other; Other
Intervention description(s): CSII (Accu-Chek Spirit®) and medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months).; Treatment with CSII (Accu-Chek Spirit®) and follow-face doctor visits (conventional treatment -SMC-) (6 months).; After a washout period of 3 months and the crossing, Group 1 begins with medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months).; After a washout period of 3 months and the crossing, Group 2 begins with face doctor visits (conventional treatment -SMC-) (6 months) .
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes; Health technologies; Continuous subcutaneous insulin infusion; Telemedicine; Glycemic variability; Inflammatory markers,; Oxidative stress; Depression; Quality of life; Cost-effectiveness