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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
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) .
Assessment of clinical and metabolic parameters (glycosylated hemoglobin-HbA1c- and glycemic variability-SD-).
Time frame: Baseline: Group 1 and 2
Assessment of clinical and metabolic parameters (glycosylated hemoglobin-HbA1c- and glycemic variability-SD-).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of inflammatory markers (hs-CRP).
Time frame: Baseline: Group 1 and 2
Assessment of inflammatory markers (IL-6).
Time frame: Baseline: Group 1 and 2
Assessment of inflammatory markers (TNF-α).
Time frame: Baseline: Group 1 and 2
Assessment of inflammatory markers (MCP-1).
Time frame: Baseline: Group 1 and 2
Assessment of inflammatory markers (hs-CRP).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of inflammatory markers (IL-6).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of inflammatory markers (TNF-α).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of inflammatory markers (MCP-1).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of redox markers (CAT).
Time frame: Baseline: Group 1 and 2
Assessment of redox markers (TBARS).
Time frame: Baseline: Group 1 and 2
Assessment of redox markers (oxidized LDL).
Time frame: Baseline: Group 1 and 2
Assessment of redox markers (CAT).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of redox markers (TBARS).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of redox markers (oxidized LDL).
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of quality of life with the DQOL
Time frame: Baseline: Group 1 and 2
Assessment of quality of life with the DQOL
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of depression with the BDI-II
Time frame: Baseline: Group 1 and 2
Assessment of depression with the BDI-II
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of anxiety with the STAI
Time frame: Baseline: Group 1 and 2
Assessment of anxiety with the STAI
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of distress related to diabetes with the DDS
Time frame: Baseline: Group 1 and 2
Assessment of distress related to diabetes with the DDS
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of treatment satisfaction with the DTSQ
Time frame: Baseline: Group 1 and 2
Assessment of treatment satisfaction with the DTSQ
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of fear of hypoglycemia with the FH-15
Time frame: Baseline: Group 1 and 2
Assessment of fear of hypoglycemia with the FH-15
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of cost-effectiveness with a structured interview designed by our research group of direct and indirect costs.
Time frame: Baseline: Group 1 and 2; 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
Assessment of cost-effectiveness with a structured interview designed by our research group of direct and indirect costs.
Time frame: 6 months: Control (Group1a+Group 2b) vs Telemedicine ( Group 2a+ Group1b)
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