This trial compared an structured education programme and multidisciplinary treatment vs an standard treatment in type 1 diabetes patient, the Primary outcome is glycemic control at 6-month follow up and secondary outcome are cardiovascular risk factors control, diabetes related distress, anxiety and depressive symptoms, hypoglycemia awareness.
Both groups will received individualized treatment in the clinic, the intervention group will consist of 12 educational sessions during 4 months, and multidisciplinary treatment each month given by endocrinology, nutrition and psychology during 4 months, the control group will received education in outpatient clinic of endocrinology and will be sent as referral to specialties of nutrition and psychology as standard follow-up of the clinic.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months and multidisciplinary treatment
Outpatient management and education in the office and consultation referral to nutrition and psychology
Changes in Glycemic Control Measured by A1c
Difference between baseline A1c and A1c at 6 month follow up
Time frame: Baseline and 6 months
Changes in Lipid Control Measured by LDLc, HDLc, non-HDLc, Triglycerides, Total Cholesterol
Difference between basal lipid profile and lipid profile at 6 month follow up
Time frame: Baseline and 6 months
Changes in insulin resistance control Measured by eGDR
Difference between basal eGDR and eGDR at 6 month follow up
Time frame: Baseline and 6 months
Changes in Mental health Measured by DDS, GAD7 and PHQ9
Difference between basal DDS, GAD7 and PHQ9 and DDS, GAD7 and PHQ9 at 6 month follow up
Time frame: Baseline and 6 months
Changes Anthropometry Measured by BMI and WC
Difference between basal BMI and WC and BMI and WC at 6 months
Time frame: Baseline and 6 months
Changes in Glycemic Control Measured by severe hypoglycemia
Difference between severe hypoglycemia in the las 6 months and severe hypoglycemia at 6 months of follow up
Time frame: Baseline and 6 months
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