An interventional study of Educational programme 12 and Standard education and treatment in Type 1 Diabetes, sponsored by Instituto Mexicano del Seguro Social. Not yet recruiting. Open to participants aged 15 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-28.
Sponsored by Instituto Mexicano del Seguro Social · Not applicable, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 120 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Instituto Mexicano del Seguro Social is the lead sponsor of 124 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The educational programme consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months. The multidisciplinary treatment consists of 4, each one every month, consultations of specialties of nutrition, endocinrology and psychology.
Behavioral: Educational programme 12
The standard educational program consists of outpatient management with diabetic education slides and material for the patient, with a duration of 4 months. Standard treatment consists of endocrinology consultation with nutrition and psychology referral if required
Behavioral: Standard education and treatment
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
Also known as: Standard
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
No study locations are listed for this record.
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Instituto Mexicano del Seguro Social