Effectiveness of a Multidisciplinary Treatment and Structured Education for Type 1 Diabetes Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes
- Sponsor
- Instituto Mexicano del Seguro Social
- Enrollment
- 120
- Primary Endpoint
- Changes in Glycemic Control Measured by A1c
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
David Sanchez Garcia
Principal investigator
Instituto Mexicano del Seguro Social
Eligibility Criteria
Inclusion Criteria
- •Type 1 diabetes
- •Diabetes duration \>1 year
- •BMI 18.5-40kg/m2
- •A1c 6.5-13%
Exclusion Criteria
- •Pregnancy
- •Dementia or severe cognitive impairment
- •Uncontrolled psychiatric disorder
- •Absence of \>20% of the educational sessions
Outcomes
Primary Outcomes
Changes in Glycemic Control Measured by A1c
Time Frame: Baseline and 6 months
Difference between baseline A1c and A1c at 6 month follow up
Secondary Outcomes
- Changes in Lipid Control Measured by LDLc, HDLc, non-HDLc, Triglycerides, Total Cholesterol(Baseline and 6 months)
- Changes in insulin resistance control Measured by eGDR(Baseline and 6 months)
- Changes Anthropometry Measured by BMI and WC(Baseline and 6 months)
- Changes in Glycemic Control Measured by severe hypoglycemia(Baseline and 6 months)
- Changes in Mental health Measured by DDS, GAD7 and PHQ9(Baseline and 6 months)