Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, Autoimmune Diseases, Diabetes, Education Programme, DSMES, Diabetes self-management education and support, T1D, Insulin-dependent diabetes, Juvenile diabetes
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.
Interventions
BEHAVIORALEducational programme 12
Consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months and multidisciplinary treatment
BEHAVIORALStandard education and treatment
Outpatient management and education in the office and consultation referral to nutrition and psychology
Sponsors
Instituto Mexicano del Seguro Social
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
The standard educational and treatment program consists of outpatient management and education in the office and consultation referral to nutrition and psychology with a duration of 4 months.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Glycemic Control Measured by A1c | Baseline and 6 months | Difference between baseline A1c and A1c at 6 month follow up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Lipid Control Measured by LDLc, HDLc, non-HDLc, Triglycerides, Total Cholesterol | Baseline and 6 months | Difference between basal lipid profile and lipid profile at 6 month follow up |
| Changes in insulin resistance control Measured by eGDR | Baseline and 6 months | Difference between basal eGDR and eGDR at 6 month follow up |
| Changes in Mental health Measured by DDS, GAD7 and PHQ9 | Baseline and 6 months | Difference between basal DDS, GAD7 and PHQ9 and DDS, GAD7 and PHQ9 at 6 month follow up |
| Changes Anthropometry Measured by BMI and WC | Baseline and 6 months | Difference between basal BMI and WC and BMI and WC at 6 months |
| Changes in Glycemic Control Measured by severe hypoglycemia | Baseline and 6 months | Difference between severe hypoglycemia in the las 6 months and severe hypoglycemia at 6 months of follow up |
Contacts
Primary ContactDavid Sanchez, MD
Outcome results
None listed