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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational programme 12 | Experimental | 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. |
|
| Standard | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational programme 12 | Behavioral | Consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months and multidisciplinary treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Glycemic Control Measured by A1c | Difference between baseline A1c and A1c at 6 month follow up | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and 6 months |
| Changes in insulin resistance control Measured by eGDR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Sanchez, MD | Contact | 8183714100 | 41315 | davidsanchez70@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| David Sanchez, MD | Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25 Monterrey, Mexico | Principal Investigator |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D001327 | Autoimmune Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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.
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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.
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| Standard education and treatment | Behavioral | Outpatient management and education in the office and consultation referral to nutrition and psychology |
|
|
Difference between basal eGDR and eGDR at 6 month follow up
| 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 | Baseline and 6 months |
| Changes Anthropometry Measured by BMI and WC | Difference between basal BMI and WC and BMI and WC at 6 months | 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 | Baseline and 6 months |
| D007154 | Immune System Diseases |