Effectiveness of a Multidisciplinary Treatment and Structured Education Programme

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effectiveness of a Multidisciplinary Treatment and Structured Education for Type 1 Diabetes Patients

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Educational programme 12
* Behavioral: Standard education and treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational programme 12<br>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<br>* Consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months and multidisciplinary treatment<br>|
| Active Comparator: Standard<br>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<br>* Outpatient management and education in the office and consultation referral to nutrition and psychology<br>* Other names: Standard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, Autoimmune Diseases, Diabetes, Education Programme, DSMES, Diabetes self-management education and support, T1D, Insulin-dependent diabetes, Juvenile diabetes