Effectiveness of a Multidisciplinary Treatment and Structured Education Programme

Not Applicable

Not yet recruiting

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Educational programme 12; Behavioral: Standard education and treatment

• Registration Number: NCT06184815
• Lead Sponsor: Instituto Mexicano del Seguro Social

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.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-15
• Last Update Submitted: 2023-12-15
• Study First Posted: 2023-12-28
• Last Update Posted: 2023-12-28
• Study Start: 2024-01-01
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational programme 12	Educational programme 12	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	Standard education and treatment	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

Primary Outcome Measures

Name	Time	Method
Changes in Glycemic Control Measured by A1c	Baseline and 6 months	Difference between baseline A1c and A1c at 6 month follow up

Secondary Outcome Measures

Name	Time	Method
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 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
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