Effectiveness of a Multidisciplinary Treatment and Structured Education Programme

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06184815
• Other study ID #: IMSST1D
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: December 2023
• Source: Instituto Mexicano del Seguro Social
• Contact: David Sanchez, MD
• Phone: 8183714100
• Email: davidsanchez70[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: November 30, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Educational programme 12
Consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months and multidisciplinary treatment
• Standard education and treatment
Outpatient management and education in the office and consultation referral to nutrition and psychology

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Glycemic Control Measured by A1c	Difference between baseline A1c and A1c at 6 month follow up	Baseline and 6 months
Secondary	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
Secondary	Changes in insulin resistance control Measured by eGDR	Difference between basal eGDR and eGDR at 6 month follow up	Baseline and 6 months
Secondary	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
Secondary	Changes Anthropometry Measured by BMI and WC	Difference between basal BMI and WC and BMI and WC at 6 months	Baseline and 6 months
Secondary	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