Effectiveness of a Multidisciplinary Treatment and Structured Education Programme

NCT06184815 | Unknown DMC

• 1 other identifier: IMSST1D
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; Autoimmune Diseases; Diabetes; Education Programme; DSMES; Diabetes self-management education and support; T1D; Insulin-dependent diabetes; Juvenile diabetes

Outcome Measures

Primary Outcomes (1)

• Changes in Glycemic Control Measured by A1c

  Difference between baseline A1c and A1c at 6 month follow up

  Baseline and 6 months

Secondary Outcomes (5)

• Changes in Lipid Control Measured by LDLc, HDLc, non-HDLc, Triglycerides, Total Cholesterol

  Baseline and 6 months

• Changes in insulin resistance control Measured by eGDR

  Baseline and 6 months

• Changes in Mental health Measured by DDS, GAD7 and PHQ9

  Baseline and 6 months

• Changes Anthropometry Measured by BMI and WC

  Baseline and 6 months

• Changes in Glycemic Control Measured by severe hypoglycemia

  Baseline and 6 months

Study Arms (2)

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.

Behavioral: Educational programme 12

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

Behavioral: Standard education and treatment

Interventions

Educational programme 12 BEHAVIORAL

Consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months and multidisciplinary treatment

Educational programme 12

Standard education and treatment BEHAVIORAL

Outpatient management and education in the office and consultation referral to nutrition and psychology

Also known as: Standard

Standard

Eligibility Criteria

• Age: 15 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes
• Diabetes duration \>1 year
• BMI 18.5-40kg/m2
• A1c 6.5-13%

You may not qualify if:

• Pregnancy
• Dementia or severe cognitive impairment
• Uncontrolled psychiatric disorder
• Absence of \>20% of the educational sessions

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Autoimmune Diseases; Diabetes Mellitus

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Immune System Diseases

Study Officials

• David Sanchez, MD

  Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25 Monterrey, Mexico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Sanchez, MD

CONTACT

8183714100; davidsanchez70@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: December 28, 2023
• Study Start: January 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 30, 2024
• Last Updated: December 28, 2023

Record last verified: 2023-12