Effectiveness of a Multidisciplinary Treatment and Structured Education Programme

December 15, 2023 updated by: David Sanchez Garcia, Instituto Mexicano del Seguro Social

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Educational programme 12
Consists of 12 lessons, diabetes education slides and patient materials, with a duration of 4 months and multidisciplinary treatment
Active Comparator: Standard
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
Outpatient management and education in the office and consultation referral to nutrition and psychology
Other Names:
  • Standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Glycemic Control Measured by A1c
Time Frame: Baseline and 6 months
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
Time Frame: Baseline and 6 months
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
Time Frame: Baseline and 6 months
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
Time Frame: Baseline and 6 months
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
Time Frame: Baseline and 6 months
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
Time Frame: Baseline and 6 months
Difference between severe hypoglycemia in the las 6 months and severe hypoglycemia at 6 months of follow up
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • Principal Investigator: David Sanchez, MD, Centro Médico Nacional del Noreste Hospital de Especialidades UMAE 25 Monterrey, Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2024

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Actual)

December 28, 2023

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMSST1D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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