Effectiveness of a Multidisciplinary Treatment and Structured Education Programme

Instituto Mexicano del Seguro Social

Status: Not yet enrolling

Conditions: Type 1 Diabetes

Treatments: Behavioral: Standard education and treatment; Behavioral: Educational programme 12

Study type: Interventional

Funder types: Other

Identifiers

NCT06184815

IMSST1D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 15 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Educational programme 12

Experimental group

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.

Treatment:

Behavioral: Educational programme 12

Standard

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard education and treatment