Sublingual Microcirculation in Children with Compensated T1D Using the SDF Method

Vlasta Krausová

Status: Completed

Conditions: Type1diabetes

Study type: Observational

Funder types: Other

Identifiers

NCT05958264

310/1

Details and patient eligibility

About

The main goal of the study is to describe the sublingual microcirculation of children with type 1 diabetes mellitus (T1D) with stable and satisfactory treatment of the disease and to compare it with previously measured parameters of healthy children, NCT05324228.

Full description

After recording the basic anthropometric parameters, pressure and pulse, each child who meets the inclusion criteria will have their microcirculation measured using a Sidestream Dark-Field (SDF) probe placed sublingually by one examiner using the SDF method. The measurement will be performed in supine position in a disease-free period, with normal diets, at least 2 hours after the last meal, for girls outside the menses period. Premedication or analgesia will not be used. A total of 3 video clips will be recorded from different parts of the sublingual area with a minimum length of 20 seconds in a row, unless the child needs a short break between measurements. The recorded videos will then be processed offline by one evaluator who is trained and experienced in microcirculation evaluation, three best and most stable parts of each video clip will be analysed.

Enrollment: 30 patients

Sex: All

Ages: 3 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• type 1 diabetes mellitus
• informed consent of parents

Exclusion criteria

• acute infection
• period of metabolic decompensation and 14 days after it

Trial design

30 participants in 3 patient groups

Children of younger school age

Description:

10 children of younger school age aged 6-10,9 years with T1D.

Children in puberty

Description:

10 children in puberty aged 11-14,9 years with T1D

Postpubertal adolescents

Description:

10 postpubertal adolescents aged 15-18,9 years with T1D