Sublingual Microcirculation in Children with Compensated T1D Using the SDF Method

Last updated: October 16, 2024
Sponsor: Vlasta Krausová
Overall Status: Completed

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Treatment

N/A

Clinical Study ID

NCT05958264
310/1
  • Ages 3-18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • type 1 diabetes mellitus

  • informed consent of parents

Exclusion

Exclusion Criteria:

  • acute infection

  • period of metabolic decompensation and 14 days after it

Study Design

Total Participants: 30
Study Start date:
February 01, 2023
Estimated Completion Date:
September 15, 2024

Study 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.

Connect with a study center

  • Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

    Ústí Nad Labem,
    Czechia

    Site Not Available

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