Sublingual Microcirculation in Children with Compensated T1D Using the SDF Method

Evaluation of Sublingual Microcirculation Using Sidestream Dark-Field Imaging in Children with Type 1 Diabetes Mellitus with Favorable Treatment Outcomes.

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.

Study Overview

• Status: Completed
• Conditions: Type1diabetes

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will include 40 children with T1D. Of these, 10 pre-school children (3-5.9 years), 10 younger school children (6-10.9 years), 10 children in puberty(11-14.9 years) and 10 post-puberty adolescents will be included (15-18.9 years).

Description

Inclusion Criteria:

• type 1 diabetes mellitus
• informed consent of parents

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Children of younger school age; 10 children of younger school age aged 6-10,9 years with T1D.
Children in puberty; 10 children in puberty aged 11-14,9 years with T1D
Postpubertal adolescents; 10 postpubertal adolescents aged 15-18,9 years with T1D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of Total Vascular Density of sublingual microcirculation of children with T1D	Total length of vessels divided by total surface of area	baseline
Determination of Microvascular Flow Index (MFI) of sublingual microcirculation of children with T1D	The image is divided into four quadrants and the predominant type of flow (absent = 0, intermittent = 1, sluggish = 2, normal = 3, and hyperdynamic = 4) is assessed in each quadrant. The MFI score represents the averaged values of the four. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).	baseline
Determination of Small Vessel Density of sublingual microcirculation of children with T1D	Total length of small vessels divided by total surface of area. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).	baseline
Determination of Proportion of Perfused Vessels (all) of sublingual microcirculation of children with T1D	The proportion of perfused vessels (PPV [%]) can be calculated as follows: 100 × (total number of vessels - [no flow + intermittent flow])/total number of vessels.	baselina
Determination of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation of children with T1D	The proportion of perfused small vessels (PPSV [%]) can be calculated as follows: 100 × (total number of small vessels - [no flow + intermittent flow])/total number of small vessels. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).	baseline
Determination of Perfused Vessel Density (PVD) of sublingual microcirculation of children with T1D	Total length of vessels - (no flow + intermittent flow) divided by total surface of area	baseline
Determination of Perfused Small Vessel Density (PSVD) of sublingual microcirculation of children with T1D	Total length of small vessels - (small vessels with no flow + intermittent flow) divided by total surface of area. A 20 μm cut-off is used to separate small vessels (mostly capillaries) from large vessels (mostly venules).	baseline
Determination of DeBacker Score of sublingual microcirculation of children	In this score, three equidistant horizontal and three equidistant vertical lines are drawn on the screen. Vessel density can be calculated as the number of vessels crossing the lines divided by the total length of the lines. Higher number means better microcirculation.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of Total Vascular Density of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Correlation of Microvascular Flow Index (MFI) of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Correlation of Small Vessel Density of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Correlation of Proportion of Perfused Vessels (all) of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Correlation of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Correlation of Perfused Vessel Density (PVD) of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Correlation of Perfused Small Vessel Density (PSVD) of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Correlation of DeBacker Score of sublingual microcirculation with parameters of diabetic compenzation	Comparison of parametes in children with good and bad compenzation of T1D	baseline
Differences of Total Vascular Density of sublingual microcirculation with parameters of healthy children in the same age categories	Total Vascular Density of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Differences of Microvascular Flow Index (MFI) of sublingual microcirculation with parameters of healthy children in the same age categories	Microvascular Flow Index (MFI) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Differences of Small Vessel Density of sublingual microcirculation with parameters of healthy children in the same age categories	Small Vessel Density of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Differences of Proportion of Perfused Vessels (all) of sublingual microcirculation with parameters of healthy children in the same age categories	Proportion of Perfused Vessels (all) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Differences of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation with parameters of healthy children in the same age categories	Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Differences of Perfused Vessel Density (PVD) of sublingual microcirculation with parameters of healthy children in the same age categories	Perfused Vessel Density (PVD) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Differences of Perfused Small Vessel Density (PSVD) of sublingual microcirculation with parameters of healthy children in the same age categories	Perfused Small Vessel Density (PSVD) of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Differences of DeBacker Score of sublingual microcirculation with parameters of healthy children in the same age categories	DeBacker Score of sublingual microcirculation of healthy children has been obtained previously within study NCT05324228	baseline
Differences in Total Vascular Density of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.	baseline
Differences in Microvascular Flow Index (MFI) of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.	baseline
Differences in Small Vessel Density of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.	baseline
Differences Proportion of Perfused Vessels (all) of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.	baseline
Differences in Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.	baseline
Differences in Perfused Vessel Density (PVD) of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.	baseline
Differences in Perfused Small Vessel Density (PSVD) of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females.	baseline
Differences in DeBacker Score of sublingual microcirculation in different age and gender categories in children with T1D	Comparison in children aged 6-10,9; 11-14,9; and 15-18,9 years and males vs. females. Higher number means better microcirculation.	baseline

Collaborators and Investigators

• Sponsor: Vlasta Krausová
• Investigators: Study Chair: David Neumann, MD, Ph.D., Hospital in Trutnov

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): September 15, 2024
• Study Completion (Actual): September 15, 2024

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Type1diabetes; Children; Microcirculation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 310/1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No