Sublingual Microcirculation in Children With Compensated T1D Using the SDF Method

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type1diabetes

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: type 1 diabetes mellitus informed consent of parents Exclusion Criteria: acute infection period of metabolic decompensation and 14 days after it

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preschool children<br>10 preschool children with T1D aged 3-5,9 years. | |
| Children of younger school age<br>10 children of younger school age aged 6-10,9 years with T1D. | |
| Children in puberty<br>10 children in puberty aged 11-14,9 years with T1D | |
| Postpubertal adolescents<br>10 postpubertal adolescents aged 15-18,9 years with T1D | |

What is the study measuring?
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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. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Total Vascular Density of sublingual microcirculation in different age and gender categories in children with T1D | Comparison in children aged 3-5,9; 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 3-5,9; 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 3-5,9; 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 3-5,9; 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 3-5,9; 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 3-5,9; 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 3-5,9; 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 3-5,9; 6-10,9; 11-14,9; and 15-18,9 years and males vs. females. | baseline | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microcirculation, Children, Type1diabetes