Type1diabetesNCT05958264
Sublingual Microcirculation in Children with Compensated T1D Using the SDF Method
An observational study of Type1diabetes, run by Vlasta Krausová at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Type1diabetes
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2023to 15 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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).
Who may be able to join
- type 1 diabetes mellitus
- informed consent of parents
Who cannot join
- acute infection
- period of metabolic decompensation and 14 days after it
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Ústí nad Labem
About this study
Official title: 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.
Read the 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.
- Conditions
- Type1diabetes
- Keywords
- Microcirculation, Children, Type1diabetes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Determination of Total Vascular Density of sublingual microcirculation of children with T1D
Total length of vessels divided by total surface of area
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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).
Measured: 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.
Measured: baseline
Secondary outcomes (24)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start1 Feb 2023
- Primary completion15 Sep 2024
- Study completion15 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vlasta Krausová
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vlasta Krausová, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Investigators
- David Neumann, MD, Ph.D., Study chair, Hospital in Trutnov
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05958264
- Sponsor's protocol ID
- 310/1
- Status last verified
- Oct 2024
- First submitted
- 28 Jun 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Krausova V, Neumann D, Stichova L, Skvor J, Dostalova V, Dostal P. Alterations of Sublingual Microcirculation in Children With Compensated Type 1 Diabetes Mellitus-An Observational Study. Pediatr Diabetes. 2025 Sep 30;2025:8811411. doi: 10.1155/pedi/8811411. eCollection 2025.
PubMed 41064468
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sublingual Microcirculation Using Sidestream Dark-Field Imaging in Children with Type 1 Diabetes Mellitus with Favorable Treatment Outcomes.
- ClinicalTrials.gov ID
- NCT05958264
- Acronym / sponsor ID
- 310/1
- Conditions
- Type1diabetes
- Keywords
- Microcirculation, Children, Type1diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vlasta KrausováUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Sep 2024 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (2 listed)
- type 1 diabetes mellitus
- informed consent of parents
Key exclusion criteria (2 listed)
- acute infection
- period of metabolic decompensation and 14 days after it
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of Total Vascular Density of sublingual microcirculation of children with T1D
Time frame: baseline
Total length of vessels divided by total surface of area
Determination of Microvascular Flow Index (MFI) of sublingual microcirculation of children with T1D
Time frame: baseline
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).
Determination of Small Vessel Density of sublingual microcirculation of children with T1D
Time frame: baseline
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).
Determination of Proportion of Perfused Vessels (all) of sublingual microcirculation of children with T1D
Time frame: baselina
The proportion of perfused vessels (PPV [%]) can be calculated as follows: 100 × (total number of vessels - [no flow + intermittent flow])/total number of vessels.
Determination of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation of children with T1D
Time frame: baseline
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).
Determination of Perfused Vessel Density (PVD) of sublingual microcirculation of children with T1D
Time frame: baseline
Total length of vessels - (no flow + intermittent flow) divided by total surface of area
Determination of Perfused Small Vessel Density (PSVD) of sublingual microcirculation of children with T1D
Time frame: baseline
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).
Determination of DeBacker Score of sublingual microcirculation of children
Time frame: baseline
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.
24 secondary outcomes
Differences in Total Vascular Density of sublingual microcirculation in different age and gender categories in children with T1D
Time frame: baseline
Differences in Microvascular Flow Index (MFI) of sublingual microcirculation in different age and gender categories in children with T1D
Time frame: baseline
Differences in Small Vessel Density of sublingual microcirculation in different age and gender categories in children with T1D
Time frame: baseline
Differences Proportion of Perfused Vessels (all) of sublingual microcirculation in different age and gender categories in children with T1D
Time frame: baseline
Differences in Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation in different age and gender categories in children with T1D
Time frame: baseline
Differences in Perfused Vessel Density (PVD) of sublingual microcirculation in different age and gender categories in children with T1D
Time frame: baseline
Differences in Perfused Small Vessel Density (PSVD) of sublingual microcirculation in different age and gender categories in children with T1D
Time frame: baseline
Differences in DeBacker Score of sublingual microcirculation in different age and gender categories in children with T1D
Time frame: baseline
Correlation of Total Vascular Density of sublingual microcirculation with parameters of diabetic compenzation
Time frame: baseline
Correlation of Microvascular Flow Index (MFI) of sublingual microcirculation with parameters of diabetic compenzation
Time frame: baseline
Correlation of Small Vessel Density of sublingual microcirculation with parameters of diabetic compenzation
Time frame: baseline
Correlation of Proportion of Perfused Vessels (all) of sublingual microcirculation with parameters of diabetic compenzation
Time frame: baseline
Correlation of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation with parameters of diabetic compenzation
Time frame: baseline
Correlation of Perfused Vessel Density (PVD) of sublingual microcirculation with parameters of diabetic compenzation
Time frame: baseline
Correlation of Perfused Small Vessel Density (PSVD) of sublingual microcirculation with parameters of diabetic compenzation
Time frame: baseline
Correlation of DeBacker Score of sublingual microcirculation with parameters of diabetic compenzation
Time frame: baseline
Differences of Total Vascular Density of sublingual microcirculation with parameters of healthy children in the same age categories
Time frame: baseline
Differences of Microvascular Flow Index (MFI) of sublingual microcirculation with parameters of healthy children in the same age categories
Time frame: baseline
Differences of Small Vessel Density of sublingual microcirculation with parameters of healthy children in the same age categories
Time frame: baseline
Differences of Proportion of Perfused Vessels (all) of sublingual microcirculation with parameters of healthy children in the same age categories
Time frame: baseline
Differences of Proportion of Perfused Small Vessels (PPSV) of sublingual microcirculation with parameters of healthy children in the same age categories
Time frame: baseline
Differences of Perfused Vessel Density (PVD) of sublingual microcirculation with parameters of healthy children in the same age categories
Time frame: baseline
Differences of Perfused Small Vessel Density (PSVD) of sublingual microcirculation with parameters of healthy children in the same age categories
Time frame: baseline
Differences of DeBacker Score of sublingual microcirculation with parameters of healthy children in the same age categories
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Derived from this study: PubMed 41064468Krausova V, Neumann D, Stichova L, Skvor J, Dostalova V, Dostal P. Alterations of Sublingual Microcirculation in Children With Compensated Type 1 Diabetes Mellitus-An Observational Study. Pediatr Diabetes. 2025 Sep 30;2025:8811411. doi: 10.1155/pedi/8811411. eCollection 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Neumann, MD, Ph.D. study chair
Hospital in Trutnov
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type1diabetes, run by Vlasta Krausová at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of Total Vascular Density of sublingual microcirculation of children with T1D (time frame: baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05958264, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.