Diabetes Type 1NCT06989190
The MIND Study - Microangiopathy IN Diabetes
An observational study of Diabetes Type 1, run by HJN Sverige AB/Neko Health at 1 site in Sweden.
Trial summary
This clinical investigation will evaluate two contactless optical devices based on spatial frequency domain and laser speckle technology for quantification of the skin micro-circulation in patients with diabetes mellitus type 1. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Type 1
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 19 Dec 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with type 1 diabetes will be recruited from the diabetes clinic at Danderyd Hospital, which currently follows around 1800 patients with type 1 diabetes. All patients matching the inclusion criteria will be asked to participate in the study by a doctor or nurse at their routine visit to the clinic. Responsible doctor or research nurse will also screen for suitable patients registered at the clinic, and call the patients that meet inclusion criteria to see if they would like to participate in the study after a short description of the study's purpose and setup. Recruitment of the control group will occur through digital advertisement, e.g. on the Karolinska Institute website.
Who may be able to join
- Severe type 1 diabetes (microangiopathy / diabetic feet), severe angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers.
- Age range: primarily 18-45 years, if not sufficient number of subjects can be found, then 18-60 years span is considered
- Phase 2: Scale of severity. In phase 2, patients are included with a broad range of severity levels. Patients with diabetes type 1 will be included.
- Age range: 18-45 years (younger patients are targeted for focus on microvascular complications, rather than age-related cardiovascular disease)
- Patient with no microangiopathy, except for simplex or background retinopathy, which is in an early and reversible state (group a), 100 patients.
- Patient with mild microangiopathy, mild-moderate non-proliferative retinopathy and/or microalbuminuria and/or early signs of neuropathy (group b), 100 patients.
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- Patient with moderate microangiopathy. moderate non-proliferative retinopathy or proliferative retinopathy, macroalbuminuria or kidney failure (defined as estimated glomerular filtration rate <60 mL/min/1.73 m2 body surface) up to CKD-class 3A, and manifest neuropathy, (group c), 50 patients.
- Healthy controls:
- Healthy control matched to the type 1 diabetes patients in age and gender, with no known risk of increased cardiovascular disease.
Who cannot join
- Patients unable to understand patient information due to cognitive impairment
- Patients unable to understand patient information due to language barriers
- Ongoing acute infection or inflammatory condition
- Pregnant or breastfeeding women
- Patients with damaged and/or scarred tissue in the areas of interest for the investigational or comparator devices
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
VO Medicinska Specialiteter, Danderyd Hospital
Stockholm, 182 88
Sara Tehrani, MD, PhD, +46 73 679 70 74, sara.tehrani@regionstockholm.se
About this study
This clinical investigation will evaluate two contactless optical devices based on spatial frequency domain and laser speckle technology for quantification of the skin micro-circulation in patients with diabetes mellitus type 1.
Read the detailed description
This clinical feasibility study aims to evaluate the potential of contactless and non-invasive technologies for measurement of skin microcirculatory properties and their regulatory function in healthy individuals and patients with diabetes type 1. The clinical investigation incorporates two investigational devices:
- Neko Health TCI P4: a contactless optical device based on SFDI technology, to be used for quantification of the skin microcirculation via molecular composition, such as haemoglobin / blood volume and oxygen concentrations.
- Perimed Multiflow: a contactless optical device based on laser speckle technology, to be used for quantification of the skin micro-circulation via speed resolved perfusion based on movement of the red blood cells.
These technologies are promising tools for diagnostic support of pathology in the microcirculation, such as diabetic microangiopathy. Since they are imaging technologies, collecting data over a two-dimensional surface of the skin; they may be more robust than single-point measurements as well as allowing for quantification of differences and distribution over different skin sections.
The two investigational devices are good complements, as the TCI P4 can quantify composition (concentration of molecules) and the MultiFlow can quantify flow properties (perfusion), this way one gets a good foundation to study the key properties of the micro-circulation: blood volume, oxygenation and hemodynamics.
The state of the art concerning diabetic complications and PAD (Peripheral Arterial Disease) in clinical practice is currently not proactive, but rather aimed towards reactive treatment, management, and monitoring during the later phase of tissue damage and microvascular impairment. The aim with the investigation is to find indication of disease / pathology at an early stage, by evaluation of parameters / physiological changes before manifestation of clinical complications. The state-of-the-art guidelines on diagnosis, prognosis, and management of PAD in patients with foot ulcers and diabetes are well described in the 2023 WGDF Guidelines on the Prevention and Management of Diabetes-related Foot Disease. These guidelines are based on pressure-based measurements, ABI (Ankle Brachial Index), TBI (Toe Brachial Index) and tcpO2. The pathophysiological features of PAD and diabetes foot ulcers is primarily due to altered blood perfusion and tissue oxygenation whereas the investigational device is assessing the micro-circulation (smaller vessels). However, since the micro-circulation is connected downstream to the larger vessels (macro-circulation) its perfusion will be affected by both macro- and micro-circulatory factors. Therefore, the investigational device may enable finding early indications of pathology regardless of if the issue starts in the macro- or micro-circulation. Furthermore, micro-circulatory changes correlated to PAD and diabetes in skin tissue has been proven in published research, for skin in feet [1], as well as skin in the forearm [2], [3].
The hypotheses will be analysed by correlation analysis (simple regression coefficients) between physiological response and the measured parameters, along with other analytical methods suitable for understanding these correlations. Interpretation of the observed physiological response will be based on theoretical background as well as results from the comparator devices. Data of patients with diabetes type 1 and different severities of clinical microangiopathy will be compared to healthy controls, in order to see if responses are altered by diabetes microangiopathy and if they can be isolated from normal variation in the control group.
Furthermore, the hypothesis is also that different body sites are affected differently and at different stages of pathology, due to the local properties and environment of the different sites. The relation in properties between the sites may also be altered by diabetes microangiopathy. For example, peripheral body sites are usually seen to be affected first by pathology. The following body sites will be investigated:
- Volar side of forearm
- Palm of hand
- Dorsal and plantar side of feet
The main outcomes are listed below, however all generated datatypes of each examination will be analysed for any correlations between them and the status of the patient, to ensure that important correlations and learnings are not missed, even if the specific correlation was not expected.
- Conditions
- Diabetes Type 1
- Medical subject headings
- Diabetes Mellitus, Type 1
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 |
|---|---|---|
| diabetes_severe_cohort | Patients with severe type 1 diabetes (microangiopathy / diabetic feet), with complications. Severe angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers. | |
| diabetes_moderate_cohort | Patients with type 1 diabetes and moderate microangiopathy. moderate non-proliferative retinopathy or proliferative retinopathy, macroalbuminuria or kidney failure (defined as estimated glomerular filtration rate <60 mL/min/1.73 m2 body surface) up to CKD-class 3A, and manifest neuropathy, (group c). | |
| diabetes_mild_cohort | Patient with mild microangiopathy, mild-moderate non-proliferative retinopathy and/or microalbuminuria and/or early signs of neuropathy (group b). | |
| diabetes_none_cohort | Patient with no microangiopathy, except for simplex or background retinopathy, which is in an early and reversible state (group a). | |
| healthy_cohort | Age- and sex- matched healthy controls, with no known increased risk of cardiovascular disease. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between investigational device-derived energy in endothelial band and endothelial pathology
Correlation between SFDI- and laser speckle-derived endothelial energy band (perfusion, oxygenation) and blood marker indication of endothelial cell /glycocalyx deterioration and/or endothelial cell response from iontophoresis provocation.
Measured: Same day as enrolment.
Correlation between investigational device-derived energy in the myogenic band in the case of hypertension and myogenic related pathology
Association between SFDI- and laser speckle-derived myogenic energy band and presence of hypertension, and/or indication of reduced smooth muscle cell response from iontophoresis provocation.
Measured: Same day as enrolment.
Correlation between investigational device-derived energy in the neurogenic band and indication of neuropathy
Correlation between SFDI- and laser speckle-derived neurogenic energy band and indication/diagnosis of neuropathy, based on clinical assessment or electronic health records.
Measured: Same day as enrolment.
Correlation between investigational device-derived brachial post-occlusive hyperemia (PORH) peak oxygenation and degree of neuropathic angiopathy
Correlation of investigational device-derived peak oxygen saturation amplitude from brachial PORH test against degree of microangiopathy/ microvascular complications.
Measured: Same day as enrolment.
Difference in response (perfusion) to mild local heat provocation between diabetes type 1 and healthy controls
Difference in IMD-derived variables of perfusion between healthy controls and patients with diabetes type 1 during mild local heat provocation (~30ᵒC).
Measured: Same day as enrolment.
Difference in response (oxygenation) to mild local heat provocation between diabetes type 1 and healthy controls
Difference in IMD-derived variables of oxygenation between healthy controls and patients with diabetes type 1 during mild local heat provocation (~30ᵒC).
Measured: Same day as enrolment.
Difference in response (hemoglobin concentration) to mild local heat provocation between diabetes type 1 and healthy controls
Difference in IMD-derived variables of hemoglobin concentration between healthy controls and patients with diabetes type 1 during mild local heat provocation (~30ᵒC).
Measured: Same day as enrolment.
Difference in response (perfusion) to increased local heat provocation between diabetes type 1 and healthy controls
Difference in IMD-derived variables of perfusion between healthy controls and patients with diabetes type 1 during increased local heat provocation (~35ᵒC).
Measured: Same day as enrolment.
Difference in response (oxygenation) to increased local heat provocation between diabetes type 1 and healthy controls
Difference in IMD-derived variables of oxygenation between healthy controls and patients with diabetes type 1 during increased local heat provocation (~35ᵒC).
Measured: Same day as enrolment.
Difference in response (hemoglobin concentration) to increased local heat provocation between diabetes type 1 and healthy controls
Difference in IMD-derived variables of hemoglobin concentration between healthy controls and patients with diabetes type 1 during increased local heat provocation (~35ᵒC).
Measured: Same day as enrolment.
Difference in response (perfusion) to high local heat provocation between diabetes type 1 and healthy controls
Difference in IMD-derived variables of perfusion between healthy controls and patients with diabetes type 1 during high local heat provocation (~40-44ᵒC).
Measured: Same day as enrolment.
Difference in response (oxygenation) to high local heat provocation between diabetes type 1 and healthy controls
Difference in IMD-derived variables of oxygenation between healthy controls and patients with diabetes type 1 during high local heat provocation (~40-44ᵒC).
Measured: Same day as enrolment.
Secondary outcomes (4)
Assessment of distribution of oxygenation in foot soles of patients with diabetic feet compared to healthy controls
Comparison of the distribution oxygenation on the foot sole in diabetic feet of risk level 2-4 (levels as set by national guidelines) and feet of healthy controls with no evidence of cardiovascular disease.
Measured: Same day as enrolment.
Assessment of distribution of perfusion in foot soles of patients with diabetic feet compared to healthy controls
Comparison of the distribution of perfusion on the foot sole in diabetic feet of risk level 2-4 (levels as set by national guidelines) and feet of healthy controls with no evidence of cardiovascular disease.
Measured: Same day as enrolment.
Assessment of if the addition of thermal provocation can increase contrasts between diabetic feet and feet of healthy controls
Comparison of the distribution during response to heat provocation in diabetic feet compared to feet of healthy controls to assess contribution to differences between groups.
Measured: Same day as enrolment.
Assessment of if the addition of investigational device-derived water concentration data can increase contrasts between diabetic feet and feet of healthy controls
Comparison of the distribution of other variables such as SFDI-derived water concentration in diabetic feet compared to feet of healthy controls to assess contribution to differences between groups.
Measured: Same day as enrolment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start19 Dec 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 1Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HJN Sverige AB/Neko Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Tehrani, MD, PhD, Principal investigator, Danderyd Hospital, Department of Internal Medicine, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989190
- Sponsor's protocol ID
- CIV-23-02-042193
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jonasson H, Bergstrand S, Fredriksson I, Larsson M, Ostgren CJ, Stromberg T. Post-ischemic skin peak oxygen saturation is associated with cardiovascular risk factors: a Swedish cohort study. Microvasc Res. 2022 Mar;140:104284. doi: 10.1016/j.mvr.2021.104284. Epub 2021 Nov 23.
PubMed 34826433Murphy GA, Singh-Moon RP, Mazhar A, Cuccia DJ, Rowe VL, Armstrong DG. Quantifying dermal microcirculatory changes of neuropathic and neuroischemic diabetic foot ulcers using spatial frequency domain imaging: a shade of things to come? BMJ Open Diabetes Res Care. 2020 Nov;8(2):e001815. doi: 10.1136/bmjdrc-2020-001815.
PubMed 33219118
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MIND Study - Microangiopathy IN Diabetes
- ClinicalTrials.gov ID
- NCT06989190
- Acronym / sponsor ID
- CIV-23-02-042193
- Conditions
- Diabetes Type 1
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- HJN Sverige AB/Neko HealthIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 May 2025 (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.
This clinical investigation will evaluate two contactless optical devices based on spatial frequency domain and laser speckle technology for quantification of the skin micro-circulation in patients with diabetes mellitus type 1.
Detailed description
This clinical feasibility study aims to evaluate the potential of contactless and non-invasive technologies for measurement of skin microcirculatory properties and their regulatory function in healthy individuals and patients with diabetes type 1. The clinical investigation incorporates two investigational devices:
- Neko Health TCI P4: a contactless optical device based on SFDI technology, to be used for quantification of the skin microcirculation via molecular composition, such as haemoglobin / blood volume and oxygen concentrations.
- Perimed Multiflow: a contactless optical device based on laser speckle technology, to be used for quantification of the skin micro-circulation via speed resolved perfusion based on movement of the red blood cells.
These technologies are promising tools for diagnostic support of pathology in the microcirculation, such as diabetic microangiopathy. Since they are imaging technologies, collecting data over a two-dimensional surface of the skin; they may be more robust than single-point measurements as well as allowing for quantification of differences and distribution over different skin sections.
The two investigational devices are good complements, as the TCI P4 can quantify composition (concentration of molecules) and the MultiFlow can quantify flow properties (perfusion), this way one gets a good foundation to study the key properties of the micro-circulation: blood volume, oxygenation and hemodynamics.
The state of the art concerning diabetic complications and PAD (Peripheral Arterial Disease) in clinical practice is currently not proactive, but rather aimed towards reactive treatment, management, and monitoring during the later phase of tissue damage and microvascular impairment. The aim with the investigation is to find indication of disease / pathology at an early stage, by evaluation of parameters / physiological changes before manifestation of clinical complications. The state-of-the-art guidelines on diagnosis, prognosis, and management of PAD in patients with foot ulcers and diabetes are well described in the 2023 WGDF Guidelines on the Prevention and Management of Diabetes-related Foot Disease. These guidelines are based on pressure-based measurements, ABI (Ankle Brachial Index), TBI (Toe Brachial Index) and tcpO2. The pathophysiological features of PAD and diabetes foot ulcers is primarily due to altered blood perfusion and tissue oxygenation whereas the investigational device is assessing the micro-circulation (smaller vessels). However, since the micro-circulation is connected downstream to the larger vessels (macro-circulation) its perfusion will be affected by both macro- and micro-circulatory factors. Therefore, the investigational device may enable finding early indications of pathology regardless of if the issue starts in the macro- or micro-circulation. Furthermore, micro-circulatory changes correlated to PAD and diabetes in skin tissue has been proven in published research, for skin in feet [1], as well as skin in the forearm [2], [3].
The hypotheses will be analysed by correlation analysis (simple regression coefficients) between physiological response and the measured parameters, along with other analytical methods suitable for understanding these correlations. Interpretation of the observed physiological response will be based on theoretical background as well as results from the comparator devices. Data of patients with diabetes type 1 and different severities of clinical microangiopathy will be compared to healthy controls, in order to see if responses are altered by diabetes microangiopathy and if they can be isolated from normal variation in the control group.
Furthermore, the hypothesis is also that different body sites are affected differently and at different stages of pathology, due to the local properties and environment of the different sites. The relation in properties between the sites may also be altered by diabetes microangiopathy. For example, peripheral body sites are usually seen to be affected first by pathology. The following body sites will be investigated:
- Volar side of forearm
- Palm of hand
- Dorsal and plantar side of feet
The main outcomes are listed below, however all generated datatypes of each examination will be analysed for any correlations between them and the status of the patient, to ensure that important correlations and learnings are not missed, even if the specific correlation was not expected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| diabetes_severe_cohort | – | –Patients with severe type 1 diabetes (microangiopathy / diabetic feet), with complications. Severe angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers. |
| diabetes_moderate_cohort | – | –Patients with type 1 diabetes and moderate microangiopathy. moderate non-proliferative retinopathy or proliferative retinopathy, macroalbuminuria or kidney failure (defined as estimated glomerular filtration rate <60 mL/min/1.73 m2 body surface) up to CKD-class 3A, and manifest neuropathy, (group c). |
| diabetes_mild_cohort | – | –Patient with mild microangiopathy, mild-moderate non-proliferative retinopathy and/or microalbuminuria and/or early signs of neuropathy (group b). |
| diabetes_none_cohort | – | –Patient with no microangiopathy, except for simplex or background retinopathy, which is in an early and reversible state (group a). |
| healthy_cohort | – | –Age- and sex- matched healthy controls, with no known increased risk of cardiovascular disease. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with type 1 diabetes will be recruited from the diabetes clinic at Danderyd Hospital, which currently follows around 1800 patients with type 1 diabetes. All patients matching the inclusion criteria will be asked to participate in the study by a doctor or nurse at their routine visit to the clinic. Responsible doctor or research nurse will also screen for suitable patients registered at the clinic, and call the patients that meet inclusion criteria to see if they would like to participate in the study after a short description of the study's purpose and setup. Recruitment of the control group will occur through digital advertisement, e.g. on the Karolinska Institute website.
Key inclusion criteria (9 listed)
- Severe type 1 diabetes (microangiopathy / diabetic feet), severe angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers.
- Age range: primarily 18-45 years, if not sufficient number of subjects can be found, then 18-60 years span is considered
- Phase 2: Scale of severity. In phase 2, patients are included with a broad range of severity levels. Patients with diabetes type 1 will be included.
- Age range: 18-45 years (younger patients are targeted for focus on microvascular complications, rather than age-related cardiovascular disease)
- Patient with no microangiopathy, except for simplex or background retinopathy, which is in an early and reversible state (group a), 100 patients.
Key exclusion criteria (5 listed)
- Patients unable to understand patient information due to cognitive impairment
- Patients unable to understand patient information due to language barriers
- Ongoing acute infection or inflammatory condition
- Pregnant or breastfeeding women
- Patients with damaged and/or scarred tissue in the areas of interest for the investigational or comparator devices
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
Correlation between investigational device-derived energy in endothelial band and endothelial pathology
Time frame: Same day as enrolment.
Correlation between SFDI- and laser speckle-derived endothelial energy band (perfusion, oxygenation) and blood marker indication of endothelial cell /glycocalyx deterioration and/or endothelial cell response from iontophoresis provocation.
Correlation between investigational device-derived energy in the myogenic band in the case of hypertension and myogenic related pathology
Time frame: Same day as enrolment.
Association between SFDI- and laser speckle-derived myogenic energy band and presence of hypertension, and/or indication of reduced smooth muscle cell response from iontophoresis provocation.
Correlation between investigational device-derived energy in the neurogenic band and indication of neuropathy
Time frame: Same day as enrolment.
Correlation between SFDI- and laser speckle-derived neurogenic energy band and indication/diagnosis of neuropathy, based on clinical assessment or electronic health records.
Correlation between investigational device-derived brachial post-occlusive hyperemia (PORH) peak oxygenation and degree of neuropathic angiopathy
Time frame: Same day as enrolment.
Correlation of investigational device-derived peak oxygen saturation amplitude from brachial PORH test against degree of microangiopathy/ microvascular complications.
Difference in response (perfusion) to mild local heat provocation between diabetes type 1 and healthy controls
Time frame: Same day as enrolment.
Difference in IMD-derived variables of perfusion between healthy controls and patients with diabetes type 1 during mild local heat provocation (~30ᵒC).
Difference in response (oxygenation) to mild local heat provocation between diabetes type 1 and healthy controls
Time frame: Same day as enrolment.
Difference in IMD-derived variables of oxygenation between healthy controls and patients with diabetes type 1 during mild local heat provocation (~30ᵒC).
Difference in response (hemoglobin concentration) to mild local heat provocation between diabetes type 1 and healthy controls
Time frame: Same day as enrolment.
Difference in IMD-derived variables of hemoglobin concentration between healthy controls and patients with diabetes type 1 during mild local heat provocation (~30ᵒC).
Difference in response (perfusion) to increased local heat provocation between diabetes type 1 and healthy controls
Time frame: Same day as enrolment.
Difference in IMD-derived variables of perfusion between healthy controls and patients with diabetes type 1 during increased local heat provocation (~35ᵒC).
Difference in response (oxygenation) to increased local heat provocation between diabetes type 1 and healthy controls
Time frame: Same day as enrolment.
Difference in IMD-derived variables of oxygenation between healthy controls and patients with diabetes type 1 during increased local heat provocation (~35ᵒC).
Difference in response (hemoglobin concentration) to increased local heat provocation between diabetes type 1 and healthy controls
Time frame: Same day as enrolment.
Difference in IMD-derived variables of hemoglobin concentration between healthy controls and patients with diabetes type 1 during increased local heat provocation (~35ᵒC).
Difference in response (perfusion) to high local heat provocation between diabetes type 1 and healthy controls
Time frame: Same day as enrolment.
Difference in IMD-derived variables of perfusion between healthy controls and patients with diabetes type 1 during high local heat provocation (~40-44ᵒC).
Difference in response (oxygenation) to high local heat provocation between diabetes type 1 and healthy controls
Time frame: Same day as enrolment.
Difference in IMD-derived variables of oxygenation between healthy controls and patients with diabetes type 1 during high local heat provocation (~40-44ᵒC).
4 secondary outcomes
Assessment of distribution of oxygenation in foot soles of patients with diabetic feet compared to healthy controls
Time frame: Same day as enrolment.
Assessment of distribution of perfusion in foot soles of patients with diabetic feet compared to healthy controls
Time frame: Same day as enrolment.
Assessment of if the addition of thermal provocation can increase contrasts between diabetic feet and feet of healthy controls
Time frame: Same day as enrolment.
Assessment of if the addition of investigational device-derived water concentration data can increase contrasts between diabetic feet and feet of healthy controls
Time frame: Same day as enrolment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Background: PubMed 34826433Jonasson H, Bergstrand S, Fredriksson I, Larsson M, Ostgren CJ, Stromberg T. Post-ischemic skin peak oxygen saturation is associated with cardiovascular risk factors: a Swedish cohort study. Microvasc Res. 2022 Mar;140:104284. doi: 10.1016/j.mvr.2021.104284. Epub 2021 Nov 23.
- Background: PubMed 33219118Murphy GA, Singh-Moon RP, Mazhar A, Cuccia DJ, Rowe VL, Armstrong DG. Quantifying dermal microcirculatory changes of neuropathic and neuroischemic diabetic foot ulcers using spatial frequency domain imaging: a shade of things to come? BMJ Open Diabetes Res Care. 2020 Nov;8(2):e001815. doi: 10.1136/bmjdrc-2020-001815.
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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.
Sarah Tehrani, MD, PhD principal investigator
Danderyd Hospital, Department of Internal Medicine, Stockholm, Sweden
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 Diabetes Type 1, run by HJN Sverige AB/Neko Health at 1 site in Sweden.
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 9 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 25 May 2025. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mattias Windå (+46703169040, mattias@nekohealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between investigational device-derived energy in endothelial band and endothelial pathology (time frame: Same day as enrolment.). The study lists 12 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 NCT06989190, which also lists 2 linked publications.
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 25 May 2025.