MicroangiopathyMINDNCT07145567
Microangiopathy in Diabetes
An observational study of Microangiopathy and Microvascular Complications, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This clinical trial aims to evaluate the use of a contactless and non-invasive technique to measure the properties of the skin's microcirculation and its regulatory functions in both healthy individuals and patients with microvascular disease associated with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Microangiopathy, Microvascular Complications
- How many people
- 400 participants
- Where
- 1 siteSweden
- Study dates
- 1 Mar 2024to Dec 2027
- 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: Outpatient at Danderyd Hospital Diabetes Clinic
Who may be able to join
- Diabetes mellitus type 1.
- Cohort specific inclusion criteria apply, please review 'groups' section.
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 disease or inflammatory condition.
- Pregnant or breast-feeding 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
Danderyd University Hospital
Danderyd, Stockholm County, 182 88
Sara Tehrani, Medical Doctor, +460812355000, sara.tehrani@ki.se
Jacob Widaeus, Medical Doctor, +460812359601, jacob.widaeus@ki.se
About this study
Official title: Microangiopathy IN Diabetes
This clinical trial aims to evaluate the use of a contactless and non-invasive technique to measure the properties of the skin's microcirculation and its regulatory functions in both healthy individuals and patients with microvascular disease associated with type 1 diabetes. It is hoped that the study results will lead to the development of a useful method for detecting diabetic complications at an early stage, thereby enabling treatment and preventive measures before the onset of severe microangiopathy.
Read the detailed description
This study will employ investigational devices to evaluate microvascular function and correlate it to degree of microangiopathy in persons with diabetes type 1 and healthy controls.
The investigational device, TCI P4, is a novel, contactless, non-invasive, non-CE marked, class IIa Spatial Frequency Domain Imaging (SFDI) system. The device utilizes an LED light projector to cast patterned, multi-wavelength light onto the skin while multiple cameras capture narrow-band reflections. This method yields two-dimensional data on skin structure and molecular composition (including hemoglobin, oxygen, and water). Established comparators such as laser speckle contrast imaging (LSCI) and the EPOS system are employed to benchmark device performance and validate measurements.
- Conditions
- Microangiopathy, Microvascular Complications
- Keywords
- Laser speckle contrast imaging, Spatial frequency domain imaging, Laser doppler flowmetry, Iontophoresis, Local thermal hyperemia, Post occlusive reactive hyperemia
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 |
|---|---|---|
| Severe diabetic microangiopathy | Severe micro-angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers. Aged 18-60 years old. | |
| Moderate diabetic 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, and manifest neuropathy. Aged 18-45 years old. | |
| Mild diabetic microangiopathy | Mild-moderate non-proliferative retinopathy and/or microalbuminuria and/or early signs of neuropathy. Aged 18-45 years old. | |
| No diabetic microangiopathy | No microangiopathic complications, except for simplex or background retinopathy, which is an early and reversible state. Aged 18-45 years old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak perfusion in response to local thermal hyperemia
As measured with investigational devices TCI P4, Pericam LSCI and EPOS devices.
Measured: Investigation will take within 1 day from enrollment.
Secondary outcomes (1)
Perfusion heterogeneity in sole of feet
Perfusion heterogeneity index as measured by investigational device TCI P4. It will be stated as a numerical ordinal scale.
Measured: Investigation will take place within 1 day from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Mar 2024
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicroangiopathyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Neko Health AB
- Responsible party
- Principal investigator, Sara Tehrani, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145567
- Sponsor's protocol ID
- 2023-02232-01
- Other IDs
- 2023
- Acronym
- MIND
- Status last verified
- Feb 2025
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microangiopathy IN Diabetes
- ClinicalTrials.gov ID
- NCT07145567
- Acronym / sponsor ID
- MIND / 2023-02232-01
- Conditions
- Microangiopathy, Microvascular Complications
- Keywords
- Laser speckle contrast imaging, Spatial frequency domain imaging, Laser doppler flowmetry, Iontophoresis, Local thermal hyperemia, Post occlusive reactive hyperemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Neko Health AB
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Aug 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 trial aims to evaluate the use of a contactless and non-invasive technique to measure the properties of the skin's microcirculation and its regulatory functions in both healthy individuals and patients with microvascular disease associated with type 1 diabetes. It is hoped that the study results will lead to the development of a useful method for detecting diabetic complications at an early stage, thereby enabling treatment and preventive measures before the onset of severe microangiopathy.
Detailed description
This study will employ investigational devices to evaluate microvascular function and correlate it to degree of microangiopathy in persons with diabetes type 1 and healthy controls.
The investigational device, TCI P4, is a novel, contactless, non-invasive, non-CE marked, class IIa Spatial Frequency Domain Imaging (SFDI) system. The device utilizes an LED light projector to cast patterned, multi-wavelength light onto the skin while multiple cameras capture narrow-band reflections. This method yields two-dimensional data on skin structure and molecular composition (including hemoglobin, oxygen, and water). Established comparators such as laser speckle contrast imaging (LSCI) and the EPOS system are employed to benchmark device performance and validate measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Severe diabetic microangiopathy | – | –Severe micro-angiopathy defined as proliferative retinopathy, macroalbuminuria, and kidney failure with at least CKD-class 3B and severe neuropathy with or without foot ulcers. Aged 18-60 years old. |
| Moderate diabetic 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, and manifest neuropathy. Aged 18-45 years old. |
| Mild diabetic microangiopathy | – | –Mild-moderate non-proliferative retinopathy and/or microalbuminuria and/or early signs of neuropathy. Aged 18-45 years old. |
| No diabetic microangiopathy | – | –No microangiopathic complications, except for simplex or background retinopathy, which is an early and reversible state. Aged 18-45 years old. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Outpatient at Danderyd Hospital Diabetes Clinic
Key inclusion criteria (2 listed)
- Diabetes mellitus type 1.
- Cohort specific inclusion criteria apply, please review 'groups' section.
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 disease or inflammatory condition.
- Pregnant or breast-feeding 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
Peak perfusion in response to local thermal hyperemia
Time frame: Investigation will take within 1 day from enrollment.
As measured with investigational devices TCI P4, Pericam LSCI and EPOS devices.
1 secondary outcome
Perfusion heterogeneity in sole of feet
Time frame: Investigation will take place within 1 day from enrollment.
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 28 Aug 2025.
- Individual participant dataSharing planned: No
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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.
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 Microangiopathy and Microvascular Complications, run by Karolinska Institutet 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 2 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 28 Aug 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 Sara Tehrani, Medical Doctor (+46 08 123 550 00, sara.tehrani@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak perfusion in response to local thermal hyperemia (time frame: Investigation will take within 1 day from enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2025.