The MIND Study - Microangiopathy IN Diabetes

NCT06989190 | Recruiting

• 1 other identifier: CIV-23-02-042193
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Type 1

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  Same day as enrolment.

Secondary Outcomes (4)

• Assessment of distribution of oxygenation in foot soles of patients with diabetic feet compared to healthy controls

  Same day as enrolment.

• Assessment of distribution of perfusion in foot soles of patients with diabetic feet compared to healthy controls

  Same day as enrolment.

• Assessment of if the addition of thermal provocation can increase contrasts between diabetic feet and feet of healthy controls

  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

  Same day as enrolment.

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HJN Sverige AB/Neko Health: lead

Study Sites (1)

VO Medicinska Specialiteter, Danderyd Hospital

Stockholm, 182 88, Sweden

RECRUITING

Related Publications (2)

• 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.

  PMID: 34826433 BACKGROUND

• Murphy 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.

  PMID: 33219118 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

A total of 30 ml och blood/plasma is saved for each study subject for later research analyses. Research blood samples are saved as whole blood or centrifuged directly at the Danderyd Department of Clinical Sciences laboratory, and is saved in smaller aliquotes (á 205 or 500 uL) which are marked with the study subject's pseudonymised participant ID/code number. Samples are kept in a -80 °C freezer at Danderyd Hospital under Stockholms Medicinska Biobank (SMD, reg nr 914) with Stockholm Municipality as the responsible party.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sarah Tehrani, MD, PhD

  Danderyd Hospital, Department of Internal Medicine, Stockholm, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mattias Windå

CONTACT

+46703169040; mattias@nekohealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 25, 2025
• Study Start: December 19, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

SE (1)