The MIND Study - Microangiopathy IN Diabetes
ConditionDiabetes Type 1
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorHJN Sverige AB/Neko Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
400 Participants
are grouped into 5 trial groupsGroup A: diabetes_severe_cohort
Group B: diabetes_moderate_cohort
Group C: diabetes_mild_cohort
Group D: diabetes_none_cohort
Group E: healthy_cohort
Trial outcomes
Primary outcomes
1
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.
Time frame
Same day as enrolment.2
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.
Time frame
Same day as enrolment.3
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.
Time frame
Same day as enrolment.4
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.
Time frame
Same day as enrolment.Secondary outcomes
1
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.
Time frame
Same day as enrolment.2
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.
Time frame
Same day as enrolment.3
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.
Time frame
Same day as enrolment.4
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.
Time frame
Same day as enrolment.Sponsors and contacts
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Source ClinicalTrials.gov