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| Name | Class |
|---|---|
| Aalborg University | OTHER |
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MEDON aims to examine new methods for early detection and grading of diabetic peripheral neuropathy focusing on both small- and large nerve fibers. Furthermore, MEDON aims to describe differences between people with classic diabetic peripheral neuropathy and those with painful diabetic neuropathy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 1 diabetes and painful neuropathy | No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied. |
| |
| Type 1 diabetes and non-painful neuropathy | No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied. |
| |
| Type 1 diabetes and no neuropathy | No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perception Threshold Tracking (PTT) | Diagnostic Test | low-current electrical stimulation of both large- and small nerve fibers. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic value of CCM, PTT, AF and MRI | Using Quantitative Sensory Testing (small fibers) and conventional nerve conduction studies (large fibers) as golden standards, we will determine the prognostic value of: Perception Threshold Tracking Corneal Confocal Microscopy Axon-flair mediated response MRI-scans in detecting neuropathy. Sensitivity and specificity will be reported. OBS! Tests will be tested in the initial groups and AFTER a group re-arrangement based on results from QST and NCS. | End of study (when all patients have completed all sessions. Latest 31. december 2021) |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of PainDETECT in diabetes | Correlation between PainDETECT and DN4 will be reported. | End of study / end of inclusion (when all patients have completed the screening session. Latest 31. november 2021) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory measures | An multi-variant analysis to determine the predictive ability of combinations of primary outcome measures. | End of study (latest december 31 2021). |
Inclusion Criteria:
Exclusion Criteria:
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The study population include four well-defined groups of subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Niels Ejskjær, Professor | Steno Diabtes Center North Denmark, Aalborg University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | North Denmark | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41246983 | Derived | Moussa F, Taleb S, Borbjerg MK, Croosu SS, Morch CD, Frokjaer JB, Hansen TM, Ejskjaer N, Roikjer J. Corneal Immune Cells and Their Relation to Diabetic Peripheral Neuropathy and Neuropathic Pain. Muscle Nerve. 2026 Jan;73(1):72-78. doi: 10.1002/mus.70061. Epub 2025 Nov 17. | |
| 40987057 | Derived | Hostrup SN, Lind HP, Croosu SS, Roikjer J, Morch CD, Ejskjaer N, Ostergaard LR, Hansen TM, Frokjaer JB. Multimodal MRI analysis selecting key brain features for machine learning based classification of diabetic neuropathic pain and phenotypes. J Neurol Sci. 2025 Nov 15;478:123701. doi: 10.1016/j.jns.2025.123701. Epub 2025 Sep 15. |
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Data will be shared with collaborating department: Department of Radiology with the purpose of analyzing the data and comparing it to their MRI scans.
Data will be shared with Aalborg University with the purpose of analyzing data.
During and after the study. Data will be available no longer than needed for analyzing.
anonymized data
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2019 |
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| Matched controls without diabetes | No interventions. A series of observationel/expirimental methods for detecting and grading neuropathy will be applied. |
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| Axon-flair mediated respons | Diagnostic Test | Laser-doppler examination of small blood vessels in the peripheral skin. |
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| Heart rate variability | Diagnostic Test | 4 measurements of heart rate. |
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| Quantitative Sensory Testing (QST) | Diagnostic Test | Seven tests measuring 13 parameters including heat- and cold-detection and pain thresholds, mechanical pain treshold, mechanical detection threshold, pressure pain treshold and vibration threshold. |
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| Peripheral blood pressure and transcutaneous oxygen tension | Diagnostic Test | Ankle/brachial index, toe/brachial index, TcpO2. |
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| Magnetic Resonance Imaging (MRI) | Diagnostic Test | MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI. |
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| Questionnaires | Diagnostic Test | Questionnaires for detecting painful neuropathy |
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| Corneal Confocal Microscopy /CCM) | Diagnostic Test | Confocal microscopy of the cornea measuring NBD, NFD, NFL |
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| 36825610 | Derived | Roikjer J, Croosu SS, Sejergaard BF, Hansen TM, Frokjaer JB, Sondergaard CB, Petropoulos IN, Malik RA, Nielsen E, Morch CD, Ejskjaer N. Diagnostic Accuracy of Perception Threshold Tracking in the Detection of Small Fiber Damage in Type 1 Diabetes. J Diabetes Sci Technol. 2024 Sep;18(5):1157-1164. doi: 10.1177/19322968231157431. Epub 2023 Feb 24. |
| 36130086 | Derived | Roikjer J, Croosu SS, Frokjaer JB, Hansen TM, Arendt-Nielsen L, Ejskjaer N, Morch CD. Perception threshold tracking: validating a novel method for assessing function of large and small sensory nerve fibers in diabetic peripheral neuropathy with and without pain. Pain. 2023 Apr 1;164(4):886-894. doi: 10.1097/j.pain.0000000000002780. Epub 2022 Sep 19. |
| Aug 30, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003929 | Diabetic Neuropathies |
| C564945 | Neuropathy, Painful |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017078 | Laser-Doppler Flowmetry |
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012212 | Rheology |
| D008919 | Investigative Techniques |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
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