NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes
This study has been completed.
Sponsor:
Lise Tarnow
Information provided by (Responsible Party):
Lise Tarnow, Steno Diabetes Center
ClinicalTrials.gov Identifier:
NCT01707979
First received: September 25, 2012
Last updated: October 15, 2012
Last verified: October 2012
| Tracking Information | |||||
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| First Received Date ICMJE | September 25, 2012 | ||||
| Last Updated Date | October 15, 2012 | ||||
| Start Date ICMJE | September 2012 | ||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
near infrared spectroscopy [ Time Frame: one time ] [ Designated as safety issue: No ] Near infrared (NIR) is measured by spectroscopy on the skin using the DDD probe |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01707979 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | NIR- and Multifrequent Impedance Spectroscopy on the Skin in Type 1 Diabetes | ||||
| Official Title ICMJE | NIR (Near Infrared)- Spectroscopy and Multifrequent Impedance Spectroscopy on the Skin to Detection of Sensory and Autonomic Neuropathy Among Patients With Type 1 Diabetes | ||||
| Brief Summary | The aim of the study is to examine the suitability to detect diabetic neuropathy using NIR and impedance. |
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| Detailed Description | The aim of the study is to examine how suitable a hand-held measuring probe (DDD-probe) using NIR (near infrared light) as well as impedance (conductivity), is to detect early signs of diabetic neuropathy. The DDD-probe is put directly on the skin and is measuring by the use of light and impedance. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Control group men without diabetes Type1 diabetic men without neuropathy complications Type 1 diabetic men with neuropathy complications |
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| Condition ICMJE | Diabetic Neuropathy | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | October 2012 | ||||
| Primary Completion Date | October 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 35 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01707979 | ||||
| Other Study ID Numbers ICMJE | NIR | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Lise Tarnow, Steno Diabetes Center | ||||
| Study Sponsor ICMJE | Lise Tarnow | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Steno Diabetes Center | ||||
| Verification Date | October 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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