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Failed to recruit sufficient subjects
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This study collected spectral raman data from diabetic patients. Data was paired with validated capillary references as well as CGM/FGM readings. Data was used to develop models for glucose prediction.
This trial constitutes three subprotocols: "The OUH protocol", "The Home 1 protocol" and "The Home 2 protocol" The investigation was initiated to collect spectral raman data paired with validated blood references. In the OUH protocol, capillary blood was analysed by ABL 800 Flex blood gas analyzer by Radiometer. In the Home 1 protocol, references were obtained by the finger pricking procedure from HemoCue (Radiometer). In the Home 2 protocol, HemoCue measurements were conducted along with continuous monitoring using Dexcom G4/G5 device (Dexcom) or FreeStyle Libre (Abbott) The data was collected from diabetic patients and Optical Coherence Tomography (OCT) readings were obtained from all subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OUH protocol | Experimental | The protocol constituted two outpatient visits in the clinic within one week. Each visit had a duration of approximately 2,5 hours. Prior to study, optical screenings were conducted:
Subjects were measured by the following scheme: ABL measurement, two optical measurements on WM3.4 #1 followed by two optical measurements on WM3.4 #2. |
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| Home 1 protocol | Experimental | Optical screening (OCT and device) was conducted at baseline visit in the Department of Endocrinology M at Odense University Hospital. WM3.4 was subsequently delivered to subject's home and the subject measured 30 days in a 60 days period of time. HemoCue was used for reference. |
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| Home 2 protocol | Experimental | Optical screening (OCT and device) was conducted at baseline visit in the Department of Endocrinology M at Odense University Hospital. WM3.4 was subsequently delivered to subject's home and the subject measured 30 days in a 60 days period of time. HemoCue and CGM/FGM was used for reference. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WM3.4 | Device | Investigational Medical Device collecting spectral raman data from tissue. |
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| Measure | Description | Time Frame |
|---|---|---|
| Calibration models for device predictive purposes | Spectral raman data paired with validated references used to develop predictive algorithms with glucose prediction capablities. The preformance was validated using the consensus error grid. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Erik Henriksen, MD | Odense University Hospital, Dpt. of Endocrinology M | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Endocrinology M, Odense University Hospital | Odense | 5000 | Denmark |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Open, non-randomized comparison study between device and blood references with diabetic patients
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