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This clinical study has been launched to collect spectral Raman data on the Investigational Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples and capillary and venous references.
Subjects will visit the clinic for a baseline visit and two in-clinic visits. On in-clinic days, subjects will attend the clinic in a fasting state. They will have inserted a Dexcom and Freestyle Libre and a microdialysis catheter. At time = 0, subjects will be administered a glucose rich drink and every 6. minut measurements will be performed. These include a measurement on the IMD, microdialysate, FreeStyle Libre and Dexcom readings. Every 18. minut a venous blood sample will be included and every 36. minut a capillary blood sample will be collected. This continues until time = 180 minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RSP-08 | Experimental | All subjects undergo the same procedures. Subjects will be subjected to measurements on the IMD (Working Model 3.4NR), FreeStyle Libre, Dexcom, microdialysis, venous and capillary blood collection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Working Model 3.4NR | Device | Investigational Medical Device collecting spectral Raman data from tissue |
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| Measure | Description | Time Frame |
|---|---|---|
| Generation and validation of prediction models - MARD | Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Mean Absolute Relative Difference (MARD) endpoint measure. | One year |
| Generation and validation of prediction models - ISUP | Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Inter Subject Unified Performance (ISUP) measure. | One year |
| Generation and validation of prediction models - Consensus Error Grid | Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. Collected data will be used to generate individual calibration models capable of predicting tissue glucose. Models will be validated on independent data sets using Consensus Error Grid Analysis | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of dynamics between arterial and venous glucose profiles in relation to interstitial glucose levels | Two in-clinic visits each of a duration of 5-6 hours are scheduled for each subject. Subjects will enter clinic in fasting state and will receive an oral glucose bolus. Glucose excursion is followed with frequent capillary and venous blood samples along with FGM and CGM readings and microdialysis. In parallel, optical glucose data from the investigational medical device will be collected. Optical glucose readings will be masked to the subjects. A modeling-based evaluation of the dynamics between blood glucose and tissue glucose will be conducted and serve as a secondary endpoint of the study. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per-Anders Jansson, MD | Sahlgrenska Universitetssjukhuset, Gothenburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gothia Forum för Klinisk Forskning, Sahlgrenska Universitetssjukhuset | Gothenburg | Sweden |
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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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| One year |
| Safety evaluation: paucity of adverse events | Safety will be evaluated in a descriptive manner by the paucity of adverse events | One year |