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The objectives of SHINE study are to confirm the safety aspects of the SHINE SYSTEM. Moreover, the goal of this clinical investigation is the initial evaluation of sensor's performance by assessing sensor's ability to qualitatively detect the appropriate analytes in subjects with diabetes of 18 years and older.
Indigo Diabetes N.V. is currently developing an active implantable medical device, intended to be used for real time, continuous measurement of glucose and ketone levels in the interstitial fluid in adults (18 years and older) with diabetes mellitus. Based on the outcome of the GLOW Study, Indigo developed a prototype, the SHINE SYSTEM, that will be used during the planned clinical investigation (SHINE study).The objectives of SHINE study are to confirm the safety aspects of the SHINE system. Moreover, the goal of this clinical investigation is the initial evaluation of sensor's performance by assessing sensor's ability to qualitatively detect the appropriate analytes in subjects with diabetes of 18 years and older. Clinical performance of the device will not be formally evaluated during this clinical investigation. The study is designed to enable data collection (i.e., continuous collection of data by FUSHO sensor, implanted in study subject, combined with simultaneous collection of data collected by Dexcom G6), which will be used to develop the software algorithm in a future version of the device, in order to display measurements in real-time to the user.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The SHINE SYSTEM | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The SHINE SYSTEM | Device | The FUSHO sensor, which is part of the SHINE SYSTEM, is a continuous multi-metabolite monitoring (CMM) sensor which is a miniaturized near-infrared spectrometer that measures the absorption of light in the interstitial fluid to quantify the concentration of multiple metabolites |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Objectives: Confirm safe implantation of the SENSOR in human subcutaneous tissue (insertion procedural safety) | Incidence of FUSHO SENSOR insertion procedure-related serious adverse events within 30 days from implant | 30 days |
| Primary Safety Objectives: Confirm the safety of the device during the implantation period (safety of device integration in the subcutaneous tissue) | Assessment of device related adverse events during 6 months of implant use | 6 months |
| Primary Initial Performance Objectives: Demonstration of SENSOR stability | Demonstrate that device is able to provide a stable spectral signal and whether it is feasible to use these data points to create an algorithm. SENSOR Stability is defined by maintaining its spectral characteristics (availability, intensity and range) over its implantation duration of 6 months | 6 months |
| Primary Initial Performance Objectives: Confirm the ability to (a) retrieve spectral and metadata from the SENSOR and upload to the CLOUD | (a) Evaluation of the Bluetooth transmission: successful transmission of the spectral data from FUSHO SENSOR to the CLOUD via Bluetooth Low Energy (BLE). The proportion of data transmitted to the CLOUD versus the expected amount of data when device used as intended | 6 months |
| Primary Initial Performance Objectives: Confirm the ability to (b) show the battery and SENSOR-ED connectivity status to subject | (b) Display of battery and FUSHO SENSOR-ED connectivity status to subject | 6 months |
| Primary Initial Performance Objectives: Confirm the ability to (c) recharge the SENSOR, ED and CHARGER. |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Safety Objectives: Confirm safe explantation of the SENSOR from human subcutaneous tissue (removal procedural safety) | Incidence of FUSHO SENSOR removal-related serious adverse events within 30 days from explant | 30 days |
| Secondary Safety Objectives: Confirm general safety in the clinic and during home use (general safety) |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Analysis: Establishment of a model for evaluation of blood glucose, ketone and lactate values by the SENSOR by using the values obtained by other than SENSOR data | Development and refinement of a model that allows correct analysis of the spectral data read and translation into glucose, ketone and lactate (for sub-study only) values. The values will be analysed in conjunction with values obtained by comperative methods and used to further adjust this model. The model is expected to be able to demonstrate increased performance by subsequent iterations based on known absolute values. Iterations are expected to be performed until values are suitable for validation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe De Block, Prof. Dr. | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Àntwerp | Antwerp | 2650 | Belgium | |||
| Lapeyronie Montpellier University Hospital |
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|
(c) Charging (charging efficiency) of the FUSHO SENSOR, as recorded on the APP |
| 6 months |
|
| 6 months |
| Secondary Performance Objective: Assessment of procedural success for the implantation procedure | Successful FUSHO implantation (first implant in case of re-implant) procedure on average performed within 20 minutes (from incision to closure) without occurrence of procedure related SAEs | 30 days |
| Secondary Performance Objective: Assessment of procedural success for the explantation procedure | Successful FUSHO explantation procedure on average performed within 20 minutes (from incision to closure) without occurrence of procedure related SAEs | 30 days |
| Secondary Performance Objective: Assessment of procedural success for the implantation and explantation procedure | Procedural success defined as implantation of the FUSHO SENSOR within an average of 20 minutes (from start incision to closing of skin) without the occurrence of procedure related adverse events up to 30 days after implant | 30 days |
| Secondary Performance Objective: Assessment of procedural success for the implantation and explantation procedure | The primary initial performance endpoint at further timepoints through 30 days and 3 months | 30 days |
| 6 months |
| Exploratory Analysis: Accuracy of measurements for glucose demonstrated by Mean Absolute Relative Difference (MARD) | Post hoc analysis of accuracy of measurements for glucose demonstrated by Mean Absolute Relative Difference (MARD) intended for evaluation of the appropriateness of the algorithm/model for prediction of glucose. No health outcomes (e.g. ability to predict glycaemic values) are evaluated. | 6 months |
| Exploratory Analysis: Accuracy of measurements for ketones demonstrated by Mean Absolute Relative Difference (MARD) | Post hoc analysis of accuracy of measurements for glucose demonstrated by Mean Absolute Relative Difference (MARD) intended for evaluation of the appropriateness of the algorithm/model for prediction of ketones. No health outcomes (e.g. ability to predict glycaemic values) are evaluated. | 6 months |
| Exploratory Analysis: Accuracy of measurements for lactate demonstrated by Mean Absolute Relative Difference (MARD) | Post hoc analysis of accuracy of measurements for glucose demonstrated by Mean Absolute Relative Difference (MARD) intended for evaluation of the appropriateness of the algorithm/model for prediction of lactate. No health outcomes (e.g. ability to predict glycaemic values) are evaluated. | 6 months |
| Exploratory Analysis: Accuracy of measurements for glucose demonstrated by Mean Absolute Deviation (MAD) | Post hoc analysis of accuracy of measurements for glucose demonstrated by Mean Absolute Deviation (MAD) intended for evaluation of the appropriateness of the algorithm/model for prediction of glucose. No health outcomes (e.g. ability to predict glycaemic values) are evaluated. | 6 months |
| Exploratory Analysis: Accuracy of measurements for ketones demonstrated by Mean Absolute Deviation (MAD) | Post hoc analysis of accuracy of measurements for glucose demonstrated by Mean Absolute Deviation (MAD) intended for evaluation of the appropriateness of the algorithm/model for prediction of ketones. No health outcomes (e.g. ability to predict glycaemic values) are evaluated. | 6 months |
| Exploratory Analysis: Accuracy of measurements for lactate demonstrated by Mean Absolute Deviation (MAD) | Post hoc analysis of accuracy of measurements for glucose demonstrated by Mean Absolute Deviation (MAD) intended for evaluation of the appropriateness of the algorithm/model for prediction of lactate. No health outcomes (e.g. ability to predict glycaemic values) are evaluated. | 6 months |
| Exploratory Analysis: Accuracy of measurements for glucose demonstrated by Error Grid Analysis (EGA) | Post hoc analysis of accuracy of measurements for glucose demonstrated by Error Grid Analysis (EGA) intended for evaluation of the appropriateness of the algorithm/model for prediction of glucose. No health outcomes (e.g. ability to predict glycaemic values) are evaluated. | 6 months |
| Exploratory Analysis: Accuracy of measurements for ketones demonstrated by Error Grid Analysis (EGA) | Post hoc analysis of accuracy of measurements for glucose demonstrated by Error Grid Analysis (EGA) intended for evaluation of the appropriateness of the algorithm/model for prediction of ketones. No health outcomes (e.g. ability to predict glycaemic values) are evaluated | 6 months |
| Exploratory Analysis: Accuracy of measurements for lactate demonstrated by Error Grid Analysis (EGA) | Post hoc analysis of accuracy of measurements for glucose demonstrated by Error Grid Analysis (EGA) intended for evaluation of the appropriateness of the algorithm/model for prediction of lactate. No health outcomes (e.g. ability to predict glycaemic values) are evaluated | 6 months |
| Exploratory Analysis: Histopathology analysis of the biopsy | Histopathology analysis of the biopsy at explant on macroscopic and microscopic level, with Haematoxylin-Eosin (HE) staining, to assess potential changes of surrounding cells and tissue around the sensor and local tissue tolerance/interaction by investigating local tissue inflammation (fibrosis, foreign body reaction (e.g. presence of giant cells, macrophages and other)) | 6 months |
| Montpellier |
| France |
| University Medical Centre | Ljubljana | Slovenia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D016883 | Diabetic Ketoacidosis |
| D006943 | Hyperglycemia |
| D007003 | Hypoglycemia |
| D007662 | Ketosis |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D048909 | Diabetes Complications |
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