- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05597605
The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
March 14, 2024 updated by: Indigo Diabetes NV
The SHINE Study: An Open Label, Interventional, Multicentre, Prospective Feasibility Study, Designed to Evaluate the Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Subjects willing to sign an informed consent form (ICF)
- Adult subjects, age ≥ 18
- Subjects willing to comply to study protocol requirements (study visits with frequent venous blood sampling and deliberate insulin, glucose, ketone and lactate (sub study only) challenges)
- Subjects willing to wear a Dexcom G6 CGM during duration of the study
- Subjects willing to charge the FUSHO SENSOR/ED and CHARGER on daily basis
- Patients with type 1 diabetes mellitus (T1DM) according to WHO criteria, diagnosed for at least 12 months prior to screening, on Multiple Daily Injections (MDI), not on insulin pump treatment during the course of the study
- Patients with type 2 diabetes mellitus (T2DM) on Intensive Insulin Therapy (IIT), with a minimum of four injections per day and known dosing parameters
Exclusion Criteria:
- Known allergy to PDMS
- Subjects with a contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, untreated hypothyroidism)
- History of severe hypoglycaemia in the previous 6 months. Severe hypoglycaemia is defined as hypoglycaemia resulting in loss of consciousness or seizure
- History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
- History of, hepatitis C or HIV or other disease transmissible by blood
- A condition requiring or likely to require magnetic resonance imaging (MRI) during the study duration
- Female subjects who are pregnant, planning on becoming pregnant or nursing
- Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor are allowed).
- Anemia identified by a haemoglobin <14 g/dL for men or <12 g/dL for women
- The presence of any other active implanted device
- The presence of any other CGM sensor or transmitter located in lower abdomen or back (other location is acceptable)
- Waist circumference of >120 cm
- Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: The SHINE SYSTEM
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Safety Objectives: Confirm safe implantation of the SENSOR in human subcutaneous tissue (insertion procedural safety)
Time Frame: 30 days
|
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)
Time Frame: 6 months
|
Assessment of device related adverse events during 6 months of implant use
|
6 months
|
Primary Initial Performance Objectives: Demonstration of SENSOR stability
Time Frame: 6 months
|
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
Time Frame: 6 months
|
(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
Time Frame: 6 months
|
(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.
Time Frame: 6 months
|
(c) Charging (charging efficiency) of the FUSHO SENSOR, as recorded on the APP
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Safety Objectives: Confirm safe explantation of the SENSOR from human subcutaneous tissue (removal procedural safety)
Time Frame: 30 days
|
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)
Time Frame: 6 months
|
|
6 months
|
Secondary Performance Objective: Assessment of procedural success for the implantation procedure
Time Frame: 30 days
|
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
Time Frame: 30 days
|
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
Time Frame: 30 days
|
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
Time Frame: 30 days
|
The primary initial performance endpoint at further timepoints through 30 days and 3 months
|
30 days
|
Other Outcome Measures
Outcome Measure |
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
Time Frame: 6 months
|
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
|
6 months
|
Exploratory Analysis: Accuracy of measurements for glucose demonstrated by Mean Absolute Relative Difference (MARD)
Time Frame: 6 months
|
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)
Time Frame: 6 months
|
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)
Time Frame: 6 months
|
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)
Time Frame: 6 months
|
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)
Time Frame: 6 months
|
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)
Time Frame: 6 months
|
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)
Time Frame: 6 months
|
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)
Time Frame: 6 months
|
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)
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Christophe De Block, Prof. Dr., University Hospital, Antwerp
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 21, 2022
Primary Completion (Actual)
December 19, 2023
Study Completion (Actual)
January 23, 2024
Study Registration Dates
First Submitted
September 19, 2022
First Submitted That Met QC Criteria
October 24, 2022
First Posted (Actual)
October 28, 2022
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 14, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IND008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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