Clinical trial NCT05597605: The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Ketoacidosis, Diabetic
Hyperglycaemia (Diabetic)
Hypoglycemia
Keywords: Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Ketoacidosis
Hyperglycemia
Hypoglycemia
GCM
Lead sponsor: Indigo Diabetes NV
Sponsor class: INDUSTRY
First posted: 2022-10-28
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Safety Objectives: Confirm safe implantation of the SENSOR in human subcutaneous tissue (insertion procedural safety)
timeFrame: 30 days
measure: Primary Safety Objectives: Confirm the safety of the device during the implantation period (safety of device integration in the subcutaneous tissue)
timeFrame: 6 months
measure: Primary Initial Performance Objectives: Demonstration of SENSOR stability
timeFrame: 6 months
measure: Primary Initial Performance Objectives: Confirm the ability to (a) retrieve spectral and metadata from the SENSOR and upload to the CLOUD
timeFrame: 6 months
measure: Primary Initial Performance Objectives: Confirm the ability to (b) show the battery and SENSOR-ED connectivity status to subject
timeFrame: 6 months
measure: Primary Initial Performance Objectives: Confirm the ability to (c) recharge the SENSOR, ED and CHARGER.
timeFrame: 6 months
Secondary outcomes:
measure: Secondary Safety Objectives: Confirm safe explantation of the SENSOR from human subcutaneous tissue (removal procedural safety)
timeFrame: 30 days
measure: Secondary Safety Objectives: Confirm general safety in the clinic and during home use (general safety)
timeFrame: 6 months
measure: Secondary Performance Objective: Assessment of procedural success for the implantation procedure
timeFrame: 30 days
measure: Secondary Performance Objective: Assessment of procedural success for the explantation procedure
timeFrame: 30 days
measure: Secondary Performance Objective: Assessment of procedural success for the implantation and explantation procedure
timeFrame: 30 days
measure: Secondary Performance Objective: Assessment of procedural success for the implantation and explantation procedure
timeFrame: 30 days
Other outcomes:
measure: 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
timeFrame: 6 months
measure: Exploratory Analysis: Accuracy of measurements for glucose demonstrated by Mean Absolute Relative Difference (MARD)
timeFrame: 6 months
measure: Exploratory Analysis: Accuracy of measurements for ketones demonstrated by Mean Absolute Relative Difference (MARD)
timeFrame: 6 months
measure: Exploratory Analysis: Accuracy of measurements for lactate demonstrated by Mean Absolute Relative Difference (MARD)
timeFrame: 6 months
measure: Exploratory Analysis: Accuracy of measurements for glucose demonstrated by Mean Absolute Deviation (MAD)
timeFrame: 6 months
measure: Exploratory Analysis: Accuracy of measurements for ketones demonstrated by Mean Absolute Deviation (MAD)
timeFrame: 6 months
measure: Exploratory Analysis: Accuracy of measurements for lactate demonstrated by Mean Absolute Deviation (MAD)
timeFrame: 6 months
measure: Exploratory Analysis: Accuracy of measurements for glucose demonstrated by Error Grid Analysis (EGA)
timeFrame: 6 months
measure: Exploratory Analysis: Accuracy of measurements for ketones demonstrated by Error Grid Analysis (EGA)
timeFrame: 6 months
measure: Exploratory Analysis: Accuracy of measurements for lactate demonstrated by Error Grid Analysis (EGA)
timeFrame: 6 months
measure: Exploratory Analysis: Histopathology analysis of the biopsy
timeFrame: 6 months
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Àntwerp
city: Montpellier
country: France
facility: Lapeyronie Montpellier University Hospital
city: Ljubljana
country: Slovenia
facility: University Medical Centre
Study officials:
affiliation: University Hospital, Antwerp
name: Christophe De Block, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: