The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects

NCT05597605 | Completed

• 1 other identifier: IND008
• Study Type: interventional
• Target: 6
• Locations: 3 countries
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (6)

• 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.

  (c) Charging (charging efficiency) of the FUSHO SENSOR, as recorded on the APP

  6 months

Secondary Outcomes (6)

• Secondary Safety Objectives: Confirm safe explantation of the SENSOR from human subcutaneous tissue (removal procedural safety)

  30 days

• Secondary Safety Objectives: Confirm general safety in the clinic and during home use (general safety)

  6 months

• Secondary Performance Objective: Assessment of procedural success for the implantation procedure

  30 days

• Secondary Performance Objective: Assessment of procedural success for the explantation procedure

  30 days

• Secondary Performance Objective: Assessment of procedural success for the implantation and explantation procedure

  30 days

Other Outcomes (11)

• 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

  6 months

• Exploratory Analysis: Accuracy of measurements for glucose demonstrated by Mean Absolute Relative Difference (MARD)

  6 months

• Exploratory Analysis: Accuracy of measurements for ketones demonstrated by Mean Absolute Relative Difference (MARD)

  6 months

Study Arms (1)

The SHINE SYSTEM

EXPERIMENTAL

Device: The SHINE SYSTEM

Interventions

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

The SHINE SYSTEM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indigo Diabetes NV: lead

Study Sites (3)

University Hospital Àntwerp

Antwerp, 2650, Belgium

Location

Lapeyronie Montpellier University Hospital

Montpellier, France

Location

University Medical Centre

Ljubljana, Slovenia

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Ketoacidosis; Hyperglycemia; Hypoglycemia; Ketosis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Acidosis; Acid-Base Imbalance; Diabetes Complications

Study Officials

• Christophe De Block, Prof. Dr.

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: October 28, 2022
• Study Start: September 21, 2022
• Primary Completion: December 19, 2023
• Study Completion: January 23, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

SL (1); BE (1); FR (1)