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The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects 6

Completed
Clinical Trial NCT05597605 was an interventional study for Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Ketoacidosis, Diabetic, Hyperglycaemia (Diabetic), Hypoglycemia that is now completed. The study started on 21 September 2022, with plans to enroll 6 participants. Led by Indigo Diabetes NV, the expected completion date was 23 January 2024. The latest data from ClinicalTrials.gov was last updated on 15 March 2024.
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 obj...Show More
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

Conditions
Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Ketoacidosis, DiabeticHyperglycaemia (Diabetic)Hypoglycemia
Other Study IDs
  • IND008
NCT ID Number
NCT05597605
Start Date (Actual)
2022-09-21
Last Update Posted
2024-03-15
Completion Date (Estimated)
2024-01-23
Enrollment (Estimated)
6
Study Type
Interventional
PHASE
N/A
Status
Completed
Keywords
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Ketoacidosis
Hyperglycemia
Hypoglycemia
GCM
Primary Purpose
Device Feasibility
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalThe SHINE SYSTEM
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
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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.
(c) Charging (charging efficiency) of the FUSHO SENSOR, as recorded on the APP
6 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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)
* All Serious Adverse Events collected throughout the study and reported at 30 days, 3 months and 6 months * Assessment of device related adverse events at 30 days, 3 and 6 months * Wound status at each visit. Final result on healing just at explant.
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
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • 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.
Indigo Diabetes NV logoIndigo Diabetes NV
No contact data.
3 Study Locations in 3 Countries
University Hospital Àntwerp, Antwerp, 2650, Belgium
Lapeyronie Montpellier University Hospital, Montpellier, France
University Medical Centre, Ljubljana, Slovenia