Diabetes MellitusNCT05597605
The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
A study testing The SHINE SYSTEM in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Indigo Diabetes NV at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- The SHINE SYSTEM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 21 Sep 2022to 23 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Ketoacidosis, Diabetic, Hyperglycaemia (Diabetic), Hypoglycemia
- Being tested
- The SHINE SYSTEM
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Ketoacidosis, Hyperglycemia, Hypoglycemia, GCM
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetic Ketoacidosis, Hyperglycemia, Hypoglycemia, Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The SHINE SYSTEMDevice
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
| Study group | Role | What they receive |
|---|---|---|
| The SHINE SYSTEM | Experimental | Not described Receives: Device: The SHINE SYSTEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months
Secondary outcomes (6)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start21 Sep 2022
- Primary completion19 Dec 2023
- Study completion23 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indigo Diabetes NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe De Block, Prof. Dr., Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597605
- Sponsor's protocol ID
- IND008
- Status last verified
- Mar 2024
- First submitted
- 19 Sep 2022
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05597605
- Acronym / sponsor ID
- IND008
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Indigo Diabetes NVIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 19 Dec 2023 (actual)
- Study completion
- 23 Jan 2024 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The SHINE SYSTEM | Experimental | Device: The SHINE SYSTEM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The SHINE SYSTEMThe 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 | Device | The SHINE SYSTEM |
Primary outcome
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
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
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
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
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
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 secondary outcomes
Secondary Safety Objectives: Confirm safe explantation of the SENSOR from human subcutaneous tissue (removal procedural safety)
Time frame: 30 days
Secondary Safety Objectives: Confirm general safety in the clinic and during home use (general safety)
Time frame: 6 months
Secondary Performance Objective: Assessment of procedural success for the implantation procedure
Time frame: 30 days
Secondary Performance Objective: Assessment of procedural success for the explantation procedure
Time frame: 30 days
Secondary Performance Objective: Assessment of procedural success for the implantation and explantation procedure
Time frame: 30 days
Secondary Performance Objective: Assessment of procedural success for the implantation and explantation procedure
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe De Block, Prof. Dr. principal investigator
University Hospital, Antwerp
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The SHINE SYSTEM in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Indigo Diabetes NV at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, France, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Objectives: Confirm safe implantation of the SENSOR in human subcutaneous tissue (insertion procedural safety) (time frame: 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.