Diabetes MellitusNCT04782934
The GLOW Study - The YANG System
A study testing The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement in people with Diabetes Mellitus and Glucose, run by Indigo Diabetes NV at 1 site in Belgium.
Trial summary
This is an open label, interventional, monocentric, prospective early feasibility study, designed to evaluate the safety of implant and short-term integration into the tissue of the YANG sensor. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Glucose
- What is being tested?
- The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Feb 2021to 19 Jun 2021
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- T1DM patients
- Subjects willing to sign an informed consent form (ICF),
- Adult subjects, age ≥ 18, ≤ 50 years old
- Body Mass Index (BMI) 20≥, ≤ 27.5 [kg/m2]
- Subjects willing to comply to study protocol requirements (exercises, ketone ester drinks, alcohol, study visits, blood sampling etc)
- Patients with type 1 diabetes mellitus (T1DM) according to WHO criteria, diagnosed for at least 12 months prior to screening
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- Subjects being on insulin pump for at least 12 months
- Healthy Volunteers
- Subjects willing to sign an informed consent form (ICF),
- Adult subjects, age ≥ 18, ≤ 50 years old
- BMI 20≥, ≤ 27.5
- Subjects willing to comply to study protocol requirements (exercises, ketone ester drinks, alcohol, study visits, blood sampling etc)
- Healthy subjects, as self-declared and confirmed by screening assessments and Principal Investigator's judgment
Who cannot join
- Subjects with a contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, hypothyroidism, known allergic reaction to ibuprofen/paracetamol/acetylsalicylic acid)
- For people with diabetes: History of severe hypoglycaemia in the previous 6 months. Severe hypoglycaemia is defined as hypoglycaemia resulting in loss of consciousness or seizure
- For people with diabetes: History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
- Any blood disorder identified by haematocrit <30% or >55%
- History of hepatitis B, hepatitis C, or HIV
- 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
- Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
- Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication
- Any long-term drug treatments other than insulin, such as statins, low-dose aspirin, fibrates etc.
- The presence of any other active implanted device except for insulin pumps (as defined further in protocol)
- The presence of any other CGM sensor or transmitter located in abdomen (other location is acceptable)
- Impaired fasting glucose or impaired glucose tolerance (for healthy volunteers)
- Any contraindication to the use of the Yang system as listed in the device IFU (i.e. any known allergy to PDMS)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Feasibility and First in Human Study of the YANG System for Continuous Monitoring of Glucose, Ketones and Lactate - The GLOW Study
This is an open label, interventional, monocentric, prospective early feasibility study, designed to evaluate the safety of implant and short-term integration into the tissue of the YANG sensor. In addition, the set up will enable data collection which will be used to develop the software algorithm to allow real-time, continuous measurement of glucose, ketone and lactate levels in the interstitial fluid in adults with diabetes mellitus, in a future version of the device.
- Conditions
- Diabetes Mellitus, Glucose
- Being tested
- The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone MeasurementDevice
The YANG SENSOR is an active implantable device, that is intended to be implanted in the subcutaneous abdominal tissue, approximately 10mm below the skin. The SENSOR is battery powered. The battery is wirelessly recharged through the skin by the YANGEXD, using a charging coil ('Donut') applied to the skin with an adhesive patch at the level of the SENSOR. The 'Donut' also receives data from the sensor.
| Study group | Role | What they receive |
|---|---|---|
| YANG system group | Experimental | Not described Receives: Device: The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device-related or sensor insertion/removal procedure-related adverse events
Measured: 57 days
Assessment of foreign body reaction due subcutaneous implantation with biopsy
Assessment of i.e. inflammation, infection, tissue vascularization, formation of fibrotic scar tissue
Measured: 27 days
Incidence of sensor failure
Measured: 27 days
Secondary outcomes (3)
Collection of users feedback in the form of clinical questionnaire to assess the 'easiness' of surgical procedure with questionnaire
Measured: 1 day
Requirements of duration of implantation and explantation procedure
Measured: 27 days
Post explantation follow-up
Removal of sutures and wound healing after 10 days post explantation of the sensor. Follow-up via phone call after 30 days
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 posted4 Mar 2021
- Study start25 Feb 2021
- Primary completion19 Jun 2021
- Study completion19 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indigo Diabetes NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Sponsor
- Investigators
- Christophe De Block, Prof. Dr., Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782934
- Sponsor's protocol ID
- IND007
- Status last verified
- Mar 2021
- First submitted
- 24 Feb 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Ridder F, Braspenning R, Ordonez JS, Klarenbeek G, Lauwers P, Ledeganck KJ, Delbeke D, De Block C. Early feasibility study with an implantable near-infrared spectroscopy sensor for glucose, ketones, lactate and ethanol. PLoS One. 2024 May 3;19(5):e0301041. doi: 10.1371/journal.pone.0301041. eCollection 2024.
PubMed 38701088
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility and First in Human Study of the YANG System for Continuous Monitoring of Glucose, Ketones and Lactate - The GLOW Study
- ClinicalTrials.gov ID
- NCT04782934
- Acronym / sponsor ID
- IND007
- Conditions
- Diabetes Mellitus, Glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Indigo Diabetes NVIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Antwerp
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 19 Jun 2021 (actual)
- Study completion
- 19 Jun 2021 (actual)
- First posted
- 4 Mar 2021 (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.
This is an open label, interventional, monocentric, prospective early feasibility study, designed to evaluate the safety of implant and short-term integration into the tissue of the YANG sensor. In addition, the set up will enable data collection which will be used to develop the software algorithm to allow real-time, continuous measurement of glucose, ketone and lactate levels in the interstitial fluid in adults with diabetes mellitus, in a future version of the device.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YANG system group | Experimental | Device: The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- T1DM patients
- Subjects willing to sign an informed consent form (ICF),
- Adult subjects, age ≥ 18, ≤ 50 years old
- Body Mass Index (BMI) 20≥, ≤ 27.5 [kg/m2]
- Subjects willing to comply to study protocol requirements (exercises, ketone ester drinks, alcohol, study visits, blood sampling etc)
Key exclusion criteria (14 listed)
- Subjects with a contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, hypothyroidism, known allergic reaction to ibuprofen/paracetamol/acetylsalicylic acid)
- For people with diabetes: History of severe hypoglycaemia in the previous 6 months. Severe hypoglycaemia is defined as hypoglycaemia resulting in loss of consciousness or seizure
- For people with diabetes: History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
- Any blood disorder identified by haematocrit <30% or >55%
- History of hepatitis B, hepatitis C, or HIV
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 YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone MeasurementThe YANG SENSOR is an active implantable device, that is intended to be implanted in the subcutaneous abdominal tissue, approximately 10mm below the skin. The SENSOR is battery powered. The battery is wirelessly recharged through the skin by the YANGEXD, using a charging coil ('Donut') applied to the skin with an adhesive patch at the level of the SENSOR. The 'Donut' also receives data from the sensor. | Device | YANG system group |
Primary outcome
Incidence of device-related or sensor insertion/removal procedure-related adverse events
Time frame: 57 days
Assessment of foreign body reaction due subcutaneous implantation with biopsy
Time frame: 27 days
Assessment of i.e. inflammation, infection, tissue vascularization, formation of fibrotic scar tissue
Incidence of sensor failure
Time frame: 27 days
3 secondary outcomes
Collection of users feedback in the form of clinical questionnaire to assess the 'easiness' of surgical procedure with questionnaire
Time frame: 1 day
Requirements of duration of implantation and explantation procedure
Time frame: 27 days
Post explantation follow-up
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 21 Sep 2021.
- Derived from this study: PubMed 38701088De Ridder F, Braspenning R, Ordonez JS, Klarenbeek G, Lauwers P, Ledeganck KJ, Delbeke D, De Block C. Early feasibility study with an implantable near-infrared spectroscopy sensor for glucose, ketones, lactate and ethanol. PLoS One. 2024 May 3;19(5):e0301041. doi: 10.1371/journal.pone.0301041. eCollection 2024.
- Individual participant dataSharing planned: No
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement in people with Diabetes Mellitus and Glucose, run by Indigo Diabetes NV at 1 site in Belgium.
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 13 inclusion and 14 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 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
Incidence of device-related or sensor insertion/removal procedure-related adverse events (time frame: 57 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04782934, which also lists 1 linked publication.
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 21 Sep 2021.