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The GLOW Study - The YANG System

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ClinicalTrials.gov Identifier: NCT04782934
Recruitment Status : Completed
First Posted : March 4, 2021
Last Update Posted : September 21, 2021
Sponsor:
Collaborator:
University Hospital, Antwerp
Information provided by (Responsible Party):
Indigo Diabetes NV

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Glucose Device: The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Early Feasibility and First in Human Study of the YANG System for Continuous Monitoring of Glucose, Ketones and Lactate - The GLOW Study
Actual Study Start Date : February 25, 2021
Actual Primary Completion Date : June 19, 2021
Actual Study Completion Date : June 19, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: YANG system group Device: The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement
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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of device-related or sensor insertion/removal procedure-related adverse events [ Time Frame: 57 days ]
  2. 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

  3. Incidence of sensor failure [ Time Frame: 27 days ]

Secondary Outcome Measures :
  1. Collection of users feedback in the form of clinical questionnaire to assess the 'easiness' of surgical procedure with questionnaire [ Time Frame: 1 day ]
  2. Requirements of duration of implantation and explantation procedure [ Time Frame: 27 days ]
  3. Post explantation follow-up [ Time Frame: 30 days ]
    Removal of sutures and wound healing after 10 days post explantation of the sensor. Follow-up via phone call after 30 days


Other Outcome Measures:
  1. Assessment of sensor ability to measure glucose and β-hydroxybutyrate and lactate levels to allow the development of the algorithm [ Time Frame: 27 days ]
    Exploratory endpoint

  2. Assessment of influence of interference substances (i.e. ethanol, lactate, ketones, paracetamol, acetylsalicylic acid, sorbitol, fructose, aspartame, ibuprofen, caffeine and ascorbic acid [Vitamin C]) [ Time Frame: 27 days ]
    Exploratory endpoint: blood samples will be taken each 2.5 or 5 min to measure glucose, lactate and ketones. Glucose will also be measured with a CGM. The influence of the confounders on the glucose measurement by the sensor in the interstitial fluid will be investigated.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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
  • 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

Exclusion Criteria:

  • 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
  • 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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04782934


Locations
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Belgium
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
Indigo Diabetes NV
University Hospital, Antwerp
Investigators
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Principal Investigator: Christophe De Block, Prof. Dr. University Hospital, Antwerp
More Information
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Responsible Party: Indigo Diabetes NV
ClinicalTrials.gov Identifier: NCT04782934    
Other Study ID Numbers: IND007
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No