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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

Tracking Information
First Submitted Date  ICMJE February 24, 2021
First Posted Date  ICMJE March 4, 2021
Last Update Posted Date September 21, 2021
Actual Study Start Date  ICMJE February 25, 2021
Actual Primary Completion Date June 19, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2021)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2021)
  • 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 ]
    Removal of sutures and wound healing after 10 days post explantation of the sensor. Follow-up via phone call after 30 days
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 2, 2021)
  • 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
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The GLOW Study - The YANG System
Official Title  ICMJE Early Feasibility and First in Human Study of the YANG System for Continuous Monitoring of Glucose, Ketones and Lactate - The GLOW Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE
  • Diabetes Mellitus
  • Glucose
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: YANG system group
Intervention: Device: The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2021)
7
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 19, 2021
Actual Primary Completion Date June 19, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04782934
Other Study ID Numbers  ICMJE IND007
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Indigo Diabetes NV
Study Sponsor  ICMJE Indigo Diabetes NV
Collaborators  ICMJE University Hospital, Antwerp
Investigators  ICMJE
Principal Investigator: Christophe De Block, Prof. Dr. University Hospital, Antwerp
PRS Account Indigo Diabetes NV
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP