The GLOW Study - The YANG System

NCT04782934 | Completed

• 1 other identifier: IND007
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Glucose

Outcome Measures

Primary Outcomes (3)

• Incidence of device-related or sensor insertion/removal procedure-related adverse events

  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

  27 days

• Incidence of sensor failure

  27 days

Secondary Outcomes (3)

• Collection of users feedback in the form of clinical questionnaire to assess the 'easiness' of surgical procedure with questionnaire

  1 day

• Requirements of duration of implantation and explantation procedure

  27 days

• Post explantation follow-up

  30 days

Other Outcomes (2)

• Assessment of sensor ability to measure glucose and β-hydroxybutyrate and lactate levels to allow the development of the algorithm

  27 days

• Assessment of influence of interference substances (i.e. ethanol, lactate, ketones, paracetamol, acetylsalicylic acid, sorbitol, fructose, aspartame, ibuprofen, caffeine and ascorbic acid [Vitamin C])

  27 days

Study Arms (1)

YANG system group

EXPERIMENTAL

Device: The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement

Interventions

The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement DEVICE

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.

YANG system group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indigo Diabetes NV: lead
• University Hospital, Antwerp: collaborator

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (1)

• 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.

  PMID: 38701088 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christophe De Block, Prof. Dr.

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 4, 2021
• Study Start: February 25, 2021
• Primary Completion: June 19, 2021
• Study Completion: June 19, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)