The GLOW Study - The YANG System

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Glucose
• Intervention / Treatment: Device: The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • University Hospital Antwerp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Removal of sutures and wound healing after 10 days post explantation of the sensor. Follow-up via phone call after 30 days	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of sensor ability to measure glucose and β-hydroxybutyrate and lactate levels to allow the development of the algorithm	Exploratory endpoint	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])	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.	27 days

Collaborators and Investigators

• Sponsor: Indigo Diabetes NV
• Collaborators: University Hospital, Antwerp
• Investigators: Principal Investigator: Christophe De Block, Prof. Dr., University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Actual): June 19, 2021
• Study Completion (Actual): June 19, 2021

Study Registration Dates

• First Submitted: February 24, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: IND007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No