The GLOW Study - The YANG System

Study Overview
=================
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.

Official Title
-----------------
Early Feasibility and First in Human Study of the YANG System for Continuous Monitoring of Glucose, Ketones and Lactate - The GLOW Study

Conditions
-----------------
Glucose, Diabetes Mellitus

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


Participation Criteria
=================
Eligibility 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YANG system group<br> | Device: The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement<br>* 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.<br>|

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 |