The GLOW Study - The YANG System

Indigo Diabetes

Status

Completed

Conditions

Diabetes Mellitus

Glucose

Treatments

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

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04782934

IND007

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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)