Status:
COMPLETED
The GLOW Study - The YANG System
Lead Sponsor:
Indigo Diabetes NV
Collaborating Sponsors:
University Hospital, Antwerp
Conditions:
Diabetes Mellitus
Glucose
Eligibility:
All Genders
18-50 years
Phase:
NA
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 ad...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 19 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04782934
Start Date
February 25 2021
End Date
June 19 2021
Last Update
September 21 2021
Active Locations (1)
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1
University Hospital Antwerp
Edegem, Antwerp, Belgium, 2650