Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT04782934
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04782934
Study Brief:
Protocol Section:
NCT04782934