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 @ 3:14 AM
Ignite Modification Date:
2025-12-25 @ 3:14 AM
NCT ID:
NCT05597605
Eligibility Criteria:
Inclusion Criteria:
* Subjects willing to sign an informed consent form (ICF)
* Adult subjects, age ≥ 18
* Subjects willing to comply to study protocol requirements (study visits with frequent venous blood sampling and deliberate insulin, glucose, ketone and lactate (sub study only) challenges)
* Subjects willing to wear a Dexcom G6 CGM during duration of the study
* Subjects willing to charge the FUSHO SENSOR/ED and CHARGER on daily basis
* Patients with type 1 diabetes mellitus (T1DM) according to WHO criteria, diagnosed for at least 12 months prior to screening, on Multiple Daily Injections (MDI), not on insulin pump treatment during the course of the study
* Patients with type 2 diabetes mellitus (T2DM) on Intensive Insulin Therapy (IIT), with a minimum of four injections per day and known dosing parameters
Exclusion Criteria:
* Known allergy to PDMS
* Subjects with a contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, untreated hypothyroidism)
* History of severe hypoglycaemia in the previous 6 months. Severe hypoglycaemia is defined as hypoglycaemia resulting in loss of consciousness or seizure
* History of diabetic ketoacidosis requiring emergency room visit or hospitalization in the previous 6 months
* History of, hepatitis C or HIV or other disease transmissible by blood
* 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
* Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor are allowed).
* Anemia identified by a haemoglobin \<14 g/dL for men or \<12 g/dL for women
* The presence of any other active implanted device
* The presence of any other CGM sensor or transmitter located in lower abdomen or back (other location is acceptable)
* Waist circumference of \>120 cm
* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05597605
Study Brief:
Protocol Section:
NCT05597605