Clinical trial NCT04782934: The GLOW Study - The YANG System
Official title: Early Feasibility and First in Human Study of the YANG System for Continuous Monitoring of Glucose, Ketones and Lactate - The GLOW Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Glucose
Lead sponsor: Indigo Diabetes NV
Sponsor class: INDUSTRY
Collaborators: name: University Hospital, Antwerp
First posted: 2021-03-04
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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)

Primary outcomes:
measure: Incidence of device-related or sensor insertion/removal procedure-related adverse events
timeFrame: 57 days
measure: Assessment of foreign body reaction due subcutaneous implantation with biopsy
timeFrame: 27 days
measure: Incidence of sensor failure
timeFrame: 27 days
Secondary outcomes:
measure: Collection of users feedback in the form of clinical questionnaire to assess the 'easiness' of surgical procedure with questionnaire
timeFrame: 1 day
measure: Requirements of duration of implantation and explantation procedure
timeFrame: 27 days
measure: Post explantation follow-up
timeFrame: 30 days
Other outcomes:
measure: Assessment of sensor ability to measure glucose and β-hydroxybutyrate and lactate levels to allow the development of the algorithm
timeFrame: 27 days
measure: Assessment of influence of interference substances (i.e. ethanol, lactate, ketones, paracetamol, acetylsalicylic acid, sorbitol, fructose, aspartame, ibuprofen, caffeine and ascorbic acid [Vitamin C])
timeFrame: 27 days
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Christophe De Block, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: