The GLOW Study - The YANG System

Diabetes Mellitus Clinical Trial

Official title:

Early Feasibility and First in Human Study of the YANG System for Continuous Monitoring of Glucose, Ketones and Lactate - The GLOW Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782934
• Other study ID #: IND007
• Status: Completed
• Phase: N/A
• Start date: February 25, 2021
• Est. completion date: June 19, 2021

Study information

• Verified date: March 2021
• Source: Indigo Diabetes NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 19, 2021
• Est. primary completion date: June 19, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose

Intervention

Device:
• The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement
The YANG SENSOR is an active implantable device, that is intended to be implanted in the subcutaneous abdominal tissue, approximately 10mm below the skin. The SENSOR is battery powered. The battery is wirelessly recharged through the skin by the YANGEXD, using a charging coil ('Donut') applied to the skin with an adhesive patch at the level of the SENSOR. The 'Donut' also receives data from the sensor.

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerp

Sponsors (2)

Lead Sponsor	Collaborator
Indigo Diabetes NV	University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of sensor ability to measure glucose and ß-hydroxybutyrate and lactate levels to allow the development of the algorithm	Exploratory endpoint	27 days
Other	Assessment of influence of interference substances (i.e. ethanol, lactate, ketones, paracetamol, acetylsalicylic acid, sorbitol, fructose, aspartame, ibuprofen, caffeine and ascorbic acid [Vitamin C])	Exploratory endpoint: blood samples will be taken each 2.5 or 5 min to measure glucose, lactate and ketones. Glucose will also be measured with a CGM. The influence of the confounders on the glucose measurement by the sensor in the interstitial fluid will be investigated.	27 days
Primary	Incidence of device-related or sensor insertion/removal procedure-related adverse events		57 days
Primary	Assessment of foreign body reaction due subcutaneous implantation with biopsy	Assessment of i.e. inflammation, infection, tissue vascularization, formation of fibrotic scar tissue	27 days
Primary	Incidence of sensor failure		27 days
Secondary	Collection of users feedback in the form of clinical questionnaire to assess the 'easiness' of surgical procedure with questionnaire		1 day
Secondary	Requirements of duration of implantation and explantation procedure		27 days
Secondary	Post explantation follow-up	Removal of sutures and wound healing after 10 days post explantation of the sensor. Follow-up via phone call after 30 days	30 days