The GLOW Study - The YANG System

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Glucose
• Interventions: Device: The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement

• Registration Number: NCT04782934
• Lead Sponsor: Indigo Diabetes NV

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-24
• Study Start: 2021-02-25
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-04
• Primary Completion: 2021-06-19
• Study Completion: 2021-06-19
• Last Update Submitted: 2021-09-20
• Last Update Posted: 2021-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
YANG system group	The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement	-

Primary Outcome Measures

Name	Time	Method
Incidence of device-related or sensor insertion/removal procedure-related adverse events	57 days
Assessment of foreign body reaction due subcutaneous implantation with biopsy	27 days	Assessment of i.e. inflammation, infection, tissue vascularization, formation of fibrotic scar tissue
Incidence of sensor failure	27 days

Secondary Outcome Measures

Name	Time	Method
Collection of users feedback in the form of clinical questionnaire to assess the 'easiness' of surgical procedure with questionnaire	1 day
Requirements of duration of implantation and explantation procedure	27 days
Post explantation follow-up	30 days	Removal of sutures and wound healing after 10 days post explantation of the sensor. Follow-up via phone call after 30 days

Trial Locations

Locations (1)

University Hospital Antwerp; 🇧🇪 Edegem, Antwerp, Belgium