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

Indigo Diabetes NV1 site in 1 country7 target enrollmentFebruary 25, 2021

ConditionsDiabetes Mellitus Glucose

Overview

Phase: N/A
Intervention: Not specified
Conditions: Diabetes Mellitus
Sponsor: Indigo Diabetes NV
Enrollment: 7
Locations: 1
Primary Endpoint: Incidence of device-related or sensor insertion/removal procedure-related adverse events
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 25, 2021

End Date

June 19, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Indigo Diabetes NV

Responsible Party

Sponsor

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

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.

Outcomes

Primary Outcomes

Incidence of device-related or sensor insertion/removal procedure-related adverse events

Time Frame: 57 days

Assessment of foreign body reaction due subcutaneous implantation with biopsy

Time Frame: 27 days

Assessment of i.e. inflammation, infection, tissue vascularization, formation of fibrotic scar tissue

Incidence of sensor failure

Time Frame: 27 days

Secondary Outcomes

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)