NCT05597605Completed
The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
The SHINE Study: An Open Label, Interventional, Multicentre, Prospective Feasibility Study, Designed to Evaluate the Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
Source: ClinicalTrials.gov · Last updated 15 Mar 2024
Brief summary (registry, in English)
The objectives of SHINE study are to confirm the safety aspects of the SHINE SYSTEM. Moreover, the goal of this clinical investigation is the initial evaluation of sensor's performance by assessing sensor's ability to qualitatively detect the appropriate analytes in subjects with diabetes of 18 years and older.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 19 Sept 2022
- Start date
- 21 Sept 2022
- Primary completion date
- 19 Dec 2023
- Lead sponsor
- Indigo Diabetes NV
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT05597605
What you commit to
- Study type: Interventional
- Participants enrolled: 6
- From 21 Sept 2022 to the primary completion date, 19 Dec 2023
- 3 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Known allergy to PDMS
- Subjects with a contraindication to undergo challenging tests (i.e., ischemic heart disease, epilepsy, panhypopituitarism, hypoadrenalism, untreated hypothyroidism)
- 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
- Coagulation disorder, wound healing and bleeding disorder or taking anticoagulant medication (oral anticoagulants; antiplatelets (such as aspirin, ticagrelor are allowed).
- Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
Lab values
- Anemia identified by a haemoglobin \<14 g/dL for men or \<12 g/dL for women
Other
- Female subjects who are pregnant, planning on becoming pregnant or nursing
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital, Antwerp Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| Lapeyronie Montpellier University Hospital Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| University Medical Centre Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.