Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life

Clalit Health Services

Status: Unknown

Conditions: Type 1 Diabetes

Treatments: Device: eversense

Study type: Interventional

Funder types: Other

Identifiers

NCT04161651

0047-19-COM

Details and patient eligibility

About

Evaluation of Long-Term Implanted Sensor in Patients on Quality of life

Full description

Assess satisfaction and acceptance of long-term implanted single sensor use (eversense XL) for up to 6 months in type 1 insulin-using patients

Enrollment: 22 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or Female diagnosed with type 1 diabetes mellitus
2. Age > 18
3. Insulin treatment for at least 1 year (Either MDI of CSII)
4. HbA1c < 11%
5. Signing informed consent and willing to apply with study procedure

Exclusion criteria

1. History of severe hypoglycaemia in the last 3 months
2. History of DKA in the last 3 months
3. Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition
4. Female subjects of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study
5. Any condition that require MRI imaging or planned MRI during the trial period
6. Known topical or local anaesthetic allergy
7. Known allergy to glucocorticoids
8. History of hepatitis B, hepatitis C or HIV
9. Any Bleeding disorder or taking anticoagulant medication
10. Participation in other clinical trial
11. Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

single arm

Experimental group

Treatment:

Device: eversense