Type 1 Diabetes
Conditions
Keywords
eversense, type 1 diabetes
Brief summary
Evaluation of Long-Term Implanted Sensor in Patients on Quality of life
Detailed 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
Interventions
DEVICEeversense
eversense CGM
Sponsors
DYN Diagnostic LTD
Meir Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes in quality of life evaluated questionnaires (DTSQ) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in HBA1C | 3 / 6 months |
| CGM Time In Range (70-180 mg/dl) | 3 / 6 months |
| CGM Time in hypoglycaemia below 70 mg/dl | 3 / 6 months |
| CGM Time in hypoglycaemia below 54 mg/dl | 3 / 6 months |
| CGM time in range difference [2 weeks before digital visit and 2 weeks after digital visit] | 3 / 6 months |
| Change in HFS-ii (hypoglycaemia fear survey II) | 6 months |
| Change in Continuous Glucose Monitor Satisfaction Scale (CGM-SAT) | 6 months |
| Any adverse event related to study device | 6 months |
Outcome results
None listed