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

Study Overview
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Brief Summary
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Evaluation of Long-Term Implanted Sensor in Patients on Quality of life

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

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: eversense


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female diagnosed with type 1 diabetes mellitus Age > 18 Insulin treatment for at least 1 year (Either MDI of CSII) HbA1c < 11% Signing informed consent and willing to apply with study procedure Exclusion Criteria: History of severe hypoglycaemia in the last 3 months History of DKA in the last 3 months Any condition preventing or complicating the placement, operation or removal of the Sensor including upper extremity deformities or skin condition 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 Any condition that require MRI imaging or planned MRI during the trial period Known topical or local anaesthetic allergy Known allergy to glucocorticoids History of hepatitis B, hepatitis C or HIV Any Bleeding disorder or taking anticoagulant medication Participation in other clinical trial Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br> | Device: eversense<br>* eversense CGM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in quality of life evaluated questionnaires (DTSQ) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eversense, type 1 diabetes