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

Not Applicable

• Conditions: Type 1 Diabetes
• Interventions: Device: eversense

• Registration Number: NCT04161651
• Lead Sponsor: Meir Medical Center

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11
• Study First Submitted: 2019-11-10
• Study First Submitted QC: 2019-11-10
• Study First Posted: 2019-11-13
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-20
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 22

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	eversense	-

Primary Outcome Measures

Name	Time	Method
changes in quality of life evaluated questionnaires (DTSQ)	6 months

Secondary Outcome Measures

Name	Time	Method
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