Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
Primary Purpose
Type 1 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
eversense
Sponsored by
About this trial
This is an interventional supportive care trial for Type 1 Diabetes focused on measuring eversense, type 1 diabetes
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
Outcomes
Primary Outcome Measures
changes in quality of life evaluated questionnaires (DTSQ)
Secondary Outcome Measures
Change in HBA1C
CGM Time In Range (70-180 mg/dl)
CGM Time in hypoglycaemia below 70 mg/dl
CGM Time in hypoglycaemia below 54 mg/dl
CGM time in range difference [2 weeks before digital visit and 2 weeks after digital visit]
Change in HFS-ii (hypoglycaemia fear survey II)
Change in Continuous Glucose Monitor Satisfaction Scale (CGM-SAT)
Any adverse event related to study device
Full Information
NCT ID
NCT04161651
First Posted
November 10, 2019
Last Updated
November 18, 2019
Sponsor
Meir Medical Center
Collaborators
DYN Diagnostic LTD
1. Study Identification
Unique Protocol Identification Number
NCT04161651
Brief Title
Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
Official Title
Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2019 (Anticipated)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
Collaborators
DYN Diagnostic LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
eversense, type 1 diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
eversense
Intervention Description
eversense CGM
Primary Outcome Measure Information:
Title
changes in quality of life evaluated questionnaires (DTSQ)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in HBA1C
Time Frame
3 / 6 months
Title
CGM Time In Range (70-180 mg/dl)
Time Frame
3 / 6 months
Title
CGM Time in hypoglycaemia below 70 mg/dl
Time Frame
3 / 6 months
Title
CGM Time in hypoglycaemia below 54 mg/dl
Time Frame
3 / 6 months
Title
CGM time in range difference [2 weeks before digital visit and 2 weeks after digital visit]
Time Frame
3 / 6 months
Title
Change in HFS-ii (hypoglycaemia fear survey II)
Time Frame
6 months
Title
Change in Continuous Glucose Monitor Satisfaction Scale (CGM-SAT)
Time Frame
6 months
Title
Any adverse event related to study device
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
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