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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04161651
• Other study ID #: 0047-19-COM
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2019
• Est. completion date: October 2020

Study information

• Verified date: November 2019
• Source: Meir Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• eversense
eversense CGM

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	DYN Diagnostic LTD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in quality of life evaluated questionnaires (DTSQ)		6 months
Secondary	Change in HBA1C		3 / 6 months
Secondary	CGM Time In Range (70-180 mg/dl)		3 / 6 months
Secondary	CGM Time in hypoglycaemia below 70 mg/dl		3 / 6 months
Secondary	CGM Time in hypoglycaemia below 54 mg/dl		3 / 6 months
Secondary	CGM time in range difference [2 weeks before digital visit and 2 weeks after digital visit]		3 / 6 months
Secondary	Change in HFS-ii (hypoglycaemia fear survey II)		6 months
Secondary	Change in Continuous Glucose Monitor Satisfaction Scale (CGM-SAT)		6 months
Secondary	Any adverse event related to study device		6 months