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

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

Study Overview

• Status: Unknown
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: eversense

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

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: single arm	Device: eversense; eversense CGM

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Meir Medical Center
• Collaborators: DYN Diagnostic LTD

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): November 1, 2019
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): October 1, 2020

Study Registration Dates

• First Submitted: November 10, 2019
• First Submitted That Met QC Criteria: November 10, 2019
• First Posted (ACTUAL): November 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 18, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: type 1 diabetes; eversense
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 0047-19-COM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No