Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
1 other identifier
interventional
22
0 countries
N/A
Brief Summary
Evaluation of Long-Term Implanted Sensor in Patients on Quality of life
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 10, 2019
CompletedFirst Posted
Study publicly available on registry
November 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedNovember 20, 2019
November 1, 2019
11 months
November 10, 2019
November 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
changes in quality of life evaluated questionnaires (DTSQ)
6 months
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (1)
single arm
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Meir Medical Centerlead
- DYN Diagnostic LTDcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2019
First Posted
November 13, 2019
Study Start
November 1, 2019
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
November 20, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share