Type 1 DiabetesNCT04161651
Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
A study testing eversense in people with Type 1 Diabetes, run by Meir Medical Center.
Trial summary
Evaluation of Long-Term Implanted Sensor in Patients on Quality of life Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- eversense
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
About this study
Evaluation of Long-Term Implanted Sensor in Patients on Quality of life
Read the 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
- Conditions
- Type 1 Diabetes
- Being tested
- eversense
- Keywords
- eversense, type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eversenseDevice
eversense CGM
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Not described Receives: Device: eversense |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in quality of life evaluated questionnaires (DTSQ)
Measured: 6 months
Secondary outcomes (8)
Change in HBA1C
Measured: 3 / 6 months
CGM Time In Range (70-180 mg/dl)
Measured: 3 / 6 months
CGM Time in hypoglycaemia below 70 mg/dl
Measured: 3 / 6 months
CGM Time in hypoglycaemia below 54 mg/dl
Measured: 3 / 6 months
CGM time in range difference [2 weeks before digital visit and 2 weeks after digital visit]
Measured: 3 / 6 months
Change in HFS-ii (hypoglycaemia fear survey II)
Measured: 6 months
Change in Continuous Glucose Monitor Satisfaction Scale (CGM-SAT)
Measured: 6 months
Any adverse event related to study device
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study startNov 2019 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- DYN Diagnostic LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161651
- Sponsor's protocol ID
- 0047-19-COM
- Status last verified
- Nov 2019
- First submitted
- 10 Nov 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Long-Term Implanted Sensor in Patients on Quality of Life
- ClinicalTrials.gov ID
- NCT04161651
- Acronym / sponsor ID
- 0047-19-COM
- Conditions
- Type 1 Diabetes
- Keywords
- eversense, type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Collaborators
- DYN Diagnostic LTD
- Study start
- Nov 2019 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Device: eversense |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eversenseeversense CGM | Device | single arm |
Primary outcome
changes in quality of life evaluated questionnaires (DTSQ)
Time frame: 6 months
8 secondary outcomes
Change in HBA1C
Time frame: 3 / 6 months
CGM Time In Range (70-180 mg/dl)
Time frame: 3 / 6 months
CGM Time in hypoglycaemia below 70 mg/dl
Time frame: 3 / 6 months
CGM Time in hypoglycaemia below 54 mg/dl
Time frame: 3 / 6 months
CGM time in range difference [2 weeks before digital visit and 2 weeks after digital visit]
Time frame: 3 / 6 months
Change in HFS-ii (hypoglycaemia fear survey II)
Time frame: 6 months
Change in Continuous Glucose Monitor Satisfaction Scale (CGM-SAT)
Time frame: 6 months
Any adverse event related to study device
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing eversense in people with Type 1 Diabetes, run by Meir Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in quality of life evaluated questionnaires (DTSQ) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.