Type 1 DiabetesNCT02776007
Patients Perceptions of Using the "Libre" System Compared With Conventional SMBG in Adolescents With Type 1 Diabetes The Libre Sat Trial
A study testing Libre Flash CGMS and Self-Measurement Blood Glucose in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The Libre- flash glucose monitoring system is an episodic real-time data on demand device. This means that patients can measure their glucose level when they choose by scanning the device, while at the same time a sensor automatically measures and continuously stores glucose readings day and night. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Libre Flash CGMS and Self-Measurement Blood Glucose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2016to 30 Apr 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The subject has documented Type 1 Diabetes , as defined by the American Diabetes Association and World Health Organization for at least 1 year prior to study enrollment
- The subject used continuous glucose monitoring until 3 months or more before the study start
- Age 12-17 years
- The subject has an HbA1c value > 7.5% at time of screening visit
- The subject is willing to follow study instructions
- Subject is available for entire study duration
Who cannot join
- Concomitant diseases that influence metabolic control or other medical condition, which in the Investigator's opinion, may compromise patient safety
- Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study
- Any significant diseases or conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety
- Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior to screening, or plans to take oral or parenteral glucocorticoids within the planned study duration. Exceptions: Short term oral or parenteral glucocorticoids up to 7 days
- Subject has known allergy to medical grade adhesives
- Subject is participating in another study of a medical device or drug that could affect glucose measurements or glucose management or receipt of any investigational medical product within 1 month prior to screening
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- Female subject of child-bearing potential who have a positive pregnancy test at screening, is pregnant, breast-feeding, or planning to become pregnant within the planned study duration or is not using adequate contraceptive methods
- Subject diagnosed with current eating disorder such as anorexia or bulimia
- Subject has a history of one or more episodes of Diabetes Keto-Acidosis requiring hospitalization within a month prior to screening
- Subject has unstable or rapidly progressive renal disease or is receiving dialysis
- Subject has active proliferating retinopathy
- Subject has current or recent history of alcohol or drug abuse
- Subject has visual impairment or hearing loss, which in the Investigator's opinion, may compromise patient ability to perform study procedures safely
- Any disease or condition that may influence the HbA1C testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patients Perceptions of Using the Libre System Compared With Conventional SMBG in Adolescents With Type 1 Diabetes The Libre Sat Trial
The Libre- flash glucose monitoring system is an episodic real-time data on demand device. This means that patients can measure their glucose level when they choose by scanning the device, while at the same time a sensor automatically measures and continuously stores glucose readings day and night. Every scan shows the current glucose reading and the last 8 hours of glucose. There are no alarms and the system does not require calibration.
In the present study we aim to evaluate treatment satisfaction and comfort using the Libre flash glucose monitoring system compared to conventional Self Measurement of Blood Glucose (SMBG) in adolescents with type 1 diabetes that discontinued using continuous glucose monitoring.
The second aim of the study is to evaluate the rate of use and the impact of Libre use compared to Self-Measurement of Blood Glucose among adolescents who are sub-optimally controlled and stopped using Continuous Glucose Monitoring. The study is an investigator initiated study, single-center, randomized, parallel study of 12 weeks with an optional cross-over 12 weeks extension period .
- Conditions
- Type 1 Diabetes
- Being tested
- Libre Flash CGMS, Self-Measurement Blood Glucose
- Keywords
- Continuous Glucose Monitoring System
- 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.
Libre Flash CGMSDevice
Self-Measurement Blood GlucoseDevice
Patients will use their personal glucose meter to perform Self-Measurement Blood Glucose
| Study group | Role | What they receive |
|---|---|---|
| Libre Flash CGMS (Continuous Monitoring System) | Experimental | Patients will use the Libre Flash Continuous Glucose Monitoring System for 12 weeks for their glucose Management Receives: Device: Libre Flash CGMS |
| SMBG | Active comparator | Patients will use Self-Monitoring of Blood Glucose for 12 weeks for their glucose management Receives: Device: Self-Measurement Blood Glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Treatment satisfaction questionnaire
Measured: At the final visit- week 12
Libre-user evaluation questionnaire
20-item questionnaire that asses treatment satisfaction with the Libre including ease of use, comfort, pain, design and system operation. The questionnaire will be scored to a final score integrating all items to a total score
Measured: At the final visit-week 12
Secondary outcomes (1)
Glycemic control measured by HbA1c
Measured: At the final visit-week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startJul 2016
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776007
- Sponsor's protocol ID
- RMC023516Ctil
- Status last verified
- Aug 2022
- First submitted
- 12 Apr 2016
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients Perceptions of Using the Libre System Compared With Conventional SMBG in Adolescents With Type 1 Diabetes The Libre Sat Trial
- ClinicalTrials.gov ID
- NCT02776007
- Acronym / sponsor ID
- RMC023516Ctil
- Conditions
- Type 1 Diabetes
- Keywords
- Continuous Glucose Monitoring System
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jul 2016 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 18 May 2016 (estimated)
- 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.
The Libre- flash glucose monitoring system is an episodic real-time data on demand device. This means that patients can measure their glucose level when they choose by scanning the device, while at the same time a sensor automatically measures and continuously stores glucose readings day and night. Every scan shows the current glucose reading and the last 8 hours of glucose. There are no alarms and the system does not require calibration.
In the present study we aim to evaluate treatment satisfaction and comfort using the Libre flash glucose monitoring system compared to conventional Self Measurement of Blood Glucose (SMBG) in adolescents with type 1 diabetes that discontinued using continuous glucose monitoring.
The second aim of the study is to evaluate the rate of use and the impact of Libre use compared to Self-Measurement of Blood Glucose among adolescents who are sub-optimally controlled and stopped using Continuous Glucose Monitoring. The study is an investigator initiated study, single-center, randomized, parallel study of 12 weeks with an optional cross-over 12 weeks extension period .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Libre Flash CGMS (Continuous Monitoring System) | Experimental | Device: Libre Flash CGMSPatients will use the Libre Flash Continuous Glucose Monitoring System for 12 weeks for their glucose Management |
| SMBG | Active comparator | Device: Self-Measurement Blood GlucosePatients will use Self-Monitoring of Blood Glucose for 12 weeks for their glucose management |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The subject has documented Type 1 Diabetes , as defined by the American Diabetes Association and World Health Organization for at least 1 year prior to study enrollment
- The subject used continuous glucose monitoring until 3 months or more before the study start
- Age 12-17 years
- The subject has an HbA1c value > 7.5% at time of screening visit
- The subject is willing to follow study instructions
Key exclusion criteria (14 listed)
- Concomitant diseases that influence metabolic control or other medical condition, which in the Investigator's opinion, may compromise patient safety
- Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study
- Any significant diseases or conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety
- Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior to screening, or plans to take oral or parenteral glucocorticoids within the planned study duration. Exceptions: Short term oral or parenteral glucocorticoids up to 7 days
- Subject has known allergy to medical grade adhesives
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 |
|---|---|---|
| Libre Flash CGMS | Device | Libre Flash CGMS (Continuous Monitoring System) |
| Self-Measurement Blood GlucosePatients will use their personal glucose meter to perform Self-Measurement Blood Glucose | Device | SMBG |
Primary outcome
Diabetes Treatment satisfaction questionnaire
Time frame: At the final visit- week 12
Libre-user evaluation questionnaire
Time frame: At the final visit-week 12
20-item questionnaire that asses treatment satisfaction with the Libre including ease of use, comfort, pain, design and system operation. The questionnaire will be scored to a final score integrating all items to a total score
1 secondary outcome
Glycemic control measured by HbA1c
Time frame: At the final visit-week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Libre Flash CGMS and Self-Measurement Blood Glucose in people with Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
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 6 inclusion and 14 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: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diabetes Treatment satisfaction questionnaire (time frame: At the final visit- week 12). The study lists 2 primary outcomes in all. 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 9 Aug 2022.