Type 2 DiabetesNCT02809365
FreeStyle Libre- Effect on QOL in Type 2 Diabetes Patients
A study testing FreeStyle Libre and personal glucometer in people with Type 2 Diabetes, run by Wolfson Medical Center at 2 sites in Israel.
Trial summary
This is a randomized controlled study in type 2 diabetic patients who are presently uncontrolled on at least 2 injections of insulin daily with an A1C >7.5 % and <10%. Patients need to be stabilized on their MDI for 1 week then randomized to either SBGM or FreeStyle Libre for 10 weeks. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- FreeStyle Libre and personal glucometer
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesIsrael
- Study dates
- Sep 2016to 31 Oct 2017
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes - more than 1 year
- Age: 30 - 80 yrs
- Treated with MDI: ≥ 2 injections daily
- HbA1c: 7.5% to 10%
- Willing to measure 7 daily blood tests at least one day each week
- Willing to sign informed consent
Who cannot join
- Type 1 diabetes
- CV event within the last 6 months
- Steroid therapy > 7 days in last 6 months
- Retinopathy - grade 3
- Creatinine >2 mg%
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
E. Wolfson Medical Center
Holon, 58100
Wolfson Medical Center, Bariatric Surgery Clinic
Holon, 58100
About this study
Official title: The Impact on Quality of Life of Novel Glucose -Sensing Technology Used by Individuals With Type 2 Diabetes on Intensive-insulin Therapy
This is a randomized controlled study in type 2 diabetic patients who are presently uncontrolled on at least 2 injections of insulin daily with an A1C >7.5 % and <10%. Patients need to be stabilized on their MDI for 1 week then randomized to either SBGM or FreeStyle Libre for 10 weeks.
Read the detailed description
FreeStyle Libre Flash Glucose Monitoring System is an interstitial glucose monitoring system intended to be replacement for the capillary blood glucose measurement. The system contains several features that distinguish it from exiting sensor technology including no user calibration during 14 days of wear. The sensor is applied to the upper arm of the patient and the hand-held reader is used to scan the sensor to receive glucose result along with historic results with a 15 min frequency for up to 8 hours.
An AGP (=Ambulatory Glucose Profile) report is a way to present the glucose data collected by the time of day that has several advantages: demonstrates median glucose levels and the 25-75%, 10-90% excursions as well as the tendency for hypo or hyperglycemia throughout the day. This integration of results gives a more complete picture of the glucose control throughout the week/s while eliminating the "noise" from outliers.
The hypothesis is that the addition of FreeStyle Libre system for 10 weeks to the treatment of uncontrolled Type 2 diabetic patients currently on MDI, will produce a modification of behavior/life style and improvement in treatment satisfaction, quality of life and glycemic control and reduce the number of any/major hypoglycemia events.
- Conditions
- Type 2 Diabetes
- Being tested
- FreeStyle Libre, personal glucometer
- Keywords
- insulin treated
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle LibreDevice
Addition of FreeStyle Libre system for 10 weeks to the treatment of uncontrolled Type 2 diabetic patients currently on multiple daily injections
personal glucometerDevice
Also called SMBG
Subjects in the Control Group will measure blood glucose levels by personal glucometer (SMBG = self monitoring blood glucose)
| Study group | Role | What they receive |
|---|---|---|
| Libre | Other | FreeStyle Libre users: FreeStyle Libre Flash Glucose Monitoring System is an interstitial glucose monitoring system intended to be replacement for the capillary blood glucose measurement. The system contains several features that distinguish it from exiting sensor technology including no user calibration during 14 days of wear. The sensor is applied to the upper arm of the patient and the hand-held reader is used to scan the sensor to receive glucose result along with historic results with a 15 min frequency for up to 8 hours. Receives: Device: FreeStyle Libre |
| SMBG | Other | Self monitoring blood glucose: patients in this arm will measure blood glucose with personal glucometer Receives: Device: personal glucometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction Questionnaire' (DTSQ)
Measured: 10 weeks
Secondary outcomes (6)
Improvement of quality of life.
This outcome will be measured by a validated diabetes - specific quality of life questionnaire (DQOL).
Measured: 10 weeks
Assessment of satisfaction from the FreeStyle Libre system
This outcome will be measure by a questionnaire developed by the investigators using specific items evaluating the use of the Libre System.
Measured: 10 weeks
Improvement of HbA1c
This outcome will be measured in capillary blood sample.
Measured: 10 weeks
Percent to reach target HbA1c as defined personally by the physician
This outcome will be assessed using the result of the HbA1c.
Measured: 10 weeks
Reduction in hypoglycemic events <54 mg%
By comparing events of glucose levels below 54 mg% in the intervention group versus the control group.
Measured: 10 weeks
Reduction in hypoglycemic events <70 mg%
By comparing events of glucose levels below 70 mg% in the intervention group versus the control group.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startSep 2016
- Primary completion31 Jul 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, zohar landau, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809365
- Sponsor's protocol ID
- 0096-16-WOMC
- Status last verified
- Nov 2017
- First submitted
- 8 Jun 2016
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yaron M, Roitman E, Aharon-Hananel G, Landau Z, Ganz T, Yanuv I, Rozenberg A, Karp M, Ish-Shalom M, Singer J, Wainstein J, Raz I. Effect of Flash Glucose Monitoring Technology on Glycemic Control and Treatment Satisfaction in Patients With Type 2 Diabetes. Diabetes Care. 2019 Jul;42(7):1178-1184. doi: 10.2337/dc18-0166. Epub 2019 Apr 29.
PubMed 31036546
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact on Quality of Life of Novel Glucose -Sensing Technology Used by Individuals With Type 2 Diabetes on Intensive-insulin Therapy
- ClinicalTrials.gov ID
- NCT02809365
- Acronym / sponsor ID
- 0096-16-WOMC
- Conditions
- Type 2 Diabetes
- Keywords
- insulin treated
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- Sep 2016
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 22 Jun 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.
This is a randomized controlled study in type 2 diabetic patients who are presently uncontrolled on at least 2 injections of insulin daily with an A1C >7.5 % and <10%. Patients need to be stabilized on their MDI for 1 week then randomized to either SBGM or FreeStyle Libre for 10 weeks.
Detailed description
FreeStyle Libre Flash Glucose Monitoring System is an interstitial glucose monitoring system intended to be replacement for the capillary blood glucose measurement. The system contains several features that distinguish it from exiting sensor technology including no user calibration during 14 days of wear. The sensor is applied to the upper arm of the patient and the hand-held reader is used to scan the sensor to receive glucose result along with historic results with a 15 min frequency for up to 8 hours.
An AGP (=Ambulatory Glucose Profile) report is a way to present the glucose data collected by the time of day that has several advantages: demonstrates median glucose levels and the 25-75%, 10-90% excursions as well as the tendency for hypo or hyperglycemia throughout the day. This integration of results gives a more complete picture of the glucose control throughout the week/s while eliminating the "noise" from outliers.
The hypothesis is that the addition of FreeStyle Libre system for 10 weeks to the treatment of uncontrolled Type 2 diabetic patients currently on MDI, will produce a modification of behavior/life style and improvement in treatment satisfaction, quality of life and glycemic control and reduce the number of any/major hypoglycemia events.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Libre | Other | Device: FreeStyle LibreFreeStyle Libre users: FreeStyle Libre Flash Glucose Monitoring System is an interstitial glucose monitoring system intended to be replacement for the capillary blood glucose measurement. The system contains several features that distinguish it from exiting sensor technology including no user calibration during 14 days of wear. The sensor is applied to the upper arm of the patient and the hand-held reader is used to scan the sensor to receive glucose result along with historic results with a 15 min frequency for up to 8 hours. |
| SMBG | Other | Device: personal glucometerSelf monitoring blood glucose: patients in this arm will measure blood glucose with personal glucometer |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Type 2 diabetes - more than 1 year
- Age: 30 - 80 yrs
- Treated with MDI: ≥ 2 injections daily
- HbA1c: 7.5% to 10%
- Willing to measure 7 daily blood tests at least one day each week
Key exclusion criteria (5 listed)
- Type 1 diabetes
- CV event within the last 6 months
- Steroid therapy > 7 days in last 6 months
- Retinopathy - grade 3
- Creatinine >2 mg%
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 |
|---|---|---|
| FreeStyle LibreAddition of FreeStyle Libre system for 10 weeks to the treatment of uncontrolled Type 2 diabetic patients currently on multiple daily injections | Device | Libre |
| personal glucometerAlso: SMBGSubjects in the Control Group will measure blood glucose levels by personal glucometer (SMBG = self monitoring blood glucose) | Device | SMBG |
Primary outcome
Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction Questionnaire' (DTSQ)
Time frame: 10 weeks
6 secondary outcomes
Improvement of quality of life.
Time frame: 10 weeks
Assessment of satisfaction from the FreeStyle Libre system
Time frame: 10 weeks
Improvement of HbA1c
Time frame: 10 weeks
Percent to reach target HbA1c as defined personally by the physician
Time frame: 10 weeks
Reduction in hypoglycemic events <54 mg%
Time frame: 10 weeks
Reduction in hypoglycemic events <70 mg%
Time frame: 10 weeks
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 17 Nov 2017.
- Derived from this study: PubMed 31036546Yaron M, Roitman E, Aharon-Hananel G, Landau Z, Ganz T, Yanuv I, Rozenberg A, Karp M, Ish-Shalom M, Singer J, Wainstein J, Raz I. Effect of Flash Glucose Monitoring Technology on Glycemic Control and Treatment Satisfaction in Patients With Type 2 Diabetes. Diabetes Care. 2019 Jul;42(7):1178-1184. doi: 10.2337/dc18-0166. Epub 2019 Apr 29.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre and personal glucometer in people with Type 2 Diabetes, run by Wolfson Medical Center at 2 sites 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 5 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 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Improvement of diabetes treatment satisfaction measured by the 'Diabetes Treatment Satisfaction Questionnaire' (DTSQ) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02809365, which also lists 1 linked publication.
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 17 Nov 2017.