Diabetes Mellitus, Type 2Phase 2Diabetes type2NCT06624553
Satisfaction With FreeStyle Libre 2 Monitoring Versus Capillary Blood Glucose Monitoring in People With DM2
A Phase 2 study testing FreeStyle Libre 2, flash glucose monitoring in people with Diabetes Mellitus, Type 2, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The FreeStyle Libre 2 system is a Flash glucose monitoring system that, after a scan, provides information on interstitial glucose for the last 8 hours in the form of a reading every 15 min. The system is approved for non-adjuvant use for therapeutic decision-making. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- FreeStyle Libre 2, flash glucose monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 28 Nov 2022to 28 May 2023
- Phase
- Phase 2
- 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
- Diagnosed with DM2.
- . Who have reached 18 years of age.
- Who are candidates to start glucose monitoring according to the usual clinical practice of the Endocrine Day Hospital of the Hospital de Sant Pau.
- That they are not using any glucose monitoring tool. These may be patients with debut diabetes, worsening control with high HbA1c levels, or starting treatment with glucocorticoids. Patients may have any of these conditions, or similar ones, as long as they meet the other inclusion criteria and none of the exclusion criteria. Similarly, no specifications are made for drug treatment prior to or initiated at the recruitment visit.
Who cannot join
- Pregnant or expecting to be during the duration of the study.
- Assessed by the healthcare professional responsible for proposing the study to them as more harmful than beneficial their inclusion in it.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Monitoring With Freestyle Libre 2 Glucose Sensor on Treatment Satisfaction in Patients With Type 2 Diabetes Mellitus: Exploratory Study in Patients Starting Monitoring
The FreeStyle Libre 2 system is a Flash glucose monitoring system that, after a scan, provides information on interstitial glucose for the last 8 hours in the form of a reading every 15 min. The system is approved for non-adjuvant use for therapeutic decision-making. The acceptability and effectiveness of the FSL is well documented in patients with type 1 and 2 diabetes mellitus (DM2). Most of the studies in patients with DM2 have been developed in patients with insulin treatment, either basal or with multiple doses.
For all these reasons, we proposed an exploratory study to evaluate satisfaction with treatment (main variable) in people with DM2 who start glucose monitoring in the Endocrinology Day Hospital context compared to patients who use capillary blood glucose monitoring. These are patients treated in a context of debut/acute decompensation/intercurrent pathology, who will not necessarily be using insulin treatment. The aim is to know if the use of FSL2 provides benefits of user satisfaction with the treatment, assessed with the Diabetes Treatment Satisfaction Questionnaire at the end of follow-up (mean score of all items); in this context.
Read the detailed description
When the doctor determines that the patient who has attended the Endocrinology and Nutrition Day Hospital needs to start glucose monitoring and goes to the nursing office, if he meets the inclusion criteria, he will be asked to participate in the study. After signing the informed consent, the control group (MGC) or intervention group (FSL2) will be randomised. The necessary therapeutic education for glucose monitoring will be carried out in parallel with the other necessary aspects of Diabetes Therapeutic Education.
Follow-up visits in both groups will take place 24-48 hours after the first visit, a week, 2 weeks, and 1, 2, and 3 months after the first visit. During visits, frequently according to usual clinical practice, by the nurse and/or doctor, therapeutic decisions will be made based on the monitoring system assigned to the patient.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- FreeStyle Libre 2, flash glucose monitoring
- Keywords
- diabetes, glucose monitoring, satisfaction, diabetes technology
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre 2, flash glucose monitoringDevice
Currently, at the Hospital de la Santa Creu i Sant Pau, when starting monitoring in people with DM2, capillary glycemia monitoring is used, following the therapeutic education protocols in basal insulinization in the debut of DM2 and in optimization of treatment, protocols that are also applied to similar cases.
The intervention group (FreeStyle Libre 2) will be provided with the necessary material to carry out the monitoring via a glucose sensor. Satisfaction with treatment will be assessed at the final study visit.
| Study group | Role | What they receive |
|---|---|---|
| Control group. Capilary glucose monitoring | No intervention | The patient randomized to the control group, capillary glucose monitoring, will be provided with the necessary material for six weeks (Free Style Optium glucometer, puncturer, Free Style Optium strips, lancets and record book) and the objectives, technique of analysis, recording and interpretation. The patient/carer will be asked to practice before leaving the office to ensure that they perform the technique correctly and effectively. |
| Intervention group. FreeStyle Libre 2 | Experimental | The patient randomized to the intervention group (FSL2) will be provided with the necessary material for six weeks (sensor, applicator and reader or mobile application (App)) and the objectives, analysis, recording and interpretation technique will be explained. The patient will be helped to register in the application and share the data with the hospital. The patient will carry out the first readings before leaving the consultation to ensure that they are carried out correctly. Receives: Device: FreeStyle Libre 2, flash glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction with the treatment
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Measured: 3 months
Secondary outcomes (7)
Glucometrics
In each group, assess the change in blood glucose according to your monitoring method
Measured: 3 months
The total number of visits
- The total number of visits (in person, by telephone and asynchronous telematics, if applicable).
Measured: 3 months
Number of treatment
The number of treatment changes applied to the patient.
Measured: 3 months
Duration of follow-up.
Duration of follow-up. A maximum follow-up of 3 months is expected in both groups. However, earlier completion is expected if the patient is discharged, requires hospital admission or an exclusion criterion is made before performing V7
Measured: 3 months
HbA1c
The hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to your hemoglobin.
Measured: Baseline and 3 months
Perception of hiperglicemia
The value of questions 3 of the DTSQ and % of local problems as security variables.
Measured: 3 months
Perception of hypoglicemia
The value of questions 2 of the DTSQ and % of local problems as security variables.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start28 Nov 2022
- Primary completion28 Feb 2023
- Study completion28 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open and exploratory parallel randomized single-center clinical trial in a 1:1 ratio of three months duration. A computerized randomization by blocks of 10 without blinding will be performed.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624553
- Sponsor's protocol ID
- IIBSP-FSL-2021-150
- Acronym
- Diabetes type2
- Status last verified
- Oct 2024
- First submitted
- 7 Aug 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deshmukh H, Wilmot EG, Gregory R, Barnes D, Narendran P, Saunders S, Furlong N, Kamaruddin S, Banatwalla R, Herring R, Kilvert A, Patmore J, Walton C, Ryder REJ, Sathyapalan T. Effect of Flash Glucose Monitoring on Glycemic Control, Hypoglycemia, Diabetes-Related Distress, and Resource Utilization in the Association of British Clinical Diabetologists (ABCD) Nationwide Audit. Diabetes Care. 2020 Sep;43(9):2153-2160. doi: 10.2337/dc20-0738. Epub 2020 Jul 15.
PubMed 32669277American Diabetes Association Professional Practice Committee. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022 Jan 1;45(Suppl 1):S83-S96. doi: 10.2337/dc22-S006.
PubMed 34964868Saisho Y. Use of Diabetes Treatment Satisfaction Questionnaire in Diabetes Care: Importance of Patient-Reported Outcomes. Int J Environ Res Public Health. 2018 May 9;15(5):947. doi: 10.3390/ijerph15050947.
PubMed 29747423Martens T, Beck RW, Bailey R, Ruedy KJ, Calhoun P, Peters AL, Pop-Busui R, Philis-Tsimikas A, Bao S, Umpierrez G, Davis G, Kruger D, Bhargava A, Young L, McGill JB, Aleppo G, Nguyen QT, Orozco I, Biggs W, Lucas KJ, Polonsky WH, Buse JB, Price D, Bergenstal RM; MOBILE Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial. JAMA. 2021 Jun 8;325(22):2262-2272. doi: 10.1001/jama.2021.7444.
PubMed 34077499Diez-Fernandez A, Rodriguez-Huerta MD, Miron-Gonzalez R, Laredo-Aguilera JA, Martin-Espinosa NM. Flash Glucose Monitoring and Patient Satisfaction: A Meta-Review of Systematic Reviews. Int J Environ Res Public Health. 2021 Mar 18;18(6):3123. doi: 10.3390/ijerph18063123.
PubMed 33803558Fokkert M, van Dijk P, Edens M, Barents E, Mollema J, Slingerland R, Gans R, Bilo H. Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4). BMJ Open Diabetes Res Care. 2019 Dec 9;7(1):e000809. doi: 10.1136/bmjdrc-2019-000809. eCollection 2019.
PubMed 31875133Krakauer M, Botero JF, Lavalle-Gonzalez FJ, Proietti A, Barbieri DE. A review of flash glucose monitoring in type 2 diabetes. Diabetol Metab Syndr. 2021 Apr 9;13(1):42. doi: 10.1186/s13098-021-00654-3.
PubMed 33836819Bergenstal RM, Kerr MSD, Roberts GJ, Souto D, Nabutovsky Y, Hirsch IB. Flash CGM Is Associated With Reduced Diabetes Events and Hospitalizations in Insulin-Treated Type 2 Diabetes. J Endocr Soc. 2021 Feb 2;5(4):bvab013. doi: 10.1210/jendso/bvab013. eCollection 2021 Apr 1.
PubMed 33644623Evans M, Welsh Z, Ells S, Seibold A. The Impact of Flash Glucose Monitoring on Glycaemic Control as Measured by HbA1c: A Meta-analysis of Clinical Trials and Real-World Observational Studies. Diabetes Ther. 2020 Jan;11(1):83-95. doi: 10.1007/s13300-019-00720-0. Epub 2019 Oct 31.
PubMed 31673972Castellana M, Parisi C, Di Molfetta S, Di Gioia L, Natalicchio A, Perrini S, Cignarelli A, Laviola L, Giorgino F. Efficacy and safety of flash glucose monitoring in patients with type 1 and type 2 diabetes: a systematic review and meta-analysis. BMJ Open Diabetes Res Care. 2020 Jun;8(1):e001092. doi: 10.1136/bmjdrc-2019-001092.
PubMed 32487593Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2017 Feb;8(1):55-73. doi: 10.1007/s13300-016-0223-6. Epub 2016 Dec 20.
PubMed 28000140Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12.
PubMed 27634581
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Monitoring With Freestyle Libre 2 Glucose Sensor on Treatment Satisfaction in Patients With Type 2 Diabetes Mellitus: Exploratory Study in Patients Starting Monitoring
- ClinicalTrials.gov ID
- NCT06624553
- Acronym / sponsor ID
- Diabetes type2 / IIBSP-FSL-2021-150
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- diabetes, glucose monitoring, satisfaction, diabetes technology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 May 2023 (actual)
- First posted
- 3 Oct 2024 (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.
The FreeStyle Libre 2 system is a Flash glucose monitoring system that, after a scan, provides information on interstitial glucose for the last 8 hours in the form of a reading every 15 min. The system is approved for non-adjuvant use for therapeutic decision-making. The acceptability and effectiveness of the FSL is well documented in patients with type 1 and 2 diabetes mellitus (DM2). Most of the studies in patients with DM2 have been developed in patients with insulin treatment, either basal or with multiple doses.
For all these reasons, we proposed an exploratory study to evaluate satisfaction with treatment (main variable) in people with DM2 who start glucose monitoring in the Endocrinology Day Hospital context compared to patients who use capillary blood glucose monitoring. These are patients treated in a context of debut/acute decompensation/intercurrent pathology, who will not necessarily be using insulin treatment. The aim is to know if the use of FSL2 provides benefits of user satisfaction with the treatment, assessed with the Diabetes Treatment Satisfaction Questionnaire at the end of follow-up (mean score of all items); in this context.
Detailed description
When the doctor determines that the patient who has attended the Endocrinology and Nutrition Day Hospital needs to start glucose monitoring and goes to the nursing office, if he meets the inclusion criteria, he will be asked to participate in the study. After signing the informed consent, the control group (MGC) or intervention group (FSL2) will be randomised. The necessary therapeutic education for glucose monitoring will be carried out in parallel with the other necessary aspects of Diabetes Therapeutic Education.
Follow-up visits in both groups will take place 24-48 hours after the first visit, a week, 2 weeks, and 1, 2, and 3 months after the first visit. During visits, frequently according to usual clinical practice, by the nurse and/or doctor, therapeutic decisions will be made based on the monitoring system assigned to the patient.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open and exploratory parallel randomized single-center clinical trial in a 1:1 ratio of three months duration. A computerized randomization by blocks of 10 without blinding will be performed.
| Arm | Type | Receives |
|---|---|---|
| Control group. Capilary glucose monitoring | No intervention | –The patient randomized to the control group, capillary glucose monitoring, will be provided with the necessary material for six weeks (Free Style Optium glucometer, puncturer, Free Style Optium strips, lancets and record book) and the objectives, technique of analysis, recording and interpretation. The patient/carer will be asked to practice before leaving the office to ensure that they perform the technique correctly and effectively. |
| Intervention group. FreeStyle Libre 2 | Experimental | Device: FreeStyle Libre 2, flash glucose monitoringThe patient randomized to the intervention group (FSL2) will be provided with the necessary material for six weeks (sensor, applicator and reader or mobile application (App)) and the objectives, analysis, recording and interpretation technique will be explained. The patient will be helped to register in the application and share the data with the hospital. The patient will carry out the first readings before leaving the consultation to ensure that they are carried out correctly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with DM2.
- . Who have reached 18 years of age.
- Who are candidates to start glucose monitoring according to the usual clinical practice of the Endocrine Day Hospital of the Hospital de Sant Pau.
- That they are not using any glucose monitoring tool. These may be patients with debut diabetes, worsening control with high HbA1c levels, or starting treatment with glucocorticoids. Patients may have any of these conditions, or similar ones, as long as they meet the other inclusion criteria and none of the exclusion criteria. Similarly, no specifications are made for drug treatment prior to or initiated at the recruitment visit.
Key exclusion criteria (2 listed)
- Pregnant or expecting to be during the duration of the study.
- Assessed by the healthcare professional responsible for proposing the study to them as more harmful than beneficial their inclusion in it.
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 Libre 2, flash glucose monitoringCurrently, at the Hospital de la Santa Creu i Sant Pau, when starting monitoring in people with DM2, capillary glycemia monitoring is used, following the therapeutic education protocols in basal insulinization in the debut of DM2 and in optimization of treatment, protocols that are also applied to similar cases. The intervention group (FreeStyle Libre 2) will be provided with the necessary material to carry out the monitoring via a glucose sensor. Satisfaction with treatment will be assessed at the final study visit. | Device | Intervention group. FreeStyle Libre 2 |
Primary outcome
Satisfaction with the treatment
Time frame: 3 months
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
7 secondary outcomes
Glucometrics
Time frame: 3 months
The total number of visits
Time frame: 3 months
Number of treatment
Time frame: 3 months
Duration of follow-up.
Time frame: 3 months
HbA1c
Time frame: Baseline and 3 months
Perception of hiperglicemia
Time frame: 3 months
Perception of hypoglicemia
Time frame: 3 months
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 3 Oct 2024.
- Background: PubMed 32669277Deshmukh H, Wilmot EG, Gregory R, Barnes D, Narendran P, Saunders S, Furlong N, Kamaruddin S, Banatwalla R, Herring R, Kilvert A, Patmore J, Walton C, Ryder REJ, Sathyapalan T. Effect of Flash Glucose Monitoring on Glycemic Control, Hypoglycemia, Diabetes-Related Distress, and Resource Utilization in the Association of British Clinical Diabetologists (ABCD) Nationwide Audit. Diabetes Care. 2020 Sep;43(9):2153-2160. doi: 10.2337/dc20-0738. Epub 2020 Jul 15.
- Background: PubMed 34964868American Diabetes Association Professional Practice Committee. 6. Glycemic Targets: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022 Jan 1;45(Suppl 1):S83-S96. doi: 10.2337/dc22-S006.
- Background: PubMed 29747423Saisho Y. Use of Diabetes Treatment Satisfaction Questionnaire in Diabetes Care: Importance of Patient-Reported Outcomes. Int J Environ Res Public Health. 2018 May 9;15(5):947. doi: 10.3390/ijerph15050947.
- Background: PubMed 34077499Martens T, Beck RW, Bailey R, Ruedy KJ, Calhoun P, Peters AL, Pop-Busui R, Philis-Tsimikas A, Bao S, Umpierrez G, Davis G, Kruger D, Bhargava A, Young L, McGill JB, Aleppo G, Nguyen QT, Orozco I, Biggs W, Lucas KJ, Polonsky WH, Buse JB, Price D, Bergenstal RM; MOBILE Study Group. Effect of Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes Treated With Basal Insulin: A Randomized Clinical Trial. JAMA. 2021 Jun 8;325(22):2262-2272. doi: 10.1001/jama.2021.7444.
- Background: PubMed 33803558Diez-Fernandez A, Rodriguez-Huerta MD, Miron-Gonzalez R, Laredo-Aguilera JA, Martin-Espinosa NM. Flash Glucose Monitoring and Patient Satisfaction: A Meta-Review of Systematic Reviews. Int J Environ Res Public Health. 2021 Mar 18;18(6):3123. doi: 10.3390/ijerph18063123.
- Background: PubMed 31875133Fokkert M, van Dijk P, Edens M, Barents E, Mollema J, Slingerland R, Gans R, Bilo H. Improved well-being and decreased disease burden after 1-year use of flash glucose monitoring (FLARE-NL4). BMJ Open Diabetes Res Care. 2019 Dec 9;7(1):e000809. doi: 10.1136/bmjdrc-2019-000809. eCollection 2019.
- Background: PubMed 33836819Krakauer M, Botero JF, Lavalle-Gonzalez FJ, Proietti A, Barbieri DE. A review of flash glucose monitoring in type 2 diabetes. Diabetol Metab Syndr. 2021 Apr 9;13(1):42. doi: 10.1186/s13098-021-00654-3.
- Background: PubMed 33644623Bergenstal RM, Kerr MSD, Roberts GJ, Souto D, Nabutovsky Y, Hirsch IB. Flash CGM Is Associated With Reduced Diabetes Events and Hospitalizations in Insulin-Treated Type 2 Diabetes. J Endocr Soc. 2021 Feb 2;5(4):bvab013. doi: 10.1210/jendso/bvab013. eCollection 2021 Apr 1.
- Background: PubMed 31673972Evans M, Welsh Z, Ells S, Seibold A. The Impact of Flash Glucose Monitoring on Glycaemic Control as Measured by HbA1c: A Meta-analysis of Clinical Trials and Real-World Observational Studies. Diabetes Ther. 2020 Jan;11(1):83-95. doi: 10.1007/s13300-019-00720-0. Epub 2019 Oct 31.
- Background: PubMed 32487593Castellana M, Parisi C, Di Molfetta S, Di Gioia L, Natalicchio A, Perrini S, Cignarelli A, Laviola L, Giorgino F. Efficacy and safety of flash glucose monitoring in patients with type 1 and type 2 diabetes: a systematic review and meta-analysis. BMJ Open Diabetes Res Care. 2020 Jun;8(1):e001092. doi: 10.1136/bmjdrc-2019-001092.
- Background: PubMed 28000140Haak T, Hanaire H, Ajjan R, Hermanns N, Riveline JP, Rayman G. Flash Glucose-Sensing Technology as a Replacement for Blood Glucose Monitoring for the Management of Insulin-Treated Type 2 Diabetes: a Multicenter, Open-Label Randomized Controlled Trial. Diabetes Ther. 2017 Feb;8(1):55-73. doi: 10.1007/s13300-016-0223-6. Epub 2016 Dec 20.
- Background: PubMed 27634581Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FreeStyle Libre 2, flash glucose monitoring in people with Diabetes Mellitus, Type 2, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 4 inclusion and 2 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 3 Oct 2024. 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Satisfaction with the treatment (time frame: 3 months). 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 NCT06624553, which also lists 12 linked publications.
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 3 Oct 2024.