Clinical trial NCT06624553: Satisfaction With FreeStyle Libre 2 Monitoring Versus Capillary Blood Glucose Monitoring in People With DM2
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: diabetes
glucose monitoring
satisfaction
diabetes technology
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DEVICE_FEASIBILITY

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Satisfaction with the treatment
timeFrame: 3 months
Secondary outcomes:
measure: Glucometrics
timeFrame: 3 months
measure: The total number of visits
timeFrame: 3 months
measure: Number of treatment
timeFrame: 3 months
measure: Duration of follow-up.
timeFrame: 3 months
measure: HbA1c
timeFrame: Baseline and 3 months
measure: Perception of hiperglicemia
timeFrame: 3 months
measure: Perception of hypoglicemia
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Natalia Mangas Fernandez
Study officials:
References:
citation: 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.
citation: American 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.
citation: Saisho 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.
citation: Martens 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.
citation: Diez-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.
citation: Fokkert 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.
citation: Krakauer 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.
citation: Bergenstal 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.
citation: Evans 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.
citation: Castellana 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.
citation: Haak 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.
citation: Bolinder 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.