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Completed

NCT Number: NCT06624553

Satisfaction With FreeStyle Libre 2 Monitoring Versus Capillary Blood Glucose Monitoring in People With DM2

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Personal Satisfaction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Natalia Mangas Fernandez

Barcelona, 08024, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FreeStyle Libre 2, flash glucose monitoring

Device

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.

Primary outcomes

  1. Satisfaction with the treatment

    Time frame: 3 months

    Diabetes Treatment Satisfaction Questionnaire (DTSQ)

Secondary outcomes

  1. Glucometrics

    Time frame: 3 months

    In each group, assess the change in blood glucose according to your monitoring method

  2. The total number of visits

    Time frame: 3 months

    • The total number of visits (in person, by telephone and asynchronous telematics, if applicable).

  3. Number of treatment

    Time frame: 3 months

    The number of treatment changes applied to the patient.

  4. Duration of follow-up.

    Time frame: 3 months

    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

  5. HbA1c

    Time frame: Baseline and 3 months

    The hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to your hemoglobin.

  6. Perception of hiperglicemia

    Time frame: 3 months

    The value of questions 3 of the DTSQ and % of local problems as security variables.

  7. Perception of hypoglicemia

    Time frame: 3 months

    The value of questions 2 of the DTSQ and % of local problems as security variables.

Sponsors and collaborators

Lead sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Other

Registry information

Official study 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

Acronym: Diabetes type2

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 3, 2024
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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