Experience With the Use of Continuous Glucose Monitoring (CGM) Devices in People With Type 2 Diabetes Mellitus

Sponsor
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Study ID
NCT07019753
Status
Not Yet Recruiting

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Conditions

  • Continuous Glucose Monitoring
  • Patient Satisfaction
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

Background: In recent years, diabetes management has evolved with the introduction of continuous glucose monitoring (CGM) devices. Some qualitative studies have been conducted to assess the experiences of patients with type 2 diabetes mellitus (T2DM) using CGM devices, but none have been conducted in a Mediterranean country. Furthermore, there are differences in the amount of time study participants used the CGM device, ranging from 14 days to 6 months, and in some studies, participants did not receive insulin treatment. Objectives: To understand the benefits and barriers described by people with type 2 diabetes mellitus who use CGM devices through inductive thematic analysis of interviews conducted with them. Methodology: Qualitative study with a phenomenological approach and conversational technique. Adults with T2DM who have used a CGM device continuously for the past 12 months will be interviewed individually. Data analysis: They will be analyzed using inductive thematic analysis. The interviews will be transcribed verbatim, along with any relevant data collected by the other researcher present at the interview. Three researchers will then conduct a preliminary analysis, from which codes will be agreed upon and themes, categories, and subcategories will be proposed through triangulation among the researchers. This will be done inductively, through analysis, in-depth reflection, and debate among the three researchers. Applicability and relevance: Knowing the opinion of people with T2DM who use CGM devices, as well as the barriers and facilitators they find to its use will help healthcare professionals to better understand their patients and thus provide more personalised and closer healthcare. In addition, healthcare managers and administrators will be able to find out whether patients find it useful to use a CGM device, whether they reduce the use of capillary glycaemia strips, whether they become more aware of their disease and increase their self-monitoring, etc. All this will help to decide whether it is beneficial to extend the indication of these devices to more people with type 2 diabetes.

Key Dates

First listed
Jun 13, 2025
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
5 participants (estimated)

Arms

  • Arm: Type 2 diabetes and continuous glucose monitoring Tarragona
    People with T2DM and intensive insulin therapy who have used a CGM device for at least the last 12 months in the Camp de Tarragona health region.

Primary Outcome Measure

Participants' experience [ Time Frame: Last 12 months using the CGM device. ]

Central Contacts

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