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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have been using a CGM sensor daily for diabetes management for the past 12 months or more.

Treatment with intensive insulin therapy (basal bolus regimen with 3 or more daily doses of insulin).

Agree to participate in the study.

Disqualifiers

Cognitive impairment measured by the SPMSQ test with a score of 3 or more errors.

Being institutionalised.

Have another person responsible for monitoring the device and making decisions related to diabetes (insulin adjustment, carbohydrate rations, etc.).

Language difficulty: not being able to hold a fluent conversation in Catalan or Spanish for 30-60 minutes.

Trial population

Adults in an industrialised country with a diagnosis of type 2 diabetes with intensive insulin regimen who have used a CGM device for at least the last 12 months. Participants will be recruited from primary care centres in the Camp de Tarragona health region following inclusion and exclusion criteria. Depending on the location of the primary care centre, the population may be from an urban, semi-urban, or rural setting.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

5 Participants
are grouped into 1 trial group
Group A: Type 2 diabetes and continuous glucose monitoring Tarragona

Trial outcomes

Primary outcomes

1

Participants' experience

The themes, categories, and subcategories that emerge from the analysis of each interview will be compared with those of the other participants to determine what similarities and contrasts exist.

Time frame
Last 12 months using the CGM device.

Secondary outcomes

Other outcomes

Sponsors and contacts

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