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

NCT ID: NCT07019753

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-10-31

Brief Summary

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.

Detailed Description

Background: Diabetes mellitus is a chronic disease that affects millions of people worldwide. More than 95% of cases are T2DM. The CGM devices are attached to the skin and allow continuous measurement of glucose levels, monitoring glucose trends, and the rate at which glucose level rise and fall without the need for capillary glycaemias test, making glycemic control easier for people with diabetes.

Study development: The recruitment period runs from January 2026 to April 2026. Opinion sampling will be conducted. Participants will be recruited by health professionals (nurse or doctor) CGM referents from each of the 20 primary care centres in the Camp de Tarragona health region. They will explain the study and will invite all people who meet all the inclusion criteria and none of the exclusion criteria to participate in the study.

The principal investigator will select between 5 and 10 participants from those preselected by the CGM referents, taking into account the sample's diverse profiles: age, gender, years of diabetes evolution, metabolic control, etc.

Interviews will last between 30 and 60 minutes, and interviews will continue until data saturation is reached (anticipated between 5 and 10).

Participants must sign an informed consent and their data will be coded.

Data analysis: In order to facilitate the inductive analysis of the interview data, the ATLAS-TI software (version 8 or later) will be used.

Conditions

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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role: lead

Responsible Party

Sergi Rodríguez Soler

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergi Rodríguez-Soler, Nurse

Role: PRINCIPAL_INVESTIGATOR

Institut Català de la Salut

Locations

IDIAP Jordi Gol

Barcelona, Barcelona, Spain

Countries

Spain

Central Contacts

Sergi Rodríguez-Soler, Nurse

Role: CONTACT

ssrodriguez.tgn.ics@gencat.cat

34+ 682251783

Facility Contacts

Cristina Rey-Reñones, PhD

Role: primary

crey.tgn.ics@gencat.cat

34+ 977778515 ext. 405

Sergi Rodríguez-Soler, Nurse

Role: backup

ssrodriguez.tgn.ics@gencat.cat

34+ 682251783

References

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Reference Type: BACKGROUND

PMID: 30789351 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Sergel-Stringer OT, Wheeler BJ, Styles SE, Boucsein A, Lever CS, Paul RG, Sampson R, Watson A, de Bock MI. Acceptability and experiences of real-time continuous glucose monitoring in adults with type 2 diabetes using insulin: a qualitative study. J Diabetes Metab Disord. 2024 Mar 5;23(1):1163-1171. doi: 10.1007/s40200-024-01403-9. eCollection 2024 Jun.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 34251770 (View on PubMed)

Litchman ML, Allen NA, Sanchez-Birkhead A, Ng A, Rodriguez-Gonzales B, Iacob E, Greenwood DA. Continuous Glucose Monitoring Plus an Online Peer Support Community Reinforces Healthy Behaviors in Hispanic Adults With Type 2 Diabetes. Diabetes Spectr. 2022 Fall;35(4):452-460. doi: 10.2337/ds21-0067. Epub 2022 Mar 28.

Reference Type: BACKGROUND

PMID: 36561654 (View on PubMed)

Other Identifiers

25/003-P

Identifier Type: -

Identifier Source: org_study_id