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

NCT07019753 | Not Yet Recruiting

• 1 other identifier: 25/003-P
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Continuous Glucose Monitoring; Patient Satisfaction; Type 2 Diabetes Mellitus (T2DM); Quality of Life; Primary Care

Outcome Measures

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.

  Last 12 months using the CGM device.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead

Study Sites (1)

IDIAP Jordi Gol

Barcelona, Barcelona, 08007, Spain

Location

Related Publications (8)

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  PMID: 1159263 BACKGROUND

• Chiu CJ, Chou YH, Chen YJ, Du YF. Impact of New Technologies for Middle-Aged and Older Patients: In-Depth Interviews With Type 2 Diabetes Patients Using Continuous Glucose Monitoring. JMIR Diabetes. 2019 Feb 21;4(1):e10992. doi: 10.2196/10992.

  PMID: 30789351 BACKGROUND

• Shin M, Yang Y, Kang JH, Jin HY. Exploring the Initial Encounter with Continuous Glucose Monitoring among Individuals with Type 2 Diabetes: A Two-Week Trip. Diabetes Metab Syndr Obes. 2024 Sep 20;17:3521-3534. doi: 10.2147/DMSO.S466734. eCollection 2024.

  PMID: 39319303 BACKGROUND

• Johansson UB, Andreassen Gleissman S, Korkeila Liden M, Wickman M, Gustafsson B, Sjoberg S. Mixed methods study on the feasibility of implementing periodic continuous glucose monitoring among individuals with type 2 diabetes mellitus in a primary care setting. Heliyon. 2024 Apr 16;10(8):e29498. doi: 10.1016/j.heliyon.2024.e29498. eCollection 2024 Apr 30.

  PMID: 38660249 BACKGROUND

• Allen NA, Jacelon CS, Chipkin SR. Feasibility and acceptability of continuous glucose monitoring and accelerometer technology in exercising individuals with type 2 diabetes. J Clin Nurs. 2009 Feb;18(3):373-83. doi: 10.1111/j.1365-2702.2008.02533.x.

  PMID: 19191984 BACKGROUND

• 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.

  PMID: 38932793 BACKGROUND

• Hirsch IB. Introduction: History of Glucose Monitoring. In: Role of Continuous Glucose Monitoring in Diabetes Treatment. Arlington (VA): American Diabetes Association; 2018 Aug. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK538968/

  PMID: 34251770 BACKGROUND

• 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.

  PMID: 36561654 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sergi Rodríguez-Soler, Nurse

  Institut Català de la Salut

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergi Rodríguez-Soler, Nurse

CONTACT

34+ 682251783; ssrodriguez.tgn.ics@gencat.cat

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: June 13, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

ES (1)