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Not yet recruitingNCT07019753GlucocaviUpdated Aug 25, 2026

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

An observational study in Patient Satisfaction, Continuous Glucose Monitoring and Type 2 Diabetes Mellitus (T2DM), sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.

Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
5
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Patient Satisfaction

877 studies on the registry are indexed under Patient Satisfaction; 202 are open to participants now.

This study's planned enrollment of 5 is below the median of 149 across 225 observational studies indexed under Patient Satisfaction.

Browse Patient Satisfaction studies →

Lead sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina is the lead sponsor of 161 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
5 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

07

Study locations

1 site
08

References and documents

Publications

  • 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/ PubMed 34251770 ↗
  • Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc. 1975 Oct;23(10):433-41. doi: 10.1111/j.1532-5415.1975.tb00927.x. PubMed 1159263 ↗
  • 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. PubMed 30789351 ↗
  • 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. PubMed 39319303 ↗
  • 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. PubMed 38660249 ↗
  • 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. PubMed 19191984 ↗
  • 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. PubMed 38932793 ↗
  • 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. PubMed 36561654 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Oct 2026, 0 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 26, 2025
First posted
Jun 13, 2025
StartEst.
Oct 2026
Primary completionEst.
Oct 31, 2026
CompletionEst.
Oct 31, 2026
Last update
Aug 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07019753
Responsible party
Sergi Rodríguez Soler (Principal Investigator, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina) — Principal investigator
First posted
Jun 13, 2025
Start date
Oct 2026 (estimated)
Primary completion
Oct 31, 2026 (estimated)
Completion
Oct 31, 2026 (estimated)
Last update
Aug 25, 2026

Study contacts

Sergi Rodríguez-Soler, Nurse
Contact
ssrodriguez.tgn.ics@gencat.cat
34+ 682251783
Sergi Rodríguez-Soler, Nurse
principal investigator · Institut Català de la Salut

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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