Patient SatisfactionGlucocaviNCT07019753
Experience With the Use of Continuous Glucose Monitoring (CGM) Devices in People With Type 2 Diabetes Mellitus
An observational study of Patient Satisfaction and Continuous Glucose Monitoring, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Satisfaction, Continuous Glucose Monitoring, Type 2 Diabetes Mellitus (T2DM)
- How many people
- 5 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2026to 31 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
IDIAP Jordi Gol
Barcelona, Barcelona, 08007
Cristina Rey-Reñones, PhD, 34+ 977778515 ext. 405, crey.tgn.ics@gencat.cat
Sergi Rodríguez-Soler, Nurse, 34+ 682251783, ssrodriguez.tgn.ics@gencat.cat
About this study
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.
Read more
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.
- Keywords
- Continuous Glucose Monitoring, Patient Satisfaction, Type 2 Diabetes Mellitus (T2DM), Quality of Life, Primary Care
- Medical subject headings
- Patient Satisfaction, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Last 12 months using the CGM device.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study startOct 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Patient SatisfactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergi Rodríguez Soler, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Investigators
- Sergi Rodríguez-Soler, Nurse, Principal investigator, Institut Català de la Salut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019753
- Sponsor's protocol ID
- 25/003-P
- Acronym
- Glucocavi
- Status last verified
- Aug 2026
- First submitted
- 26 Apr 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 34251770Pfeiffer 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 1159263Chiu 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 30789351Shin 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 39319303Johansson 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 38660249Allen 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 19191984Sergel-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 38932793Litchman 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experience With the Use of Continuous Glucose Monitoring (CGM) Devices in People With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07019753
- Acronym / sponsor ID
- Glucocavi / 25/003-P
- Keywords
- Continuous Glucose Monitoring, Patient Satisfaction, Type 2 Diabetes Mellitus (T2DM), Quality of Life, Primary Care
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participants' experience
Time frame: Last 12 months using the CGM device.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 34251770Hirsch 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/
- Results publication: PubMed 1159263Pfeiffer 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.
- Results publication: PubMed 30789351Chiu 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.
- Results publication: PubMed 39319303Shin 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.
- Results publication: PubMed 38660249Johansson 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.
- Results publication: PubMed 19191984Allen 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.
- Results publication: PubMed 38932793Sergel-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.
- Results publication: PubMed 36561654Litchman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sergi Rodríguez-Soler, Nurse principal investigator
Institut Català de la Salut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Satisfaction and Continuous Glucose Monitoring, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergi Rodríguez-Soler, Nurse (34+ 682251783, ssrodriguez.tgn.ics@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' experience (time frame: Last 12 months using the CGM device.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07019753, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.