Continuous Glucose MonitoringGlucocaviNCT06716671
Influence of Continuous Glucose Monitoring on Quality of Life in People With Type 2 Diabetes Mellitus
An observational study of Continuous Glucose Monitoring and Quality of Life, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
Background: Diabetes Mellitus (DM) is a chronic disease that affects millions of people worldwide. More than 95% of cases are type 2 diabetes mellitus (T2DM). In recent years, diabetes management has evolved with the introduction of continuous glucose monitoring (CGM) devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Glucose Monitoring, Quality of Life, Type 2 Diabetes Mellitus (T2DM)
- How many people
- 87 participants
- Where
- 1 siteSpain
- Study dates
- 4 Sep 2024to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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: The study population is adults in an industrialised country with a diagnosis of type 2 diabetes with intensive insulin regimen who will start using a CGM sensor. 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
- Treatment with intensive insulin therapy (basal bolus regimen with 3 or more daily doses of insulin).
- Perform 6 or more daily capillary glycaemia determinations.
- Be willing to use a CGM device for at least 70% of the time.
- Undergo training on the use of the CGM device by the centre's CGM referent.
- Agree to participate in the study.
Who cannot join
- Cognitive impairment measured by Pfeiffer test with a score of 3 or more errors.
- Previous use of a CGM device.
- Pregnancy.
- Being institutionalised.
- Having participated in another research study related to diabetes mellitus within the last year.
- Not having proper handling of the CGM device: inability to download glycaemic control data, inability to keep the sensor attached to the skin, not understanding how it works, etc.
Trial locations and contacts
1 site in 1 country.
About this study
Background: Diabetes Mellitus (DM) is a chronic disease that affects millions of people worldwide. More than 95% of cases are type 2 diabetes mellitus (T2DM). In recent years, diabetes management has evolved with the introduction of continuous glucose monitoring (CGM) devices. These devices implanted under the skin 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. While studies demostrate the effectiveness of CGM devices in controlling glucose levels in adults with T2DM, there is no evidence related to quality of life in this patients.
Hypothesis: The use of CGM in people with T2DM improves their quality of life, reduces distress about the disease, reduces fear of hypoglycaemia, increases detection of hypoglycaemia, and improves metabolic control.
Read more
Objectives: To assess quality of life, diabetes distress, fear of hypoglycaemia, detection of hypoglycaemia, and metabolic control in people with T2DM before and after the use of CGM sensors.
Methodology: Prospective observational pre-post unblinded study. Adults with type 2 diabetes using a CGM device in the primary care setting will be followed for 12 months. They will be asked to complete 5 questionnaires at baseline, and 4 questionnaires at 3, 6 and 12 months. No other activity that differs from usual clinical practice will be performed.
Data analysis: a descriptive analysis of the main study variables will be carried out and the differences in the data before and after the intervention will be analysed using the chi-square test for qualitative variables, and the Student's t-test for quantitative variables. Statistical significance will be accepted at a p-value < 0.05.
Applicability and relevance: The results of the study will provide information on whether CGM devices improve quality of life and glycaemic control in people with type 2 diabetes. With these results it will be possible to assess whether it is beneficial to extend funding for CGM devices to more of the population than is currently the case.
Read the detailed description
Study development: The recruitment period runs from September 2024 to February 2025. 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. Sampling will be by convenience, all persons who meet the inclusion criteria and none of the exclusion criteria will be offered to participate in the study. Participants must sign an informed consent and their data will be coded.
Participants will be asked to fill in 5 questionnaires at the beginning of the study:
- Sociodemographic questionnaire created ad hoc to know the profile of the patients.
- EsDQOL questionnaire that assesses the quality of life related to diabetes.
- DDS17 questionnaire that assesses diabetes-related distress.
- EsHFS questionnaire that assesses fear of hypoglycaemia.
- Clarke Test that assesses the detection of hypoglycaemia.
The EsDQOL, DDS17, EsHFS and Clarke Test questionnaires must be repeated at 3, 6 and 12 months after the start of the study. Participants will be called to their primary care centre of reference to fill in the questionnaires themselves and these will be kept on paper at the centre until data analysis.
To assess metabolic control, the data provided by the CGM sensor will be used and the results of the AGP (Ambulatory Glucose Profile) report of the first 2 weeks will be compared with the data at 3, 6 and 12 months. No analytical tests or capillary blood glucose measurements will be requested.
Data analysis: A descriptive analysis of the main study variables will be performed using percentages for qualitative variables and mean and standard deviation for quantitative variables. To analyse the differences in the data before and after the intervention, chi-square tests will be used for qualitative variables and the Student's t-test for quantitative variables. Statistical significance will be accepted with a p-value <0.05. Data will be analysed using SPSS statistical software version 23 or later.
Sample calculation: Accepting an alpha risk of 0.05 and a statistical power greater than 0.8 in a bilateral contrast, 55 subjects are required to detect as statistically significant a difference equal to or greater than 9 units in the EsDQOL questionnaire (main study variable). A common standard deviation of 23.65 is estimated. A loss to follow-up rate of 0% is estimated. [GRANMO sample size calculator v7.10 available at Calculator (laalamedilla.org)].
- Keywords
- Continuous Glucose Monitoring, Quality of Life, Primary Care, Hypoglycemia, Type 2 Diabetes Mellitus, Patient satisfaction
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia, Patient Satisfaction
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 type 2 diabetes and intensive insulin therapy who are using a continuous glucose monitoring sensor for the first time in the Camp de Tarragona health region. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between pre and post "diabetes-related quality of life (EsDQOL)" questionnaire.
A validated scale is used to measure diabetes-related quality of life. It consists of 43 questions with answers on a Likert scale from 1 to 5. The higher the score, the worse the quality of life.
Measured: 0, 3, 6 and 12 months
Secondary outcomes (4)
Difference between pre and post "diabetes-related distress scale (DDS17)".
A validated scale is used to measure diabetes-related distress. It consists of 17 questions with answers on a Likert scale from 1 to 6. An average score < 2 points is considered normal, moderate distress a score between 2.0 and 2.9 points, and high distress a score equal to or higher than 3.
Measured: 0, 3, 6 and 12 months
Difference between pre and post "hypoglycaemia fear test (EsHFS)".
A validated scale is used to measure the hypoglycaemia fear. It consists of 24 questions with answers on a Likert scale from 1 to 5. The higher the score, the greater the fear of hypoglycaemia.
Measured: 0, 3, 6 and 12 months
Difference between pre and post "undetected hypoglycemia test (Test de Clarke)".
A validated test that assesses the patient's ability to detect hypoglycaemia. Each response is classified as normal or abnormal. If the sum total of abnormal responses is ≥4, the patient has an abnormal perception of hypoglycaemia, 3 abnormal responses is considered undetermined, and 2 or less is considered normal perception.
Measured: 0, 3, 6 and 12 months
Difference between pre and post metabolic control.
The CGM sensor provides several metabolic control values: % time glucose in range (70-180mg/dl), % time between 70mg/dl and 54mg/dl, % time below 54mg/dl, % time between 180mg/dl and 250mg/dl, % time above 250mg/dl, average glucose, glucose management indicator (GMI), and glucose variability (%CV). Data from the patient's first AGP report 2 weeks after starting to use the CGM sensor will be compared with data at 3, 6 and 12 months.
Measured: 2 weeks, 3 months, 6 months, 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start4 Sep 2024
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Continuous Glucose MonitoringStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
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
- NCT06716671
- Sponsor's protocol ID
- 24/166-P
- Acronym
- Glucocavi
- Status last verified
- Aug 2026
- First submitted
- 29 Nov 2024
- 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 34251770Chesser H, Srinivasan S, Puckett C, Gitelman SE, Wong JC. Real-Time Continuous Glucose Monitoring in Adolescents and Young Adults With Type 2 Diabetes Can Improve Quality of Life. J Diabetes Sci Technol. 2024 Jul;18(4):911-919. doi: 10.1177/19322968221139873. Epub 2022 Nov 23.
PubMed 36416098Moreno-Fernandez J, Gomez FJ, Galvez Moreno MA, Castano JP. Clinical Efficacy of Two Different Methods to Initiate Sensor-Augmented Insulin Pumps: A Randomized Controlled Trial. J Diabetes Res. 2016;2016:4171789. doi: 10.1155/2016/4171789. Epub 2016 Nov 29.
PubMed 28004007Gilbert TR, Noar A, Blalock O, Polonsky WH. Change in Hemoglobin A1c and Quality of Life with Real-Time Continuous Glucose Monitoring Use by People with Insulin-Treated Diabetes in the Landmark Study. Diabetes Technol Ther. 2021 Mar;23(S1):S35-S39. doi: 10.1089/dia.2020.0666.
PubMed 33470882Gehlaut RR, Dogbey GY, Schwartz FL, Marling CR, Shubrook JH. Hypoglycemia in Type 2 Diabetes--More Common Than You Think: A Continuous Glucose Monitoring Study. J Diabetes Sci Technol. 2015 Apr 27;9(5):999-1005. doi: 10.1177/1932296815581052.
PubMed 25917335Rodriguez de Vera Gomez P, Mateo Rodriguez C, Rodriguez Jimenez B, Hidalgo Sotelo L, Peinado Ruiz M, Torrecillas Del Castillo E, Ruiz-Aranda D, Serrano Olmedo I, Candau Martin A, Martinez-Brocca MA. Impact of Flash Glucose Monitoring on the Fear of Hypoglycemia Phenomenon in Adults with Type 1 Diabetes. Diabetes Technol Ther. 2024 Jul;26(7):478-487. doi: 10.1089/dia.2023.0370. Epub 2024 Feb 22.
PubMed 38315507Charleer S, Mathieu C, Nobels F, De Block C, Radermecker RP, Hermans MP, Taes Y, Vercammen C, T'Sjoen G, Crenier L, Fieuws S, Keymeulen B, Gillard P; RESCUE Trial Investigators. Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1224-1232. doi: 10.1210/jc.2017-02498.
PubMed 29342264Rodbard D. Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes. Diabetes Technol Ther. 2017 Jun;19(S3):S25-S37. doi: 10.1089/dia.2017.0035.
PubMed 28585879Kieu A, King J, Govender RD, Ostlundh L. The Benefits of Utilizing Continuous Glucose Monitoring of Diabetes Mellitus in Primary Care: A Systematic Review. J Diabetes Sci Technol. 2023 May;17(3):762-774. doi: 10.1177/19322968211070855. Epub 2022 Feb 1.
PubMed 35100891McGill JB, Ahmann A. Continuous Glucose Monitoring with Multiple Daily Insulin Treatment: Outcome Studies. Diabetes Technol Ther. 2017 Jun;19(S3):S3-S12. doi: 10.1089/dia.2017.0090.
PubMed 28585875
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
- Influence of Continuous Glucose Monitoring on Quality of Life in People With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06716671
- Acronym / sponsor ID
- Glucocavi / 24/166-P
- Keywords
- Continuous Glucose Monitoring, Quality of Life, Primary Care, Hypoglycemia, Type 2 Diabetes Mellitus, Patient satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 4 Dec 2024 (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: Diabetes Mellitus (DM) is a chronic disease that affects millions of people worldwide. More than 95% of cases are type 2 diabetes mellitus (T2DM). In recent years, diabetes management has evolved with the introduction of continuous glucose monitoring (CGM) devices. These devices implanted under the skin 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. While studies demostrate the effectiveness of CGM devices in controlling glucose levels in adults with T2DM, there is no evidence related to quality of life in this patients.
Hypothesis: The use of CGM in people with T2DM improves their quality of life, reduces distress about the disease, reduces fear of hypoglycaemia, increases detection of hypoglycaemia, and improves metabolic control.
Objectives: To assess quality of life, diabetes distress, fear of hypoglycaemia, detection of hypoglycaemia, and metabolic control in people with T2DM before and after the use of CGM sensors.
Methodology: Prospective observational pre-post unblinded study. Adults with type 2 diabetes using a CGM device in the primary care setting will be followed for 12 months. They will be asked to complete 5 questionnaires at baseline, and 4 questionnaires at 3, 6 and 12 months. No other activity that differs from usual clinical practice will be performed.
Data analysis: a descriptive analysis of the main study variables will be carried out and the differences in the data before and after the intervention will be analysed using the chi-square test for qualitative variables, and the Student's t-test for quantitative variables. Statistical significance will be accepted at a p-value < 0.05.
Applicability and relevance: The results of the study will provide information on whether CGM devices improve quality of life and glycaemic control in people with type 2 diabetes. With these results it will be possible to assess whether it is beneficial to extend funding for CGM devices to more of the population than is currently the case.
Detailed description
Study development: The recruitment period runs from September 2024 to February 2025. 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. Sampling will be by convenience, all persons who meet the inclusion criteria and none of the exclusion criteria will be offered to participate in the study. Participants must sign an informed consent and their data will be coded.
Participants will be asked to fill in 5 questionnaires at the beginning of the study:
- Sociodemographic questionnaire created ad hoc to know the profile of the patients.
- EsDQOL questionnaire that assesses the quality of life related to diabetes.
- DDS17 questionnaire that assesses diabetes-related distress.
- EsHFS questionnaire that assesses fear of hypoglycaemia.
- Clarke Test that assesses the detection of hypoglycaemia.
The EsDQOL, DDS17, EsHFS and Clarke Test questionnaires must be repeated at 3, 6 and 12 months after the start of the study. Participants will be called to their primary care centre of reference to fill in the questionnaires themselves and these will be kept on paper at the centre until data analysis.
To assess metabolic control, the data provided by the CGM sensor will be used and the results of the AGP (Ambulatory Glucose Profile) report of the first 2 weeks will be compared with the data at 3, 6 and 12 months. No analytical tests or capillary blood glucose measurements will be requested.
Data analysis: A descriptive analysis of the main study variables will be performed using percentages for qualitative variables and mean and standard deviation for quantitative variables. To analyse the differences in the data before and after the intervention, chi-square tests will be used for qualitative variables and the Student's t-test for quantitative variables. Statistical significance will be accepted with a p-value <0.05. Data will be analysed using SPSS statistical software version 23 or later.
Sample calculation: Accepting an alpha risk of 0.05 and a statistical power greater than 0.8 in a bilateral contrast, 55 subjects are required to detect as statistically significant a difference equal to or greater than 9 units in the EsDQOL questionnaire (main study variable). A common standard deviation of 23.65 is estimated. A loss to follow-up rate of 0% is estimated. [GRANMO sample size calculator v7.10 available at Calculator (laalamedilla.org)].
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes and continuous glucose monitoring Tarragona | – | –People with type 2 diabetes and intensive insulin therapy who are using a continuous glucose monitoring sensor for the first time 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
- The study population is adults in an industrialised country with a diagnosis of type 2 diabetes with intensive insulin regimen who will start using a CGM sensor. 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 (5 listed)
- Treatment with intensive insulin therapy (basal bolus regimen with 3 or more daily doses of insulin).
- Perform 6 or more daily capillary glycaemia determinations.
- Be willing to use a CGM device for at least 70% of the time.
- Undergo training on the use of the CGM device by the centre's CGM referent.
- Agree to participate in the study.
Key exclusion criteria (6 listed)
- Cognitive impairment measured by Pfeiffer test with a score of 3 or more errors.
- Previous use of a CGM device.
- Pregnancy.
- Being institutionalised.
- Having participated in another research study related to diabetes mellitus within the last year.
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
Difference between pre and post "diabetes-related quality of life (EsDQOL)" questionnaire.
Time frame: 0, 3, 6 and 12 months
A validated scale is used to measure diabetes-related quality of life. It consists of 43 questions with answers on a Likert scale from 1 to 5. The higher the score, the worse the quality of life.
4 secondary outcomes
Difference between pre and post "diabetes-related distress scale (DDS17)".
Time frame: 0, 3, 6 and 12 months
Difference between pre and post "hypoglycaemia fear test (EsHFS)".
Time frame: 0, 3, 6 and 12 months
Difference between pre and post "undetected hypoglycemia test (Test de Clarke)".
Time frame: 0, 3, 6 and 12 months
Difference between pre and post metabolic control.
Time frame: 2 weeks, 3 months, 6 months, 12 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 36416098Chesser H, Srinivasan S, Puckett C, Gitelman SE, Wong JC. Real-Time Continuous Glucose Monitoring in Adolescents and Young Adults With Type 2 Diabetes Can Improve Quality of Life. J Diabetes Sci Technol. 2024 Jul;18(4):911-919. doi: 10.1177/19322968221139873. Epub 2022 Nov 23.
- Results publication: PubMed 28004007Moreno-Fernandez J, Gomez FJ, Galvez Moreno MA, Castano JP. Clinical Efficacy of Two Different Methods to Initiate Sensor-Augmented Insulin Pumps: A Randomized Controlled Trial. J Diabetes Res. 2016;2016:4171789. doi: 10.1155/2016/4171789. Epub 2016 Nov 29.
- Results publication: PubMed 33470882Gilbert TR, Noar A, Blalock O, Polonsky WH. Change in Hemoglobin A1c and Quality of Life with Real-Time Continuous Glucose Monitoring Use by People with Insulin-Treated Diabetes in the Landmark Study. Diabetes Technol Ther. 2021 Mar;23(S1):S35-S39. doi: 10.1089/dia.2020.0666.
- Results publication: PubMed 25917335Gehlaut RR, Dogbey GY, Schwartz FL, Marling CR, Shubrook JH. Hypoglycemia in Type 2 Diabetes--More Common Than You Think: A Continuous Glucose Monitoring Study. J Diabetes Sci Technol. 2015 Apr 27;9(5):999-1005. doi: 10.1177/1932296815581052.
- Results publication: PubMed 38315507Rodriguez de Vera Gomez P, Mateo Rodriguez C, Rodriguez Jimenez B, Hidalgo Sotelo L, Peinado Ruiz M, Torrecillas Del Castillo E, Ruiz-Aranda D, Serrano Olmedo I, Candau Martin A, Martinez-Brocca MA. Impact of Flash Glucose Monitoring on the Fear of Hypoglycemia Phenomenon in Adults with Type 1 Diabetes. Diabetes Technol Ther. 2024 Jul;26(7):478-487. doi: 10.1089/dia.2023.0370. Epub 2024 Feb 22.
- Results publication: PubMed 29342264Charleer S, Mathieu C, Nobels F, De Block C, Radermecker RP, Hermans MP, Taes Y, Vercammen C, T'Sjoen G, Crenier L, Fieuws S, Keymeulen B, Gillard P; RESCUE Trial Investigators. Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study. J Clin Endocrinol Metab. 2018 Mar 1;103(3):1224-1232. doi: 10.1210/jc.2017-02498.
- Results publication: PubMed 28585879Rodbard D. Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes. Diabetes Technol Ther. 2017 Jun;19(S3):S25-S37. doi: 10.1089/dia.2017.0035.
- Results publication: PubMed 35100891Kieu A, King J, Govender RD, Ostlundh L. The Benefits of Utilizing Continuous Glucose Monitoring of Diabetes Mellitus in Primary Care: A Systematic Review. J Diabetes Sci Technol. 2023 May;17(3):762-774. doi: 10.1177/19322968211070855. Epub 2022 Feb 1.
- Results publication: PubMed 28585875McGill JB, Ahmann A. Continuous Glucose Monitoring with Multiple Daily Insulin Treatment: Outcome Studies. Diabetes Technol Ther. 2017 Jun;19(S3):S3-S12. doi: 10.1089/dia.2017.0090.
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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. This study is not recruiting at the moment.
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 Continuous Glucose Monitoring and Quality of Life, 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 5 inclusion and 6 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between pre and post "diabetes-related quality of life (EsDQOL)" questionnaire. (time frame: 0, 3, 6 and 12 months). 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 NCT06716671, which also lists 10 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.