Glucose Metabolism Disorders in Cystic FibrosisCGMUCODIABNCT07851831
Reproducibility of Continuous Glucose Monitoring (CGM) in the Assessment of Glucose Metabolism Disorders in Children With Cystic Fibrosis
A study testing Continuous Glucose Monitoring, Eating Habits Questionnaire and Use of an actigraphy watch in people with Glucose Metabolism Disorders in Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Glucose metabolism disorders in cystic fibrosis (CF-GMD) are common and have a negative clinical impact. Screening currently relies on the oral glucose tolerance test (OGTT); however, this procedure is burdensome and complex for both patients and healthcare providers. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Glucose Metabolism Disorders in Cystic Fibrosis
- What is being tested?
- Continuous Glucose Monitoring, Eating Habits Questionnaire and Use of an actigraphy watch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2026to May 2028
- Phase
- Interventional
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 10 to 17 years
- Diagnosed with cystic fibrosis (CF)
- Managed by the pediatric CF care center (CRCM) of the Groupement Hospitalier Est
- Patients presenting with one of the following three stages are included: normal glucose tolerance with or without indeterminate glucose tolerance (INDET), impaired fasting glucose (IFG), and impaired glucose tolerance (IGT)
Who cannot join
- Patients with treated or untreated diabetes
- Patients presenting with a pulmonary exacerbation and currently receiving antibiotic therapy
- Patients participating in another clinical trial that could interfere, in the investigator's judgment, with the study findings
- Refusal of the patient and/or the legal guardian(s) to participate in the study
- Pregnant, parturient, or breastfeeding women
- Persons deprived of liberty by a judicial or administrative decision
Show all 9Show fewer
- Persons undergoing psychiatric care
- Persons admitted to a healthcare or social institution for purposes other than research
- Persons not affiliated with a social security scheme or beneficiaries of a similar scheme
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Hôpital Femme Mère Enfant (HFME)
Bron, 69677
Philippe REIX, Prof, 04 27 85 54 70 ext. +33, philippe.reix@chu-lyon.fr
About this study
Glucose metabolism disorders in cystic fibrosis (CF-GMD) are common and have a negative clinical impact. Screening currently relies on the oral glucose tolerance test (OGTT); however, this procedure is burdensome and complex for both patients and healthcare providers. Continuous glucose monitoring (CGM) is increasingly used in CF centers for CF-GMD screening, either alone or alongside the OGTT. While long-term (one-year) OGTT reproducibility is known to be poor, the short- and medium-term reproducibility of CGM remains unknown. This examination is poised to become a major tool in CF-GMD investigation, upon which critical therapeutic decisions could be based. The primary objective of this project is to evaluate the short-term variability of CGM data.
- Being tested
- Continuous Glucose Monitoring, Eating Habits Questionnaire, Use of an actigraphy watch
- Keywords
- Cystic Fibrosis, Glucose metabolism disorders, Continuous Glucose Monitoring
- Medical subject headings
- Cystic Fibrosis, Glucose Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitoringDevice
Upon enrollment, patients will be equipped with a continuous glucose monitoring (CGM) sensor (Dexcom ONE+). Sensors will be placed on the posterior aspect of the dominant arm at M0, M3, and M6, and additionally on the non-dominant arm at M0 only, in order to evaluate site-dependent variability. At each time point, the sensors will be worn for 7 days to record various CGM parameters, including glycemic variability (analyzed between M0-M3 and M0-M6).
Eating Habits QuestionnaireOther
A 7-day dietary diary will be completed at M0, M3, and M6.
Use of an actigraphy watchOther
Participants will wear an actigraphy watch during 7 days at M0, M3 and M6
| Study group | Role | What they receive |
|---|---|---|
| Non-diabetic patient with cystic fibrosis | Experimental | Children aged 10 to 17 years diagnosed with cystic fibrosis (CF). Patients presenting with one of the following three stages are included: normal glucose tolerance with or without indeterminate glucose tolerance (INDET), impaired fasting glucose (IFG), and impaired glucose tolerance (IGT).
Patients will be equipped with a continuous glucose monitoring (CGM) sensor (Dexcom ONE+). Receives: Device: Continuous Glucose Monitoring; Other: Eating Habits Questionnaire; Other: Use of an actigraphy watch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
Measured: From enrollment to 3 months
Secondary outcomes (29)
The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
Measured: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: percentage of time in hyperglycemia (>140 mg/dL)
The variability of other CGM parameters between M0 and M3: percentage of time in hyperglycemia (>140 mg/dL)
Measured: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: glycemic variability (%)
The variability of other CGM parameters between M0 and M3: glycemic variability (%)
Measured: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: mean glucose level (mg/dL)
The variability of other CGM parameters between M0 and M3: mean glucose level (mg/dL)
Measured: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: number of glucose excursions >200 mg/dL
The variability of other CGM parameters between M0 and M3: number of glucose excursions >200 mg/dL
Measured: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: estimated HbA1c (eA1c)
The variability of other CGM parameters between M0 and M3: estimated HbA1c (eA1c)
Measured: From enrollment to 3 months
The variability of CGM parameters between M0 and M6: "time in range" (%) (70-140 mg/dL)
The variability of CGM parameters between M0 and M6: "time in range" (%) (70-140 mg/dL)
Measured: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: percentage of time in hypoglycemia (<70 mg/dL),
The variability of CGM parameters between M0 and M6: percentage of time in hypoglycemia (<70 mg/dL),
Measured: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: percentage of time in hyperglycemia (>140 mg/dL),
The variability of CGM parameters between M0 and M6: percentage of time in hyperglycemia (>140 mg/dL),
Measured: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: glycemic variability (%),
The variability of CGM parameters between M0 and M6: glycemic variability (%),
Measured: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: mean glucose level (mg/dL),
The variability of CGM parameters between M0 and M6: mean glucose level (mg/dL),
Measured: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: number of glucose excursions >200 mg/dL
The variability of CGM parameters between M0 and M6: number of glucose excursions >200 mg/dL
Measured: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: estimated HbA1c (eA1c)
The variability of CGM parameters between M0 and M6: estimated HbA1c (eA1c)
Measured: From enrollment to 6 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): "time in range" (%) (70-140 mg/dL)
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): "time in range" (%) (70-140 mg/dL)
Measured: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hypoglycemia (<70 mg/dL),
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hypoglycemia (<70 mg/dL),
Measured: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hyperglycemia (>180 mg/dL)
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hyperglycemia (>180 mg/dL)
Measured: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): glycemic variability (%)
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): glycemic variability (%)
Measured: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): mean glucose level (mg/dL)
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): mean glucose level (mg/dL)
Measured: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): number of glucose excursions >200 mg/dL
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): number of glucose excursions >200 mg/dL
Measured: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): estimated HbA1c (eA1c)
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): estimated HbA1c (eA1c)
Measured: From enrollment to 3 months
The variability of CGM parameters according to physical activity (percentage of daytime activity) : Variation in the number of steps
The variability of CGM parameters according to physical activity (percentage of daytime activity), Variation in the number of steps
Measured: From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition (body fat percentage)
The variability of CGM parameters according to body composition (body fat percentage) : body fat in kg
Measured: From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition
The variability of CGM parameters according to body composition (lean mass percentage) : body fat in kg
Measured: From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition (fat mass percentage in the dominant arm)
The variability of CGM parameters according to body composition (fat mass percentage in the dominant arm) : body fat in kg
Measured: From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition (fat mass percentage in the non-dominant arm) : body fat in kg
The variability of CGM parameters according to body composition (fat mass percentage in the non-dominant arm) : body fat in kg
Measured: From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : Daily nutritional intake (kcal)
The variability of CGM parameters according to nutritional intake : Daily nutritional intake (kcal)
Measured: From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : carbohydrates (kg)
The variability of CGM parameters according to nutritional intake : carbohydrates (kg)
Measured: From enrollment to 3 months ans 6 months
The variability of CGM parameters according to nutritional intake : fats (kg)
The variability of CGM parameters according to nutritional intake : fats (kg)
Measured: From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : proteins (kg)
The variability of CGM parameters according to nutritional intake : proteins (kg)
Measured: From enrollment to 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism Disorders in Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851831
- Sponsor's protocol ID
- 69HCL25_1040
- Other IDs
- 2026-A00194-47
- Acronym
- CGMUCODIAB
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Continuous Glucose Monitoring (CGM) in the Assessment of Glucose Metabolism Disorders in Children With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT07851831
- Acronym / sponsor ID
- CGMUCODIAB / 69HCL25_1040
- Keywords
- Cystic Fibrosis, Glucose metabolism disorders, Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 1 Oct 2026 (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.
Glucose metabolism disorders in cystic fibrosis (CF-GMD) are common and have a negative clinical impact. Screening currently relies on the oral glucose tolerance test (OGTT); however, this procedure is burdensome and complex for both patients and healthcare providers. Continuous glucose monitoring (CGM) is increasingly used in CF centers for CF-GMD screening, either alone or alongside the OGTT. While long-term (one-year) OGTT reproducibility is known to be poor, the short- and medium-term reproducibility of CGM remains unknown. This examination is poised to become a major tool in CF-GMD investigation, upon which critical therapeutic decisions could be based. The primary objective of this project is to evaluate the short-term variability of CGM data.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-diabetic patient with cystic fibrosis | Experimental | Device: Continuous Glucose Monitoring, Other: Eating Habits Questionnaire, Other: Use of an actigraphy watchChildren aged 10 to 17 years diagnosed with cystic fibrosis (CF). Patients presenting with one of the following three stages are included: normal glucose tolerance with or without indeterminate glucose tolerance (INDET), impaired fasting glucose (IFG), and impaired glucose tolerance (IGT). Patients will be equipped with a continuous glucose monitoring (CGM) sensor (Dexcom ONE+). |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Patients aged 10 to 17 years
- Diagnosed with cystic fibrosis (CF)
- Managed by the pediatric CF care center (CRCM) of the Groupement Hospitalier Est
- Patients presenting with one of the following three stages are included: normal glucose tolerance with or without indeterminate glucose tolerance (INDET), impaired fasting glucose (IFG), and impaired glucose tolerance (IGT)
Key exclusion criteria (9 listed)
- Patients with treated or untreated diabetes
- Patients presenting with a pulmonary exacerbation and currently receiving antibiotic therapy
- Patients participating in another clinical trial that could interfere, in the investigator's judgment, with the study findings
- Refusal of the patient and/or the legal guardian(s) to participate in the study
- Pregnant, parturient, or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Glucose MonitoringUpon enrollment, patients will be equipped with a continuous glucose monitoring (CGM) sensor (Dexcom ONE+). Sensors will be placed on the posterior aspect of the dominant arm at M0, M3, and M6, and additionally on the non-dominant arm at M0 only, in order to evaluate site-dependent variability. At each time point, the sensors will be worn for 7 days to record various CGM parameters, including glycemic variability (analyzed between M0-M3 and M0-M6). | Device | Non-diabetic patient with cystic fibrosis |
| Eating Habits QuestionnaireA 7-day dietary diary will be completed at M0, M3, and M6. | Other | Non-diabetic patient with cystic fibrosis |
| Use of an actigraphy watchParticipants will wear an actigraphy watch during 7 days at M0, M3 and M6 | Other | Non-diabetic patient with cystic fibrosis |
Primary outcome
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
Time frame: From enrollment to 3 months
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3.
29 secondary outcomes
The variability of other CGM parameters between M0 and M3: percentage of time in hypoglycemia (<70 mg/dL)
Time frame: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: percentage of time in hyperglycemia (>140 mg/dL)
Time frame: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: glycemic variability (%)
Time frame: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: mean glucose level (mg/dL)
Time frame: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: number of glucose excursions >200 mg/dL
Time frame: From enrollment to 3 months
The variability of other CGM parameters between M0 and M3: estimated HbA1c (eA1c)
Time frame: From enrollment to 3 months
The variability of CGM parameters between M0 and M6: "time in range" (%) (70-140 mg/dL)
Time frame: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: percentage of time in hypoglycemia (<70 mg/dL),
Time frame: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: percentage of time in hyperglycemia (>140 mg/dL),
Time frame: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: glycemic variability (%),
Time frame: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: mean glucose level (mg/dL),
Time frame: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: number of glucose excursions >200 mg/dL
Time frame: From enrollment to 6 months
The variability of CGM parameters between M0 and M6: estimated HbA1c (eA1c)
Time frame: From enrollment to 6 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): "time in range" (%) (70-140 mg/dL)
Time frame: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hypoglycemia (<70 mg/dL),
Time frame: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): percentage of time in hyperglycemia (>180 mg/dL)
Time frame: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): glycemic variability (%)
Time frame: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): mean glucose level (mg/dL)
Time frame: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): number of glucose excursions >200 mg/dL
Time frame: From enrollment to 3 months
The variability of CGM parameters according to the sensor placement site between M0 and M3 (inter-arm variability): estimated HbA1c (eA1c)
Time frame: From enrollment to 3 months
The variability of CGM parameters according to physical activity (percentage of daytime activity) : Variation in the number of steps
Time frame: From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition (body fat percentage)
Time frame: From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition
Time frame: From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition (fat mass percentage in the dominant arm)
Time frame: From enrollment to 3 months and 6 months
The variability of CGM parameters according to body composition (fat mass percentage in the non-dominant arm) : body fat in kg
Time frame: From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : Daily nutritional intake (kcal)
Time frame: From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : carbohydrates (kg)
Time frame: From enrollment to 3 months ans 6 months
The variability of CGM parameters according to nutritional intake : fats (kg)
Time frame: From enrollment to 3 months and 6 months
The variability of CGM parameters according to nutritional intake : proteins (kg)
Time frame: From enrollment to 3 months and 6 months
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 1 Oct 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring, Eating Habits Questionnaire and Use of an actigraphy watch in people with Glucose Metabolism Disorders in Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 9 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 1 Oct 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 France. 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 Kévin PERGE, Dr (04 72 11 88 90 ext. +33, kevin.perge@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The variability of the "time in range" (%) parameter (70-140 mg/dL) between M0 and M3. (time frame: From enrollment to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2026.