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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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
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

Other trials in France

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 groups in NCT07851831
Study groupRoleWhat they receive
Non-diabetic patient with cystic fibrosisExperimentalChildren 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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.

  1. First posted1 Oct 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionFeb 2028 (estimated)
  4. Study completionMay 2028 (estimated)

Resources

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)
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

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.

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