Cystic FibrosisGEMNCT02211235
Glycemic Monitoring in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes recommend treatment for diabetes based on diagnostic criteria derived from adults with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 6 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 16 May 2018
- 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 6 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children and Adolescents ages 6-25, without diabetes. Out of 160 people, 45 will be healthy controls, 45 with Cystic Fibrosis (normal glucose tolerance), and 70 with Cystic Fibrosis-related diabetes or pre-diabetes.
Who may be able to join
- Healthy controls (n=45) -
- Age 10-25 years
- BMI <85th percentile
- Baseline health at enrollment
- CF controls (n=45) -
- Age 10-25 years
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- Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing)
- Baseline health at enrollment (no inclusion/exclusion criteria for CF patients based on lung function, BMI, pancreatic insufficiency, or genotype)
- CF prediabetes \& CFRD (n=70)
- Age 10-25 years
- Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing)
- History of abnormal oral glucose tolerance testing (2h-glucose >140, fasting plasma glucose >100,1hr glucose >200)
- If taking medication that affects glucose metabolism (ex. Insulin, insulin sensitizers, glucocorticoids, atypical antipsychotics), should be on a stable dose over the past 3 months
Who cannot join
- Healthy controls -
- Known diagnosis of diabetes or prediabetes (including type 1, type 2, MODY), abnormal oral glucose tolerance test (OGTT) (ie. fasting plasma glucose ≥100 or 2hr ≥140 mg/dl) or HbA1c ≥ 5.7%
- BMI ≥85th percentile
- Chronic disease that may affect glucose metabolism or use of medications affecting glucose metabolism in the past 3 months (ex. Insulin, insulin sensitizers, glucocorticoids, atypical antipsychotics)
- Presence of type 1 diabetes auto-antibodies in any individuals with a first degree relative with type 1 diabetes (will only include first degree relatives if they have had previous negative auto-antibody screening performed as part of participation in other studies such as the Trial Net studies at the Barbara Davis Center)
- Acute illness (ex. Asthma exacerbation, gastroenteritis, febrile illness)
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- Pregnancy
- CF participants -
- Diagnosis of type 1 diabetes, type 2 diabetes, or MODY
- Varying doses of medication affecting glucose metabolism in the past 3 months
- Pulmonary exacerbation associated with hospitalization, or systemic steroid requirement in the preceding 6 weeks
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado, University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Characterization of Glucose Variability by Continuous Glucose Monitoring in Non-diabetic Youth With and Without Cystic Fibrosis
Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes recommend treatment for diabetes based on diagnostic criteria derived from adults with type 2 diabetes. Increasing evidence supports treating early glucose abnormalities in cystic fibrosis patients to target CF specific outcomes, including lung function and nutrition (BMI-Body Mass Index). However, the criteria and timing of when to start insulin therapy in the 'prediabetic' state are unclear. A more accurate characterization of blood sugar variability in youth with and without CF will help the investigators better interpret continuous glucose monitor (CGM) findings in patients with CF prediabetes and diabetes and more accurately identify those individuals at greatest risk for disease progression.
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Healthy Controls, Diabetes, Cystic Fibrosis Related Diabetes (CFRD), CFRD
- Medical subject headings
- Cystic Fibrosis, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of time spent > 140 mg/dl on CGM
Percentage of time above normal glucose cut-point.
Measured: 7 days
Secondary outcomes (5)
The percentage of time spent > 120 mg/dl on CGM
Measures of glucose variability on CGM
Measured: 7 days
The percentage of time spent > 200 mg/dl on CGM
Measures of glucose variability on CGM
Measured: 7 days
The percentage of time spent < 70 mg/dl on CGM
Measures of glucose variability on CGM
Measured: 7 days
The percentage of time spent < 60 mg/dl on CGM
Measures of glucose variability on CGM
Measured: 7 days
The number of excursions > 200mg/dl in 24 hours for one week
Measures of glucose variability including peak glucose, mean glucose and measures of glucose variability on CGM.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startAug 2014
- Primary completion16 May 2018
- Study completion16 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine L Chan, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211235
- Sponsor's protocol ID
- 14-0960
- Other IDs
- UL1TR001082
- Acronym
- GEM
- Status last verified
- Mar 2023
- First submitted
- 29 Jul 2014
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chan CL, Pyle L, Vigers T, Zeitler PS, Nadeau KJ. The Relationship Between Continuous Glucose Monitoring and OGTT in Youth and Young Adults With Cystic Fibrosis. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e548-e560. doi: 10.1210/clinem/dgab692.
PubMed 34537845Tommerdahl KL, Brinton JT, Vigers T, Cree-Green M, Zeitler PS, Nadeau KJ, Chan CL. Delayed glucose peak and elevated 1-hour glucose on the oral glucose tolerance test identify youth with cystic fibrosis with lower oral disposition index. J Cyst Fibros. 2021 Mar;20(2):339-345. doi: 10.1016/j.jcf.2020.08.020. Epub 2020 Sep 11.
PubMed 32928701Chan CL, Hope E, Thurston J, Vigers T, Pyle L, Zeitler PS, Nadeau KJ. Hemoglobin A1c Accurately Predicts Continuous Glucose Monitoring-Derived Average Glucose in Youth and Young Adults With Cystic Fibrosis. Diabetes Care. 2018 Jul;41(7):1406-1413. doi: 10.2337/dc17-2419. Epub 2018 Apr 19.
PubMed 29674323
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Glucose Variability by Continuous Glucose Monitoring in Non-diabetic Youth With and Without Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02211235
- Acronym / sponsor ID
- GEM / 14-0960
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Healthy Controls, Diabetes, Cystic Fibrosis Related Diabetes (CFRD), CFRD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 16 May 2018 (actual)
- Study completion
- 16 May 2018 (actual)
- First posted
- 7 Aug 2014 (estimated)
- 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.
Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes recommend treatment for diabetes based on diagnostic criteria derived from adults with type 2 diabetes. Increasing evidence supports treating early glucose abnormalities in cystic fibrosis patients to target CF specific outcomes, including lung function and nutrition (BMI-Body Mass Index). However, the criteria and timing of when to start insulin therapy in the 'prediabetic' state are unclear. A more accurate characterization of blood sugar variability in youth with and without CF will help the investigators better interpret continuous glucose monitor (CGM) findings in patients with CF prediabetes and diabetes and more accurately identify those individuals at greatest risk for disease progression.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children and Adolescents ages 6-25, without diabetes. Out of 160 people, 45 will be healthy controls, 45 with Cystic Fibrosis (normal glucose tolerance), and 70 with Cystic Fibrosis-related diabetes or pre-diabetes.
Key inclusion criteria (13 listed)
- Healthy controls (n=45) -
- Age 10-25 years
- BMI <85th percentile
- Baseline health at enrollment
- CF controls (n=45) -
Key exclusion criteria (12 listed)
- Healthy controls -
- Known diagnosis of diabetes or prediabetes (including type 1, type 2, MODY), abnormal oral glucose tolerance test (OGTT) (ie. fasting plasma glucose ≥100 or 2hr ≥140 mg/dl) or HbA1c ≥ 5.7%
- BMI ≥85th percentile
- Chronic disease that may affect glucose metabolism or use of medications affecting glucose metabolism in the past 3 months (ex. Insulin, insulin sensitizers, glucocorticoids, atypical antipsychotics)
- Presence of type 1 diabetes auto-antibodies in any individuals with a first degree relative with type 1 diabetes (will only include first degree relatives if they have had previous negative auto-antibody screening performed as part of participation in other studies such as the Trial Net studies at the Barbara Davis Center)
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
The percentage of time spent > 140 mg/dl on CGM
Time frame: 7 days
Percentage of time above normal glucose cut-point.
5 secondary outcomes
The percentage of time spent > 120 mg/dl on CGM
Time frame: 7 days
The percentage of time spent > 200 mg/dl on CGM
Time frame: 7 days
The percentage of time spent < 70 mg/dl on CGM
Time frame: 7 days
The percentage of time spent < 60 mg/dl on CGM
Time frame: 7 days
The number of excursions > 200mg/dl in 24 hours for one week
Time frame: 7 days
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 22 Mar 2023.
- Derived from this study: PubMed 34537845Chan CL, Pyle L, Vigers T, Zeitler PS, Nadeau KJ. The Relationship Between Continuous Glucose Monitoring and OGTT in Youth and Young Adults With Cystic Fibrosis. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e548-e560. doi: 10.1210/clinem/dgab692.
- Derived from this study: PubMed 32928701Tommerdahl KL, Brinton JT, Vigers T, Cree-Green M, Zeitler PS, Nadeau KJ, Chan CL. Delayed glucose peak and elevated 1-hour glucose on the oral glucose tolerance test identify youth with cystic fibrosis with lower oral disposition index. J Cyst Fibros. 2021 Mar;20(2):339-345. doi: 10.1016/j.jcf.2020.08.020. Epub 2020 Sep 11.
- Derived from this study: PubMed 29674323Chan CL, Hope E, Thurston J, Vigers T, Pyle L, Zeitler PS, Nadeau KJ. Hemoglobin A1c Accurately Predicts Continuous Glucose Monitoring-Derived Average Glucose in Youth and Young Adults With Cystic Fibrosis. Diabetes Care. 2018 Jul;41(7):1406-1413. doi: 10.2337/dc17-2419. Epub 2018 Apr 19.
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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.
Christine L Chan, MD principal investigator
University of Colorado, Denver
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 Cystic Fibrosis, run by University of Colorado, Denver at 1 site in United States.
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 13 inclusion and 12 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 22 Mar 2023. 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 United States. 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?
The percentage of time spent > 140 mg/dl on CGM (time frame: 7 days). 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 NCT02211235, which also lists 3 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 22 Mar 2023.