Cystic FibrosisNCT05568134
Alternate Measures of Glucose During OGTT Testing for CFRD
An observational study of Cystic Fibrosis and Cystic Fibrosis-related Diabetes, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Although early detection and treatment of cystic fibrosis-related diabetes (CFRD) can lead to significant clinical improvements and prolong life, rates of screening are poor likely due to the burdensome nature of oral glucose tolerance testing (OGTT). Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes
- What is being tested?
- Oral glucose tolerance test
- Type of treatment
- Pill or oral medicine
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2023to 13 Dec 2024
- 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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 15 subjects with cystic fibrosis (CF) over 10 years of age will be approached to participate.
Who may be able to join
- Diagnosis of cystic fibrosis
- ≥ 10 years of age
- Fluency in written and spoken English as the GTT@Home is currently only available in English
Who cannot join
- Hospitalization or treatment with IV antibiotics or supraphysiologic glucocorticoids within 4 weeks
- Major medical or psychiatric disorders other than CF
- Use of medications known to impact the accuracy of the Dexcom G7 (hydroxyurea, >2g acetaminophen per day)
- History of severe adhesive reactions that may lead to an inability to tolerate CGM wear
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Correlations Between CGM and Serum Glucose During OGTT Testing for CFRD
Although early detection and treatment of cystic fibrosis-related diabetes (CFRD) can lead to significant clinical improvements and prolong life, rates of screening are poor likely due to the burdensome nature of oral glucose tolerance testing (OGTT). The investigators propose to assess the feasibility and accuracy of two screening tools, continuous glucose monitoring (CGM) and a home OGTT kit (GTT@home). If this pilot study reveals acceptable accuracy of either device, this study will allow for future studies exploring home-based OGTT screening.
Read the detailed description
The investigators hypothesize that there will be strong agreement between plasma glucose and glucose as measured by either CGM or GTT@home at three different timepoints during an OGTT: fasting, 1-hour, and 2-hours.
- Conditions
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes
- Being tested
- Oral glucose tolerance test
- Keywords
- continuous glucose monitor, oral glucose tolerance test
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testDiagnostic test
An oral glucose tolerance test will be completed. A fasting glucose will be measured.
Participants will drink 1.75 g/kg of dextrose (up to a maximum of 75 grams) within 10 minutes. Glucose values will be measured at 1 hour and 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| OGTT Cohort | All enrolled participants will complete an OGTT. Receives: Diagnostic Test: Oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose
Differences in fasting glucose will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose.
Measured: Fasting glucose before OGTT
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose
Differences in the 1 hour glucose during the OGTT will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose.
Measured: 1 hour mark in OGTT
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose
Differences in the 2 hour glucose during the OGTT will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose.
Measured: 2 hour mark in OGTT
Secondary outcomes (7)
Agreement between the categorical diagnosis of normal glucose tolerance (NGT), impaired glucose tolerance (IGT), indeterminate glycemia (INDET), and CFRD as defined by plasma glucose, CGM glucose, and GTT@home glucose.
Categorical diagnosis of glucose tolerance as measured by plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose.
Measured: Up to 2 hours
Difference between plasma glucose and CGM measured glucose after the fasting glucose
Absolute differences between the glucose measurements will be measured in mg/dL
Measured: Up to 20 minutes after the fasting glucose
Difference between plasma glucose and CGM measured glucose after the 1 hour mark during the OGTT.
Absolute differences between the glucose measurements will be measured in mg/dL
Measured: Up to 20 minutes after the 1 hour mark in the OGTT
Difference between plasma glucose and CGM measured glucose after the 2 hour mark during the OGTT.
Absolute differences between the glucose measurements will be measured in mg/dL
Measured: Up to 20 minutes after the 2 hour mark in the OGTT
The ability of untrained participants to successfully complete the GTT@home kit without any guidance from the research team
Number of steps successfully completed as measured by the GTT@home instruction manual.
Measured: Up to 2 hours
Impact of wearing a real-time CGM on participants' awareness of the importance of screening for and diagnosing CFRD.
60 minute semi-structured interviews will be conducted with participants. Transcripts will be analyzed using semantic content analysis
Measured: Within 2 weeks after removal of the CGM
Perceived benefits and burdens of CGM use
Participants will complete a CGM Benefits and Burdens survey, a 16-item measure used to assess perceptions of CGM technology in people with type 1 diabetes. Surveys may be completed on paper or online, as per the participant's preference. The survey is scored on a 5-point scale (agree/disagree scale).
Measured: Within 2 weeks after removal of the CGM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start17 Jul 2023
- Primary completion13 Dec 2024
- Study completion13 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568134
- Sponsor's protocol ID
- 22-020249
- Status last verified
- Feb 2025
- First submitted
- 3 Oct 2022
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlations Between CGM and Serum Glucose During OGTT Testing for CFRD
- ClinicalTrials.gov ID
- NCT05568134
- Acronym / sponsor ID
- 22-020249
- Conditions
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes
- Keywords
- continuous glucose monitor, oral glucose tolerance test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 13 Dec 2024 (actual)
- Study completion
- 13 Dec 2024 (actual)
- First posted
- 5 Oct 2022 (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.
Although early detection and treatment of cystic fibrosis-related diabetes (CFRD) can lead to significant clinical improvements and prolong life, rates of screening are poor likely due to the burdensome nature of oral glucose tolerance testing (OGTT). The investigators propose to assess the feasibility and accuracy of two screening tools, continuous glucose monitoring (CGM) and a home OGTT kit (GTT@home). If this pilot study reveals acceptable accuracy of either device, this study will allow for future studies exploring home-based OGTT screening.
Detailed description
The investigators hypothesize that there will be strong agreement between plasma glucose and glucose as measured by either CGM or GTT@home at three different timepoints during an OGTT: fasting, 1-hour, and 2-hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OGTT Cohort | – | Diagnostic Test: Oral glucose tolerance testAll enrolled participants will complete an OGTT. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 15 subjects with cystic fibrosis (CF) over 10 years of age will be approached to participate.
Key inclusion criteria (3 listed)
- Diagnosis of cystic fibrosis
- ≥ 10 years of age
- Fluency in written and spoken English as the GTT@Home is currently only available in English
Key exclusion criteria (4 listed)
- Hospitalization or treatment with IV antibiotics or supraphysiologic glucocorticoids within 4 weeks
- Major medical or psychiatric disorders other than CF
- Use of medications known to impact the accuracy of the Dexcom G7 (hydroxyurea, >2g acetaminophen per day)
- History of severe adhesive reactions that may lead to an inability to tolerate CGM wear
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 |
|---|---|---|
| Oral glucose tolerance testAn oral glucose tolerance test will be completed. A fasting glucose will be measured. Participants will drink 1.75 g/kg of dextrose (up to a maximum of 75 grams) within 10 minutes. Glucose values will be measured at 1 hour and 2 hours. | Diagnostic test | OGTT Cohort |
Primary outcome
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose
Time frame: Fasting glucose before OGTT
Differences in fasting glucose will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose.
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose
Time frame: 1 hour mark in OGTT
Differences in the 1 hour glucose during the OGTT will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose.
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose
Time frame: 2 hour mark in OGTT
Differences in the 2 hour glucose during the OGTT will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose.
7 secondary outcomes
Agreement between the categorical diagnosis of normal glucose tolerance (NGT), impaired glucose tolerance (IGT), indeterminate glycemia (INDET), and CFRD as defined by plasma glucose, CGM glucose, and GTT@home glucose.
Time frame: Up to 2 hours
Difference between plasma glucose and CGM measured glucose after the fasting glucose
Time frame: Up to 20 minutes after the fasting glucose
Difference between plasma glucose and CGM measured glucose after the 1 hour mark during the OGTT.
Time frame: Up to 20 minutes after the 1 hour mark in the OGTT
Difference between plasma glucose and CGM measured glucose after the 2 hour mark during the OGTT.
Time frame: Up to 20 minutes after the 2 hour mark in the OGTT
The ability of untrained participants to successfully complete the GTT@home kit without any guidance from the research team
Time frame: Up to 2 hours
Impact of wearing a real-time CGM on participants' awareness of the importance of screening for and diagnosing CFRD.
Time frame: Within 2 weeks after removal of the CGM
Perceived benefits and burdens of CGM use
Time frame: Within 2 weeks after removal of the CGM
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 24 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Cystic Fibrosis-related Diabetes, run by Children's Hospital of Philadelphia 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 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: finished, as of the sponsor's last update on 24 Feb 2025. 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?
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose (time frame: Fasting glucose before OGTT). The study lists 3 primary outcomes in all. 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 24 Feb 2025.