Cystic Fibrosis-related DiabetesNCT06560463
Continuous Glucose Monitoring and OGTT Screen for Cystic Fibrosis Related Diabetes in Cystic Fibrosis
An observational study of Cystic Fibrosis-related Diabetes and Cystic Fibrosis, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Cystic Fibrosis (CF) related diabetes (CFRD) is a unique form of diabetes mellitus, different from type 1 diabetes and type 2 diabetes. The diagnosis of CFRD is associated with a decline in pulmonary function, decreased nutritional status, and increased mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis
- What is being tested?
- Access to Dexcom G7 CGM Data
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2025to 30 Sep 2027
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with Cystic Fibrosis, age 18 years and older, who receive care in the Froedtert and MCW Adult Cystic Fibrosis program.
Who may be able to join
- An adult patient, diagnosed with CF, established with Froedtert Multidisciplinary CF Clinic.
- Normal glucose tolerance or impaired glucose tolerance per OGTT completed in 2024.
- At healthy baseline status at time of CGM wear and OGTT.
Who cannot join
- Diagnosed with CFRD and treating with diabetogenic medications.
- s/p transplant
- pregnancy
- failure to wear CGM for entirety of 10 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Julie Biller, MD, 414-456-7043, jbiller@mcw.edu
Julie Biller, MD
About this study
Official title: Comparison of Continous Glucose Monitor and OGTT as a Screen for Cystic Fibrosis Related Diabetes and Impaired Glucose Tolerance
Cystic Fibrosis (CF) related diabetes (CFRD) is a unique form of diabetes mellitus, different from type 1 diabetes and type 2 diabetes. The diagnosis of CFRD is associated with a decline in pulmonary function, decreased nutritional status, and increased mortality. CFRD is extremely common in people with CF, occurring in approximately 40-50% of adults with CF. Impaired glucose tolerance or dysglycemia is also very common in CF. It is standard of care to screen for CFRD annually from the age of 10 years with a two-hour Oral Glucose Tolerance Test (OGTT) with 75 g dextrose. The gold standard screening for CFRD is the OGTT which is problematic as it is time consuming for patient and staff and adherence to annual screening is low among CF centers.
Survival has improved dramatically with the advent of CFTR modulators and it is presumed that the incidence of CFRD will increase with increased life expectancy. The Cystic Fibrosis Foundation (CFF) has developed the oldest disease specific patient registry, consisting of approximately 35000 patients, so there is vast historical information available on individual patients and larger datasets on the CF community as a whole. Based on the 2021 CFF patient registry data, the current life expectancy for CF patients born between 2017 and 2021 is 53 years - a 15 year increase from a decade ago.
Read the detailed description
Research design and methods
- Clinic will continue to follow CFF standard of care guidelines. Subjects will complete the annual OGTT and an annual HgbA1c.
- Sample Dexcom G7 Sensors will be provided to the subjects for 10 day wear during a routine CF clinic appointment.
- The clinic RD will provide education on sensor application and assist the subjects in applying the sensors during the CF clinic visit.
- The clinic RD will assist subjects with install of phone applications (Dexcom G7 and Dexcom Clarity) to track data and produce reports. The interpretation of reports will be reviewed with the subjects.
- The clinic RD will review dietary sources of carbohydrates and request patients add notes with estimation of carbohydrate (g) intake in Dexcom G7 app for the 10 days
- The clinic RD will set up accounts for the subjects to share data in the Dexcom Clarity online platform.
- After 10 days of CGM wear the clinicians will review reports for time in range (TIR), incidence of hypoglycemia, % readings of hyperglycemia, glycemic variability.
- Clinic RD will also record subject body weight trajectory and if a CFTR modulator is prescribed.
- Data will be entered in RedCap for direct comparison of CGM data, HGbA1c and OGTT results.
Relevant CF standard of care data that will be entered into redcap:
- CF genetic mutations
- Pancreatic sufficiency status
- BMI trends
- Number of CF exacerbations and severity
- FEV1 trends
- Glycohemoglobin levels
- Lipid levels
- 2 hour hypoglycemia on CF standard OGTT
- Blood pressure trends
- Patient age Statistical Justification for number of subjects: The research team will be able to recruit a maximum of 30 patients for the study who will use Continual Glucose Monitoring (CGM) for the duration of the study period. Given about 40% of CF patients are expected to develop CFRD, there will be adequate variability in the data and adequate sample size to assess diagnostic test performance in this group.
Data Analysis: Descriptive statistics of patient sample characteristics will be performed with mean, standard deviation for continuous variables and counts, percentages for categorical variables. Several diagnosis and screening test performance measures such as sensitivity, specificity, receiver operating characteristic curves, area under the curve, positive predictive value, negative predictive value will be applied in the study. The oral glucose tolerance test (OGTT) will be used as the gold standard and compared against continuous glucose monitoring (CGM) (I.E. glucose level, time in range (TIR), etc ), and used to determine whether CGM effectively screens for Cystic Fibrosis Related Diabetes
- Conditions
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis
- Being tested
- Access to Dexcom G7 CGM Data
- Keywords
- cystic fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to Dexcom G7 CGM DataDevice
Eligible patients will undergo Continuous Glucose Monitoring using the Dexcom G7
| Study group | Role | What they receive |
|---|---|---|
| Cystic Fibrosis | Not described Receives: Device: Access to Dexcom G7 CGM Data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose measurement
Blood glucose levels will be continuously monitored over a ten-day period using a Dexcom G7 continuous glucose monitor (CGM)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start13 Jan 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis-related DiabetesStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Biller, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560463
- Sponsor's protocol ID
- PRO00051083
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Continous Glucose Monitor and OGTT as a Screen for Cystic Fibrosis Related Diabetes and Impaired Glucose Tolerance
- ClinicalTrials.gov ID
- NCT06560463
- Acronym / sponsor ID
- PRO00051083
- Conditions
- Cystic Fibrosis-related Diabetes, Cystic Fibrosis
- Keywords
- cystic fibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 19 Aug 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.
Cystic Fibrosis (CF) related diabetes (CFRD) is a unique form of diabetes mellitus, different from type 1 diabetes and type 2 diabetes. The diagnosis of CFRD is associated with a decline in pulmonary function, decreased nutritional status, and increased mortality. CFRD is extremely common in people with CF, occurring in approximately 40-50% of adults with CF. Impaired glucose tolerance or dysglycemia is also very common in CF. It is standard of care to screen for CFRD annually from the age of 10 years with a two-hour Oral Glucose Tolerance Test (OGTT) with 75 g dextrose. The gold standard screening for CFRD is the OGTT which is problematic as it is time consuming for patient and staff and adherence to annual screening is low among CF centers.
Survival has improved dramatically with the advent of CFTR modulators and it is presumed that the incidence of CFRD will increase with increased life expectancy. The Cystic Fibrosis Foundation (CFF) has developed the oldest disease specific patient registry, consisting of approximately 35000 patients, so there is vast historical information available on individual patients and larger datasets on the CF community as a whole. Based on the 2021 CFF patient registry data, the current life expectancy for CF patients born between 2017 and 2021 is 53 years - a 15 year increase from a decade ago.
Detailed description
Research design and methods
- Clinic will continue to follow CFF standard of care guidelines. Subjects will complete the annual OGTT and an annual HgbA1c.
- Sample Dexcom G7 Sensors will be provided to the subjects for 10 day wear during a routine CF clinic appointment.
- The clinic RD will provide education on sensor application and assist the subjects in applying the sensors during the CF clinic visit.
- The clinic RD will assist subjects with install of phone applications (Dexcom G7 and Dexcom Clarity) to track data and produce reports. The interpretation of reports will be reviewed with the subjects.
- The clinic RD will review dietary sources of carbohydrates and request patients add notes with estimation of carbohydrate (g) intake in Dexcom G7 app for the 10 days
- The clinic RD will set up accounts for the subjects to share data in the Dexcom Clarity online platform.
- After 10 days of CGM wear the clinicians will review reports for time in range (TIR), incidence of hypoglycemia, % readings of hyperglycemia, glycemic variability.
- Clinic RD will also record subject body weight trajectory and if a CFTR modulator is prescribed.
- Data will be entered in RedCap for direct comparison of CGM data, HGbA1c and OGTT results.
Relevant CF standard of care data that will be entered into redcap:
- CF genetic mutations
- Pancreatic sufficiency status
- BMI trends
- Number of CF exacerbations and severity
- FEV1 trends
- Glycohemoglobin levels
- Lipid levels
- 2 hour hypoglycemia on CF standard OGTT
- Blood pressure trends
- Patient age Statistical Justification for number of subjects: The research team will be able to recruit a maximum of 30 patients for the study who will use Continual Glucose Monitoring (CGM) for the duration of the study period. Given about 40% of CF patients are expected to develop CFRD, there will be adequate variability in the data and adequate sample size to assess diagnostic test performance in this group.
Data Analysis: Descriptive statistics of patient sample characteristics will be performed with mean, standard deviation for continuous variables and counts, percentages for categorical variables. Several diagnosis and screening test performance measures such as sensitivity, specificity, receiver operating characteristic curves, area under the curve, positive predictive value, negative predictive value will be applied in the study. The oral glucose tolerance test (OGTT) will be used as the gold standard and compared against continuous glucose monitoring (CGM) (I.E. glucose level, time in range (TIR), etc ), and used to determine whether CGM effectively screens for Cystic Fibrosis Related Diabetes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis | – | Device: Access to Dexcom G7 CGM Data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with Cystic Fibrosis, age 18 years and older, who receive care in the Froedtert and MCW Adult Cystic Fibrosis program.
Key inclusion criteria (3 listed)
- An adult patient, diagnosed with CF, established with Froedtert Multidisciplinary CF Clinic.
- Normal glucose tolerance or impaired glucose tolerance per OGTT completed in 2024.
- At healthy baseline status at time of CGM wear and OGTT.
Key exclusion criteria (4 listed)
- Diagnosed with CFRD and treating with diabetogenic medications.
- s/p transplant
- pregnancy
- failure to wear CGM for entirety of 10 days
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 |
|---|---|---|
| Access to Dexcom G7 CGM DataEligible patients will undergo Continuous Glucose Monitoring using the Dexcom G7 | Device | Cystic Fibrosis |
Primary outcome
Blood glucose measurement
Time frame: 10 days
Blood glucose levels will be continuously monitored over a ten-day period using a Dexcom G7 continuous glucose monitor (CGM)
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 31 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Cystic Fibrosis-related Diabetes and Cystic Fibrosis, run by Medical College of Wisconsin 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: looking for participants now, as of the sponsor's last update on 31 Jul 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 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?
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 julie A. Biller, MD (414-955-7040, jbiller@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood glucose measurement (time frame: 10 days). 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 31 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.