An interventional study of Continuous Glucose Monitor in Cystic Fibrosis Related Diabetes and CGM, sponsored by Northwell Health. Recruiting at 1 site in United States. Open to participants aged 10 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Northwell Health · Not applicable, Interventional, and Screening
Among 717 studies in Cystic Fibrosis with a site in United States — 86 open to participants now, 111 under way, 8 of them phase 3. Cystic Fibrosis · United States.
Among the 717 studies in Cystic Fibrosis with a site in United States, this one is the 283rd largest by planned enrollment of the 517 interventional ones that give a count, is one of 20 that started in 2025, is one of 155 with no phase, reaches primary completion later than 64 of the 108 other live ones, and was the 713th registered.
1,621 studies on the registry are indexed under Cystic Fibrosis; 201 are open to participants now.
Browse Cystic Fibrosis studies →86 of the 717 studies in Cystic Fibrosis with a site in United States are open now. Recruiting first, the newest first:
Bettina Mittendorfer · Sites in United States
Ages 18–100 · Healthy volunteers
Aimmune Nestlé Health Science US R&D, LLC · Sites in United States, Bulgaria, Hungary and 4 more countries
Ages 18–85
Dartmouth-Hitchcock Medical Center · Sites in United States
Ages 3–18
Ghady Haidar · Sites in United States
Ages 18+
Anagram Therapeutics, Inc. · Sites in United States
Ages 12+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 156 Cystic Fibrosis studies recruiting now, 95 (61%) set no upper age limit and 45 (29%) stop at 75 or younger; 86 take children under 18; 41 take healthy volunteers.
This study: 10 Years to 25 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
717 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 109 · Phase 2 143 · Phase 3 108 · Phase 4 47
First in 1988; this study’s year is marked. 20 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 36 across 1,053 interventional studies indexed under Cystic Fibrosis.
Median enrollment 36 across the 517 interventional studies, 80 across the 193 observational. Of the 569 that completed or were terminated, 263 (46%) have results posted.
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250 of 717 have an industry lead sponsor. The 10 most frequent:
Northwell Health is the lead sponsor of 475 studies on the registry; 107 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 23 (51%) have results posted.
Northwell Health has 1 study filed under Cystic Fibrosis — fewer than ten, so there is no comparison to draw.
44 of the studies in Cystic Fibrosis with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06413368Phase 3Children's Hospital Los AngelesMaralixibat in Patients With Cystic Fibrosis and Constipation | 2027-06-30 |
| NCT06449677Phase 3Jaeb Center for Health ResearchBionic Pancreas in CFRD | 2027-06-30 |
| NCT06996951Phase 3Indiana UniversitySinonasal Therapies and Histologic Correlations of Patients With Cystic Fibrosis in the Era of Highly Effective Modulator Therapy | 2027-07 |
| NCT06237335ReCode TherapeuticsA Phase 2 Study Evaluating Safety and Tolerability of RCT2100 (CFTR mRNA) in Healthy Participants and in Participants With CF | 2026-11 |
| NCT03655223RTI InternationalEarly Check: Expanded Screening in Newborns | 2026-11-30 |
Add all 44 to your calendar (.ics) → With an account.
Among the 717 studies in Cystic Fibrosis with a site in United States, from their registry updates:
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As modulator therapies extend the lifespan of CF patients, the detection of complications like Cystic Fibrosis Related Diabetes (CFRD) becomes increasingly vital. The current gold standard for CFRD screening, the 2-hour OGTT, is cumbersome and suffers from low compliance. This study proposes that Continuous Glucose Monitoring (CGM) could offer a more comprehensive, easier, and potentially more compliant screening method. The research aims to correlate various CGM parameters (e.g., time in hyperglycemia) with traditional glycemic markers like OGTT glucose levels, GMI, average glucose, variability, and HbA1c. Additionally, the research seeks to understand patient and parent/guardian preferences for CFRD screening modalities. This prospective observational study will involve CF patients wearing a Dexcom CGM around the time of standard OGTT and HbA1c tests, followed by surveys, with the ultimate goal of paving the way for CGM to improve early detection and management of dysglycemia in CF children.
As modulator therapy changes the landscape of cystic fibrosis (CF), children with CF will live longer and healthier lives with less pulmonary exacerbations. Still, other complications like Cystic Fibrosis Related Diabetes and underlying dysglycemia may become more apparent as lifespans of CF patients increase. It is therefore essential that clinicians have the tools to understand early stages of dysglycemia to prevent long term complications of CFRD. At present, 2 hours 75-gram OGTT remains the gold standard annual screen for CFRD. This test is both cumbersome for patients and limits a clinician's interpretation of glycemic control to a limited time frame. Although OGTT is currently used to diagnose CFRD, it can be cumbersome for patients and time consuming. OGTT compliance is therefore not surprisingly low in the CF population with about 49 % of CF centers having a more than 50% completion of annual OGTT. Continuous glucose monitoring (CGM), on the other hand, offers the ability to obtain more data on longer time periods in a much easier fashion. Thus, CGMs have the potential to glean a more fine-tuned understanding of a patient's glycemic control. Moreover, CGMs can make glycemic testing easier on patients, thereby increasing compliance of annual glycemic testing. The investigators hypothesize the correlation of CGM parameters of hyperglycemia like % of time > 180 mg/dl, % of time> 150 mg/dL with 1- and 2-hour OGTT glucose levels, Glucose Management Indicator (GMI), average glucose, glucose variability, and HbA1c levels. The investigators also aim to explore patient views and preferences of OGTT and CGM for screening of CFRD through surveys after CGM wear.
The investigators hope to be able to correlate 1- and 2-hour glucose values on OGTT to % in range parameters on a continuous glucose monitor. This will pave the way to better understand glycemic control in children with CF and risk for CFRD with data from a CGM even without an OGTT in the future. The investigators also hope to understand patient and parent/guardian preferences towards CFRD screening modalities.
Study Design: Prospective observational study. Eligible patients will have a CGM placed for up to10-day wear within the 3 months before or after clinically appropriate OGTT and A1c. OGTT testing will include 1- and 2-hour glucose levels and HbA1c as per standard of care. A Dexcom CGM will be placed in clinic onto the subjects upper arm. Survey exploring patient and parent/guardian preference will be provided after the CGM is removed.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pediatric Cystic Fibrosis patients (ages 10-25 years) will wear a continuous glucose monitor (Dexcom G7) for up to 10 days within 3 months of an annual Oral Glucose Tolerance Test (OGTT) and complete a survey to evaluate correlations between CGM parameters and OGTT values and assess patient/guardian preferences for CFRD screening methods.
Device: Continuous Glucose Monitor
Continuous glucose monitors, such as Dexcom, have been established as a standard component of clinical care for continuous blood glucose monitoring. These devices are widely utilized in diabetes management clinics and demonstrate a robust safety and efficacy profile. The intervention also includes administration of a patient preference survey as outlined in the study protocol.
Average Blood Glucose Level from Continuous Glucose Monitoring
Mean glucose level recorded over the continuous glucose monitoring (CGM) wear period (mg/dL)
Time frame: Up to 10 days of CGM wear (within 3 months of the Oral Glucose Tolerance Test).
Percentage of Time Glucose Exceeds 150 mg/dL from Continuous Glucose Monitoring
The proportion of time during the CGM wear period that glucose levels were above 150 mg/dL (%)
Time frame: Up to 10 days of CGM wear (within 3 months of the Oral Glucose Tolerance Test).
Percentage of Time Glucose Exceeds 180 mg/dL from Continuous Glucose Monitoring
The proportion of time during the CGM wear period that glucose levels were above 180 mg/dL (%)
Time frame: Up to 10 days of CGM wear (within 3 months of the Oral Glucose Tolerance Test).
Fasting Plasma Glucose Level from Oral Glucose Tolerance Test
Plasma glucose level measured after an overnight fast, as part of the Oral Glucose Tolerance Test (OGTT) (mg/dL)
Time frame: Single measurement at the start of the OGTT (within 3 months of CGM wear).
1 hour Plasma Glucose Level from Oral Glucose Tolerance Test
Plasma glucose level measured 1 hour after glucose administration as part of the Oral Glucose Tolerance Test (OGTT) (mg/dL)
Time frame: Single measurement 1 hour after glucose load (within 3 months of CGM wear).
2-Hour Plasma Glucose Level from Oral Glucose Tolerance Test
Plasma glucose level measured 2 hours after glucose load administration during the OGTT (mg/dL)
Time frame: Single measurement 2 hours after glucose load (within 3 months of CGM wear).
Forced Expiratory Volume in 1 Second (FEV1) as a Percentage of Predicted
Lung function parameter reflecting the volume of air exhaled in the first second during a forced breath, expressed as a percentage of the predicted value. (%)
Time frame: Within 3 months of CGM placement (standard of care assessment).
Forced Vital Capacity (FVC) as a Percentage of Predicted
Lung function parameter reflecting the total volume of air exhaled during a forced breath, expressed as a percentage of the predicted value (%)
Time frame: Within 3 months of CGM placement (standard of care assessment).
Hemoglobin A1c (HbA1c) Level
A measure of average blood glucose level (%)
Time frame: At the time of OGTT (within 3 months of CGM wear).
Body Mass Index (BMI) Z-Score
Age- and sex-adjusted Body Mass Index standardized score, reflecting nutritional status (z-score)
Time frame: Within 3 months of CGM placement (standard of care assessment).
Response to Survey Question on CFRD Screening Preferences
Participant's (and/or parent/guardian's) response to the Likert scale questions regarding preferences for Cystic Fibrosis Related Diabetes
Time frame: After 10 days of CGM wear
Started Jun 2025 (actual). Primary completion is estimated for Aug 2027, 26 months after the start.
Of 214 non-industry interventional studies with no phase under Cystic Fibrosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 26 months is close to that.
Counting every sponsor, half of 229 studies reached it within 23 months; a quarter within 12 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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