Cystic FibrosisCFCGMNCT03961516
Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis
An observational study of Cystic Fibrosis and Cystic Fibrosis-related Diabetes, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate the utility of a continuous glucose monitor device (CGM) in screening for cystic fibrosis related diabetes. The investigators will also study how fat deposition in the pancreas and liver impacts insulin production and response, as measured by a frequently sampled oral… Read more about this study
- Who is it for?
- Ages 6 to 40 years
- Conditions the study is for
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes, Cystic Fibrosis Liver Disease
- What is being tested?
- Frequently Sampled Oral Glucose Tolerance Test and CGM and MRI Pancreas and Liver
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2019to 30 Aug 2021
- 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 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with cystic fibrosis will be recruited from the LeRoy W. Matthews CF Center at UH Cleveland Medical Center.
Who may be able to join
- Cystic fibrosis confirmed by sweat chloride or genetics
- Pancreatic insufficient or pancreatic sufficient
- No change in insulin status (either initiating or discontinuing) in the past 3 months
Who cannot join
- CF liver disease with portal hypertension
- Systemic glucocorticoid exposure the past 2 weeks (does not include inhaled)
- Current pulmonary exacerbation treated with antibiotics
- Baseline or current FEV1 <30% at time of recruitment
- Transplant recipient
- Pancreatic sufficient on insulin
- Started CFTR modulator in the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
The purpose of this study is to investigate the utility of a continuous glucose monitor device (CGM) in screening for cystic fibrosis related diabetes. The investigators will also study how fat deposition in the pancreas and liver impacts insulin production and response, as measured by a frequently sampled oral glucose tolerance test.
Read the detailed description
Cystic Fibrosis Related Diabetes (CFRD) occurs in 20% of adolescents and 30-40% of adults with cystic fibrosis. CFRD is associated with reduced lung function, lower body mass index, and increased mortality. The CF Foundation recommends yearly Oral Glucose Tolerance Test (OGTT) for all CF patients beginning at age 10 years. Unfortunately adherence to screening recommendations is poor, with fewer than 50% of the eligible CF patients completing OGTT each year. Additionally, the OGTT has been criticized for poor reproducibility and for not accurately reflecting real-life glycemic excursions.
The FreeStyle Libre Pro is a blinded CGM that can record up to 14 days of home-living glucose data on one sensor. This quarter-sized device is placed on the upper arm and requires no fingerstick calibrations. Multiple studies have demonstrated the utility of CGM in CF patients, but no study has determined the utility of CGM in replicating the results of an OGTT. The use of CGM in CFRD screening has the potential to reduce screening burden, increase screening adherence and provide useful information about home glycemic excursions.
Pancreatic steatosis is common in CF with complete pancreatic fat replacement occurring in some cases. Pancreatic steatosis is also seen in patients with type 2 diabetes and may impact insulin secretion or the rate of beta cell decline. MRI is the most sensitive tool for detecting pancreatic steatosis. Ferrozzi described four patterns of pancreatic fat replacement in CF patients: (1) diffusely hyperintense with variable lobular pattern, (2) homogenous hyperintensity without lobular pattern, (3) hyperintense parenchyma with focal hypointensity, and (4) no structural or signal intensity changes. No studies have directly compared the degree of pancreatic steatosis with OGTT derived measures of insulin secretion or glycemic excursions on CGM.
Hepatic steatosis is also common in CF patients and has an unclear impact on insulin sensitivity. Outside of CF, hepatic steatosis is associated with insulin resistance.
This study has two aims:
Aim 1: Determine how closely the FreeStyle Libre Pro CGM can replicate the results of an in-clinic oral glucose tolerance test.
Aim 2: Explore whether pancreatic and hepatic steatosis correlated with insulin secretion and sensitivity in CF patients.
- Conditions
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes, Cystic Fibrosis Liver Disease, Pancreatic Steatosis, Hepatic Steatosis
- Being tested
- Frequently Sampled Oral Glucose Tolerance Test and CGM, MRI Pancreas and Liver
- Keywords
- continuous glucose monitor, cystic fibrosis, cystic fibrosis related diabetes
- Medical subject headings
- Cystic Fibrosis, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Frequently Sampled Oral Glucose Tolerance Test and CGMDevice
Patients will undergo a 2 hour frequently sampled oral glucose tolerance test while wearing an active FreeStyle Libre Pro sensor. Using as a tool to collect data.
MRI Pancreas and LiverRadiation
Patients will undergo an MRI of the pancreas and liver
| Study group | Role | What they receive |
|---|---|---|
| Cystic Fibrosis, Pancreatic Sufficient | CF patients with exocrine pancreatic sufficiency Receives: Device: Frequently Sampled Oral Glucose Tolerance Test and CGM; Radiation: MRI Pancreas and Liver | |
| Cystic Fibrosis, Pancreatic Insufficient, No Insulin | CF patients with exocrine pancreatic insufficiency but not treated with insulin therapy Receives: Device: Frequently Sampled Oral Glucose Tolerance Test and CGM; Radiation: MRI Pancreas and Liver | |
| Cystic Fibrosis, Pancreatic Insufficient, Treated with Insulin | CF patients with exocrine pancreatic insufficiency who are treated with insulin therapy for CFRD Receives: Device: Frequently Sampled Oral Glucose Tolerance Test and CGM; Radiation: MRI Pancreas and Liver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic agreement between plasma glucose and CGM
Difference between blood glucose and CGM result will be calculated for each time point (0min, 30min, 60min, 90min, 120min).
Measured: 0 min-120min
Pancreatic Fat and Glycemic measures
Correlation between the degree of pancreatic fat replacement (Class 1-4 and fat fraction) and measures of beta cell function on glucose tolerance testing
Measured: 0min-120min
Secondary outcomes (2)
CGM results in CFRD vs. CFND
Comparison of CGM parameters (time and excursions >140mg/dL and >200mg/dL between patients with insulin treated CFRD and no insulin treated CFRD
Measured: 0 min-120min
Pancreatic Fat by Modulator Status
Comparison of pancreatic fat (Ferrozzi category and fat fraction) in patients who are and are not receiving a CFTR modulator.
Measured: 0min-120min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start1 May 2019
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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 Hospitals Cleveland Medical CenterThe 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
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Kutney, University Hospitals Cleveland Medical Center
- Investigators
- Katherine Kutney, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03961516
- Sponsor's protocol ID
- 20181150
- Acronym
- CFCGM
- Status last verified
- May 2022
- First submitted
- 16 May 2019
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Moran A, Dunitz J, Nathan B, Saeed A, Holme B, Thomas W. Cystic fibrosis-related diabetes: current trends in prevalence, incidence, and mortality. Diabetes Care. 2009 Sep;32(9):1626-31. doi: 10.2337/dc09-0586. Epub 2009 Jun 19.
PubMed 19542209Adler AI, Shine BS, Chamnan P, Haworth CS, Bilton D. Genetic determinants and epidemiology of cystic fibrosis-related diabetes: results from a British cohort of children and adults. Diabetes Care. 2008 Sep;31(9):1789-94. doi: 10.2337/dc08-0466. Epub 2008 Jun 5.
PubMed 18535191Annual Data Report 2016 Cystic Fibrosis Foundation Patient Registry [Internet]. Cystic Fibrosis Foundation Patient Registry. 2016
Mainguy C, Bellon G, Delaup V, Ginoux T, Kassai-Koupai B, Mazur S, Rabilloud M, Remontet L, Reix P. Sensitivity and specificity of different methods for cystic fibrosis-related diabetes screening: is the oral glucose tolerance test still the standard? J Pediatr Endocrinol Metab. 2017 Jan 1;30(1):27-35. doi: 10.1515/jpem-2016-0184.
PubMed 27977404Walshaw M. Routine OGTT screening for CFRD - no thanks. J R Soc Med. 2009 Jul;102 Suppl 1(Suppl 1):40-4. doi: 10.1258/jrsm.2009.s19009. No abstract available.
PubMed 19605874Li A, Vigers T, Pyle L, Zemanick E, Nadeau K, Sagel SD, Chan CL. Continuous glucose monitoring in youth with cystic fibrosis treated with lumacaftor-ivacaftor. J Cyst Fibros. 2019 Jan;18(1):144-149. doi: 10.1016/j.jcf.2018.07.010. Epub 2018 Aug 10.
PubMed 30104123Leclercq A, Gauthier B, Rosner V, Weiss L, Moreau F, Constantinescu AA, Kessler R, Kessler L. Early assessment of glucose abnormalities during continuous glucose monitoring associated with lung function impairment in cystic fibrosis patients. J Cyst Fibros. 2014 Jul;13(4):478-84. doi: 10.1016/j.jcf.2013.11.005. Epub 2013 Dec 17.
PubMed 24359972Franzese A, Valerio G, Buono P, Spagnuolo MI, Sepe A, Mozzillo E, De Simone I, Raia V. Continuous glucose monitoring system in the screening of early glucose derangements in children and adolescents with cystic fibrosis. J Pediatr Endocrinol Metab. 2008 Feb;21(2):109-16. doi: 10.1515/jpem.2008.21.2.109.
PubMed 18422023O'Riordan SM, Hindmarsh P, Hill NR, Matthews DR, George S, Greally P, Canny G, Slattery D, Murphy N, Roche E, Costigan C, Hoey H. Validation of continuous glucose monitoring in children and adolescents with cystic fibrosis: a prospective cohort study. Diabetes Care. 2009 Jun;32(6):1020-2. doi: 10.2337/dc08-1925. Epub 2009 Mar 11.
PubMed 19279304Jefferies C, Solomon M, Perlman K, Sweezey N, Daneman D. Continuous glucose monitoring in adolescents with cystic fibrosis. J Pediatr. 2005 Sep;147(3):396-8. doi: 10.1016/j.jpeds.2005.05.004.
PubMed 16182684Della Corte C, Mosca A, Majo F, Lucidi V, Panera N, Giglioni E, Monti L, Stronati L, Alisi A, Nobili V. Nonalcoholic fatty pancreas disease and Nonalcoholic fatty liver disease: more than ectopic fat. Clin Endocrinol (Oxf). 2015 Nov;83(5):656-62. doi: 10.1111/cen.12862. Epub 2015 Aug 12.
PubMed 26201937Engjom T, Kavaliauskiene G, Tjora E, Erchinger F, Wathle G, Laerum BN, Njolstad PR, Frokjaer JB, Gilja OH, Dimcevski G, Haldorsen IS. Sonographic pancreas echogenicity in cystic fibrosis compared to exocrine pancreatic function and pancreas fat content at Dixon-MRI. PLoS One. 2018 Jul 26;13(7):e0201019. doi: 10.1371/journal.pone.0201019. eCollection 2018.
PubMed 30048483Ferrozzi F, Bova D, Campodonico F, De Chiara F, Uccelli M, Bacchini E, Grinzcich R, de Angelis GL, Battistini A. Cystic fibrosis: MR assessment of pancreatic damage. Radiology. 1996 Mar;198(3):875-9. doi: 10.1148/radiology.198.3.8628886.
PubMed 8628886Lindblad A, Glaumann H, Strandvik B. Natural history of liver disease in cystic fibrosis. Hepatology. 1999 Nov;30(5):1151-8. doi: 10.1002/hep.510300527.
PubMed 10534335Ayoub F, Trillo-Alvarez C, Morelli G, Lascano J. Risk factors for hepatic steatosis in adults with cystic fibrosis: Similarities to non-alcoholic fatty liver disease. World J Hepatol. 2018 Jan 27;10(1):34-40. doi: 10.4254/wjh.v10.i1.34.
PubMed 29399276
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03961516
- Acronym / sponsor ID
- CFCGM / 20181150
- Conditions
- Cystic Fibrosis, Cystic Fibrosis-related Diabetes, Cystic Fibrosis Liver Disease, Pancreatic Steatosis, Hepatic Steatosis
- Keywords
- continuous glucose monitor, cystic fibrosis, cystic fibrosis related diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 23 May 2019 (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.
The purpose of this study is to investigate the utility of a continuous glucose monitor device (CGM) in screening for cystic fibrosis related diabetes. The investigators will also study how fat deposition in the pancreas and liver impacts insulin production and response, as measured by a frequently sampled oral glucose tolerance test.
Detailed description
Cystic Fibrosis Related Diabetes (CFRD) occurs in 20% of adolescents and 30-40% of adults with cystic fibrosis. CFRD is associated with reduced lung function, lower body mass index, and increased mortality. The CF Foundation recommends yearly Oral Glucose Tolerance Test (OGTT) for all CF patients beginning at age 10 years. Unfortunately adherence to screening recommendations is poor, with fewer than 50% of the eligible CF patients completing OGTT each year. Additionally, the OGTT has been criticized for poor reproducibility and for not accurately reflecting real-life glycemic excursions.
The FreeStyle Libre Pro is a blinded CGM that can record up to 14 days of home-living glucose data on one sensor. This quarter-sized device is placed on the upper arm and requires no fingerstick calibrations. Multiple studies have demonstrated the utility of CGM in CF patients, but no study has determined the utility of CGM in replicating the results of an OGTT. The use of CGM in CFRD screening has the potential to reduce screening burden, increase screening adherence and provide useful information about home glycemic excursions.
Pancreatic steatosis is common in CF with complete pancreatic fat replacement occurring in some cases. Pancreatic steatosis is also seen in patients with type 2 diabetes and may impact insulin secretion or the rate of beta cell decline. MRI is the most sensitive tool for detecting pancreatic steatosis. Ferrozzi described four patterns of pancreatic fat replacement in CF patients: (1) diffusely hyperintense with variable lobular pattern, (2) homogenous hyperintensity without lobular pattern, (3) hyperintense parenchyma with focal hypointensity, and (4) no structural or signal intensity changes. No studies have directly compared the degree of pancreatic steatosis with OGTT derived measures of insulin secretion or glycemic excursions on CGM.
Hepatic steatosis is also common in CF patients and has an unclear impact on insulin sensitivity. Outside of CF, hepatic steatosis is associated with insulin resistance.
This study has two aims:
Aim 1: Determine how closely the FreeStyle Libre Pro CGM can replicate the results of an in-clinic oral glucose tolerance test.
Aim 2: Explore whether pancreatic and hepatic steatosis correlated with insulin secretion and sensitivity in CF patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cystic Fibrosis, Pancreatic Sufficient | – | Device: Frequently Sampled Oral Glucose Tolerance Test and CGM, Radiation: MRI Pancreas and LiverCF patients with exocrine pancreatic sufficiency |
| Cystic Fibrosis, Pancreatic Insufficient, No Insulin | – | Device: Frequently Sampled Oral Glucose Tolerance Test and CGM, Radiation: MRI Pancreas and LiverCF patients with exocrine pancreatic insufficiency but not treated with insulin therapy |
| Cystic Fibrosis, Pancreatic Insufficient, Treated with Insulin | – | Device: Frequently Sampled Oral Glucose Tolerance Test and CGM, Radiation: MRI Pancreas and LiverCF patients with exocrine pancreatic insufficiency who are treated with insulin therapy for CFRD |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with cystic fibrosis will be recruited from the LeRoy W. Matthews CF Center at UH Cleveland Medical Center.
Key inclusion criteria (3 listed)
- Cystic fibrosis confirmed by sweat chloride or genetics
- Pancreatic insufficient or pancreatic sufficient
- No change in insulin status (either initiating or discontinuing) in the past 3 months
Key exclusion criteria (7 listed)
- CF liver disease with portal hypertension
- Systemic glucocorticoid exposure the past 2 weeks (does not include inhaled)
- Current pulmonary exacerbation treated with antibiotics
- Baseline or current FEV1 <30% at time of recruitment
- Transplant recipient
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 |
|---|---|---|
| Frequently Sampled Oral Glucose Tolerance Test and CGMPatients will undergo a 2 hour frequently sampled oral glucose tolerance test while wearing an active FreeStyle Libre Pro sensor. Using as a tool to collect data. | Device | Cystic Fibrosis, Pancreatic Insufficient, No Insulin, Cystic Fibrosis, Pancreatic Insufficient, Treated with Insulin, Cystic Fibrosis, Pancreatic Sufficient |
| MRI Pancreas and LiverPatients will undergo an MRI of the pancreas and liver | Radiation | Cystic Fibrosis, Pancreatic Insufficient, No Insulin, Cystic Fibrosis, Pancreatic Insufficient, Treated with Insulin, Cystic Fibrosis, Pancreatic Sufficient |
Primary outcome
Glycemic agreement between plasma glucose and CGM
Time frame: 0 min-120min
Difference between blood glucose and CGM result will be calculated for each time point (0min, 30min, 60min, 90min, 120min).
Pancreatic Fat and Glycemic measures
Time frame: 0min-120min
Correlation between the degree of pancreatic fat replacement (Class 1-4 and fat fraction) and measures of beta cell function on glucose tolerance testing
2 secondary outcomes
CGM results in CFRD vs. CFND
Time frame: 0 min-120min
Pancreatic Fat by Modulator Status
Time frame: 0min-120min
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 20 May 2022.
- Background: PubMed 19542209Moran A, Dunitz J, Nathan B, Saeed A, Holme B, Thomas W. Cystic fibrosis-related diabetes: current trends in prevalence, incidence, and mortality. Diabetes Care. 2009 Sep;32(9):1626-31. doi: 10.2337/dc09-0586. Epub 2009 Jun 19.
- Background: PubMed 18535191Adler AI, Shine BS, Chamnan P, Haworth CS, Bilton D. Genetic determinants and epidemiology of cystic fibrosis-related diabetes: results from a British cohort of children and adults. Diabetes Care. 2008 Sep;31(9):1789-94. doi: 10.2337/dc08-0466. Epub 2008 Jun 5.
- BackgroundAnnual Data Report 2016 Cystic Fibrosis Foundation Patient Registry [Internet]. Cystic Fibrosis Foundation Patient Registry. 2016
- Background: PubMed 27977404Mainguy C, Bellon G, Delaup V, Ginoux T, Kassai-Koupai B, Mazur S, Rabilloud M, Remontet L, Reix P. Sensitivity and specificity of different methods for cystic fibrosis-related diabetes screening: is the oral glucose tolerance test still the standard? J Pediatr Endocrinol Metab. 2017 Jan 1;30(1):27-35. doi: 10.1515/jpem-2016-0184.
- Background: PubMed 19605874Walshaw M. Routine OGTT screening for CFRD - no thanks. J R Soc Med. 2009 Jul;102 Suppl 1(Suppl 1):40-4. doi: 10.1258/jrsm.2009.s19009. No abstract available.
- Background: PubMed 30104123Li A, Vigers T, Pyle L, Zemanick E, Nadeau K, Sagel SD, Chan CL. Continuous glucose monitoring in youth with cystic fibrosis treated with lumacaftor-ivacaftor. J Cyst Fibros. 2019 Jan;18(1):144-149. doi: 10.1016/j.jcf.2018.07.010. Epub 2018 Aug 10.
- Background: PubMed 24359972Leclercq A, Gauthier B, Rosner V, Weiss L, Moreau F, Constantinescu AA, Kessler R, Kessler L. Early assessment of glucose abnormalities during continuous glucose monitoring associated with lung function impairment in cystic fibrosis patients. J Cyst Fibros. 2014 Jul;13(4):478-84. doi: 10.1016/j.jcf.2013.11.005. Epub 2013 Dec 17.
- Background: PubMed 18422023Franzese A, Valerio G, Buono P, Spagnuolo MI, Sepe A, Mozzillo E, De Simone I, Raia V. Continuous glucose monitoring system in the screening of early glucose derangements in children and adolescents with cystic fibrosis. J Pediatr Endocrinol Metab. 2008 Feb;21(2):109-16. doi: 10.1515/jpem.2008.21.2.109.
- Background: PubMed 19279304O'Riordan SM, Hindmarsh P, Hill NR, Matthews DR, George S, Greally P, Canny G, Slattery D, Murphy N, Roche E, Costigan C, Hoey H. Validation of continuous glucose monitoring in children and adolescents with cystic fibrosis: a prospective cohort study. Diabetes Care. 2009 Jun;32(6):1020-2. doi: 10.2337/dc08-1925. Epub 2009 Mar 11.
- Background: PubMed 16182684Jefferies C, Solomon M, Perlman K, Sweezey N, Daneman D. Continuous glucose monitoring in adolescents with cystic fibrosis. J Pediatr. 2005 Sep;147(3):396-8. doi: 10.1016/j.jpeds.2005.05.004.
- Background: PubMed 26201937Della Corte C, Mosca A, Majo F, Lucidi V, Panera N, Giglioni E, Monti L, Stronati L, Alisi A, Nobili V. Nonalcoholic fatty pancreas disease and Nonalcoholic fatty liver disease: more than ectopic fat. Clin Endocrinol (Oxf). 2015 Nov;83(5):656-62. doi: 10.1111/cen.12862. Epub 2015 Aug 12.
- Background: PubMed 30048483Engjom T, Kavaliauskiene G, Tjora E, Erchinger F, Wathle G, Laerum BN, Njolstad PR, Frokjaer JB, Gilja OH, Dimcevski G, Haldorsen IS. Sonographic pancreas echogenicity in cystic fibrosis compared to exocrine pancreatic function and pancreas fat content at Dixon-MRI. PLoS One. 2018 Jul 26;13(7):e0201019. doi: 10.1371/journal.pone.0201019. eCollection 2018.
- Individual participant dataSharing planned: No
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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.
Katherine Kutney, MD principal investigator
University Hospitals Cleveland Medical Center
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 University Hospitals Cleveland Medical Center 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 7 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 20 May 2022. 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?
Glycemic agreement between plasma glucose and CGM (time frame: 0 min-120min). The study lists 2 primary outcomes in all. 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 NCT03961516, which also lists 15 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 20 May 2022.