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| ID | Type | Description | Link |
|---|---|---|---|
| 007365A124 | Other Grant/Funding Number | Cystic Fibrosis Foundation |
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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
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This multicenter cross-sectional study will include a diverse population of adolescents and adults with CF.
The overall Aim is to describe prevalence of diabetes microvascular complications and macrovascular surrogates in people with established CFRD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individuals with Cystic Fibrosis-Related Diabetes | Individuals diagnosed with Cystic Fibrosis-Related Diabetes for more than 5 years before enrollment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| observational study | Other | This is an observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microvascular Complications | To describe the rates of microvascular complications (retinopathy, nephropathy, and peripheral neuropathy) and their relationships with HbA1c and diabetes duration in diverse cohort of adolescents and adults with CFRD for ≥5 years. | From enrollment to the end of the participant's participation or 4 weeks |
| Macrovascular Surrogates | To describe macrovascular surrogates (resting blood pressure (BP), fasting lipids) and their relationship with HbA1c, diabetes duration and BMI in a diverse cohort with established CFRD. | From enrollment to the end of the participant's participation or 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PhenX English Proficiency | This questionnaire will be used to describe the social determinants of health in the study population and their cross-sectional relationships with microvascular complications and macrovascular surrogates will largely be explored. | From enrollment to the end of the participant's participation or 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Outcome - Participant diversity | This will measure diversity of individuals who were approached for study inclusion, who were recruited, who consented and who partially or fully completed study procedures as well as barriers and facilitators to recruitment. | From enrollment to the end of the participant's participation or 4 weeks |
Inclusion Criteria:
Exclusion Criteria:
Pulse Wave Velocity Exclusion Criteria:
Erratic, accelerated or mechanically controlled irregular heart rhythms including arrhythmias
Carotid or aortic valve stenosis
Peripheral artery disease or leg artery disease
Generalized constriction or localized spasm of muscular conduit arteries such as seen immediately after hypothermic cardiopulmonary bypass surgery or accompanying Raynaud's phenomena or intense cold.
Possible exclusions based on investigator medical provider assessment (additional precautions may be followed to allow inclusion):
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Individuals with CFRD diagnosis ≥ 5 years at time of enrollment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Judy Sibayan, MPH, CCRP | Contact | 813-975-8690 | jsibayan@jaeb.org | |
| Haley Fonseca, PhD, RDN, LDN | Contact | 813-975-8690 | hfonseca@jaeb.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Not yet recruiting | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Agbaje AO, Barker AR, Tuomainen TP. Differing Relations Of Arterial Stiffness And Carotid Intima-Media Thickness In Adolescence With Metabolic Risks In Young Adulthood: The ALSPAC Study. Circulation. 2021;144(Suppl_1):A13236-A. doi: doi:10.1161/circ.144.suppl_1.13236 | ||
| 31201031 | Background | Kelly A, Magge SN, Walega R, Cochrane C, Pipan ME, Zemel BS, Cohen MS, Gidding SS, Townsend R. Cross-Sectional Study of Arterial Stiffness in Adolescents with Down Syndrome. J Pediatr. 2019 Sep;212:79-86.e1. doi: 10.1016/j.jpeds.2019.04.059. Epub 2019 Jun 11. | |
| 18178784 |
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Blood, urine and stool samples
| PhenX Food Security & Prescription Accessibility |
This questionnaire will be used to describe the social determinants of health in the study population and their cross-sectional relationships with microvascular complications and macrovascular surrogates will largely be explored. |
| From enrollment to the end of the participant's participation or 4 weeks |
| Exercise and Substance Use | This questionnaire ask questions regarding participants' physical activity, sleeping habits and substance use. | From enrollment to the end of the participant's participation or 4 weeks |
| Pubertal Self-Assessment | A self-evaluation questionnaire to assess child's pubertal development. | From enrollment to the end of the participant's participation or 4 weeks |
| Beverage Questionnaire (BEVQ15) | A questionnaire that asks the frequency and amount of beverage intake for the past month. | From enrollment to the end of the participant's participation or 4 weeks |
| CFRD Care & Technology | This is a questionnaire that asks participants regarding their CFRD care and the technology they use to help them manage diabetes. | From enrollment to the end of the participant's participation or 4 weeks |
| Diabetes Management Experience | This is a questionnaire that asks how participants manage their diabetes for the past 12 months. | From enrollment to the end of the participant's participation or 4 weeks |
| Problem Areas in Diabetes (PAID) | Questionnaire that asks participants about possible diabetes-related issues they have experienced. | From enrollment to the end of the participant's participation or 4 weeks |
| Problem Areas in Diabetes Parents of Teens (P-PAID-T) | Questionnaire about what the parent or guardian of a participant may experience with their child's diabetes and rating how true it is for them over the past month. | From enrollment to the end of the participant's participation or 4 weeks |
| Hypoglycemia Fear Survey (Child) | A survey that consists of 25 questions and selecting from scale (0 = never to 4 = always) about how low blood sugar makes children feel and do. | From enrollment to the end of the participant's participation or 4 weeks |
| Hypoglycemia Fear Survey (Parent) | Survey that consists of 25 questions about the frequency of things parents of children with diabetes sometimes do to keep from having low blood sugar. | From enrollment to the end of the participant's participation or 4 weeks |
| Hypoglycemia Fear Survey (Adult-Short Form)/Worry (HFS-II-Worry) | A survey about various scenarios that may happen to the participant and rating how true it is for them over the past 6 months. | From enrollment to the end of the participant's participation or 4 weeks |
| Gold Score | A 7 item scale that measures hypoglycemia awareness | From enrollment to the end of the participant's participation or 4 weeks |
| All of Us | A questionnaire that consists of 14 questions asking about the participant, their work and their home life. | From enrollment to the end of the participant's participation or 4 weeks |
| Continuous glucose monitoring (CGM)-defined glycemic control (time-in-range, time-above-range, time-below-range, glucose variability), and the relationships between CGM metrics and HbA1c, in a diverse population of people with established CFRD | This will be measured using a continuous glucose monitor that will be worn by the participant for 3 to 10 days. | 3-10 days |
| Diversity of participants enrolled and barriers to enrollment | This will be measured using the patient-related outcomes questionnaires. | From enrollment to the end of the participant's participation or 4 weeks |
| Renal function by eGFR | Function will be assessed by collection of creatinine and Cystatin-C | From enrollment to the end of the participant's participation or 4 weeks |
| Liver function | This will be measured by liver enzymes and complete blood count (CBC); APRI and EMR data for liver imaging | From enrollment to the end of the participant's participation or 4 weeks |
| Cardiovascular sub-study - Pulse Wave Velocity and Pulse Wave Analysis (PWV & PWA) |
A Sphygmocor XCEL device will be used to measure PWV/PWA (m/sec), pulse pressure amplification and augmentation index (Aix) and Aix adjusted to a HR of 75 (Aix-75). |
| 1 study visit day |
| Exploratory Outcome - HbA1c and CGM metrics with nutritional intake | The participant will complete 3-day recall of food intake using NIH's Automated Self-Administered 24-Hour (ASA24) Dietary Assessment Tool. | 3 days |
| Exploratory Outcome - HbA1c and CGM metrics with physical activity | The participant will be required to wear an accelerometer device for 3 to 10 days to assess physical activity. | 3-10 days |
| Cardiovascular sub-study - Ambulatory Blood Pressure Monitoring | An oscillometric Spacelab monitors will be used to measure variables including SBP/DBP and BP load (%BP above 95th percentile for sex and height) for the 24-hour period and awake/sleep period. Sleep time will be determined from actigraphy and participant documentation. | 24 hours |
| Fecal Collection | Participant stool sample will be obtained for fecal elastase only for those for pancreatic sufficiency status is unclear. | From enrollment to the end of the participant's participation or 4 weeks |
| Sample Collection for Biorepository | Blood, urine and stool will be collected for biorepository. | From enrollment to the end of the participant's participation or 4 weeks |
| Information Collection for Geocoding | The study will use the participants' addresses or part of their addresses (such as their zip codes) to allow researchers to look at how where they live might be related to their health through geocoding. | from enrollment |
| Keck Medical Center of USC | Not yet recruiting | Los Angeles | California | 90033 | United States |
|
| Stanford University | Not yet recruiting | Palo Alto | California | 94304 | United States |
|
| University of California San Diego | Not yet recruiting | San Diego | California | 92103 | United States |
|
| University of Colorado Denver | Recruiting | Aurora | Colorado | 80045 | United States |
|
| University of Miami | Not yet recruiting | Miami | Florida | 33136 | United States |
|
| Emory University School of Medicine | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| University of Iowa | Not yet recruiting | Iowa City | Iowa | 52242 | United States |
|
| Tulane University | Not yet recruiting | New Orleans | Louisiana | 70112 | United States |
|
| Massachusetts | Not yet recruiting | Boston | Massachusetts | 02114 | United States |
|
| University of Minnesota | Recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| University of New Mexico | Not yet recruiting | Albuquerque | New Mexico | 87106 | United States |
|
| Columbia University Cystic Fibrosis Program | Not yet recruiting | New York | New York | 10032 | United States |
|
| Atrium Health Wake Forest Baptist (Wake Forest Baptist) | Not yet recruiting | Winston-Salem | North Carolina | 27104 | United States |
|
| The Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19146 | United States |
|
| Medical University of South Carolina | Not yet recruiting | Charlestone | South Carolina | 29425 | United States |
|
| Baylor College of Medicine | Not yet recruiting | Houston | Texas | 77030 | United States |
|
| The University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Background |
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| 38537890 | Background | Bergman M, Tuomilehto J. International Diabetes Federation Position Statement on the 1-hour post-load plasma glucose for the diagnosis of intermediate hyperglycaemia and type 2 diabetes. Diabetes Res Clin Pract. 2024 Apr;210:111636. doi: 10.1016/j.diabres.2024.111636. Epub 2024 Mar 25. No abstract available. |
| 38458916 | Background | Bergman M, Manco M, Satman I, Chan J, Schmidt MI, Sesti G, Vanessa Fiorentino T, Abdul-Ghani M, Jagannathan R, Kumar Thyparambil Aravindakshan P, Gabriel R, Mohan V, Buysschaert M, Bennakhi A, Pascal Kengne A, Dorcely B, Nilsson PM, Tuomi T, Battelino T, Hussain A, Ceriello A, Tuomilehto J. International Diabetes Federation Position Statement on the 1-hour post-load plasma glucose for the diagnosis of intermediate hyperglycaemia and type 2 diabetes. Diabetes Res Clin Pract. 2024 Mar;209:111589. doi: 10.1016/j.diabres.2024.111589. Epub 2024 Mar 7. |
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| 29398489 | Background | Eising JB, van der Ent CK, Teske AJ, Vanderschuren MM, Uiterwaal CSPM, Meijboom FJ. Young patients with cystic fibrosis demonstrate subtle alterations of the cardiovascular system. J Cyst Fibros. 2018 Sep;17(5):643-649. doi: 10.1016/j.jcf.2017.12.009. Epub 2018 Feb 3. |
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| 32482593 | Background | Karnsakul W, Wasuwanich P, Ingviya T, Vasilescu A, Carson KA, Mogayzel PJ, Schwarz KB. A longitudinal assessment of non-invasive biomarkers to diagnose and predict cystic fibrosis-associated liver disease. J Cyst Fibros. 2020 Jul;19(4):546-552. doi: 10.1016/j.jcf.2020.05.002. Epub 2020 May 30. |
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| 29133356 | Background | Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018 Jun;71(6):e13-e115. doi: 10.1161/HYP.0000000000000065. Epub 2017 Nov 13. No abstract available. |
| 35078371 | Background | Tsao CW, Aday AW, Almarzooq ZI, Alonso A, Beaton AZ, Bittencourt MS, Boehme AK, Buxton AE, Carson AP, Commodore-Mensah Y, Elkind MSV, Evenson KR, Eze-Nliam C, Ferguson JF, Generoso G, Ho JE, Kalani R, Khan SS, Kissela BM, Knutson KL, Levine DA, Lewis TT, Liu J, Loop MS, Ma J, Mussolino ME, Navaneethan SD, Perak AM, Poudel R, Rezk-Hanna M, Roth GA, Schroeder EB, Shah SH, Thacker EL, VanWagner LB, Virani SS, Voecks JH, Wang NY, Yaffe K, Martin SS. Heart Disease and Stroke Statistics-2022 Update: A Report From the American Heart Association. Circulation. 2022 Feb 22;145(8):e153-e639. doi: 10.1161/CIR.0000000000001052. Epub 2022 Jan 26. |
| 33705304 | Background | Khosla L, Bhat S, Fullington LA, Horlyck-Romanovsky MF. HbA1c Performance in African Descent Populations in the United States With Normal Glucose Tolerance, Prediabetes, or Diabetes: A Scoping Review. Prev Chronic Dis. 2021 Mar 11;18:E22. doi: 10.5888/pcd18.200365. |
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| 27241975 | Background | Lado JJ, Lipman TH. Racial and Ethnic Disparities in the Incidence, Treatment, and Outcomes of Youth with Type 1 Diabetes. Endocrinol Metab Clin North Am. 2016 Jun;45(2):453-61. doi: 10.1016/j.ecl.2016.01.002. Epub 2016 Apr 7. |
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| 25687140 | Background | Willi SM, Miller KM, DiMeglio LA, Klingensmith GJ, Simmons JH, Tamborlane WV, Nadeau KJ, Kittelsrud JM, Huckfeldt P, Beck RW, Lipman TH; T1D Exchange Clinic Network. Racial-ethnic disparities in management and outcomes among children with type 1 diabetes. Pediatrics. 2015 Mar;135(3):424-34. doi: 10.1542/peds.2014-1774. |
| 24582008 | Background | Valenzuela JM, Seid M, Waitzfelder B, Anderson AM, Beavers DP, Dabelea DM, Dolan LM, Imperatore G, Marcovina S, Reynolds K, Yi-Frazier J, Mayer-Davis EJ; SEARCH for Diabetes in Youth Study Group. Prevalence of and disparities in barriers to care experienced by youth with type 1 diabetes. J Pediatr. 2014 Jun;164(6):1369-75.e1. doi: 10.1016/j.jpeds.2014.01.035. Epub 2014 Feb 25. |
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| 19246575 | Background | Bell RA, Mayer-Davis EJ, Beyer JW, D'Agostino RB Jr, Lawrence JM, Linder B, Liu LL, Marcovina SM, Rodriguez BL, Williams D, Dabelea D; SEARCH for Diabetes in Youth Study Group. Diabetes in non-Hispanic white youth: prevalence, incidence, and clinical characteristics: the SEARCH for Diabetes in Youth Study. Diabetes Care. 2009 Mar;32 Suppl 2(Suppl 2):S102-11. doi: 10.2337/dc09-S202. |
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| 34427600 | Background | Lawrence JM, Divers J, Isom S, Saydah S, Imperatore G, Pihoker C, Marcovina SM, Mayer-Davis EJ, Hamman RF, Dolan L, Dabelea D, Pettitt DJ, Liese AD; SEARCH for Diabetes in Youth Study Group. Trends in Prevalence of Type 1 and Type 2 Diabetes in Children and Adolescents in the US, 2001-2017. JAMA. 2021 Aug 24;326(8):717-727. doi: 10.1001/jama.2021.11165. |
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| 36812420 | Background | Perng W, Conway R, Mayer-Davis E, Dabelea D. Youth-Onset Type 2 Diabetes: The Epidemiology of an Awakening Epidemic. Diabetes Care. 2023 Mar 1;46(3):490-499. doi: 10.2337/dci22-0046. |
| 33581191 | Background | Falkner B, Gidding S. Life-Course Implications of Pediatric Risk Factors for Cardiovascular Disease. Can J Cardiol. 2021 May;37(5):766-775. doi: 10.1016/j.cjca.2021.02.001. Epub 2021 Feb 11. |
| 38078591 | Background | American Diabetes Association Professional Practice Committee. 4. Comprehensive Medical Evaluation and Assessment of Comorbidities: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S52-S76. doi: 10.2337/dc24-S004. |
| 38078582 | Background | American Diabetes Association Professional Practice Committee. 14. Children and Adolescents: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S258-S281. doi: 10.2337/dc24-S014. |
| 25902357 | Background | Misra A. Ethnic-Specific Criteria for Classification of Body Mass Index: A Perspective for Asian Indians and American Diabetes Association Position Statement. Diabetes Technol Ther. 2015 Sep;17(9):667-71. doi: 10.1089/dia.2015.0007. Epub 2015 Apr 22. |
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| 21115772 | Background | Moran A, Brunzell C, Cohen RC, Katz M, Marshall BC, Onady G, Robinson KA, Sabadosa KA, Stecenko A, Slovis B; CFRD Guidelines Committee. Clinical care guidelines for cystic fibrosis-related diabetes: a position statement of the American Diabetes Association and a clinical practice guideline of the Cystic Fibrosis Foundation, endorsed by the Pediatric Endocrine Society. Diabetes Care. 2010 Dec;33(12):2697-708. doi: 10.2337/dc10-1768. No abstract available. |
| 37474158 | Background | Frost F, Nazareth D, Fauchier L, Wat D, Shelley J, Austin P, Walshaw MJ, Lip GYH. Prevalence, risk factors and outcomes of cardiac disease in cystic fibrosis: a multinational retrospective cohort study. Eur Respir J. 2023 Oct 26;62(4):2300174. doi: 10.1183/13993003.00174-2023. Print 2023 Oct. |
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| 30711385 | Background | Colomba J, Boudreau V, Lehoux-Dubois C, Desjardins K, Coriati A, Tremblay F, Rabasa-Lhoret R. The main mechanism associated with progression of glucose intolerance in older patients with cystic fibrosis is insulin resistance and not reduced insulin secretion capacity. J Cyst Fibros. 2019 Jul;18(4):551-556. doi: 10.1016/j.jcf.2019.01.009. Epub 2019 Jan 30. |
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| 23670970 | Background | Blackman SM, Commander CW, Watson C, Arcara KM, Strug LJ, Stonebraker JR, Wright FA, Rommens JM, Sun L, Pace RG, Norris SA, Durie PR, Drumm ML, Knowles MR, Cutting GR. Genetic modifiers of cystic fibrosis-related diabetes. Diabetes. 2013 Oct;62(10):3627-35. doi: 10.2337/db13-0510. Epub 2013 May 13. |
| 31697830 | Background | Aksit MA, Pace RG, Vecchio-Pagan B, Ling H, Rommens JM, Boelle PY, Guillot L, Raraigh KS, Pugh E, Zhang P, Strug LJ, Drumm ML, Knowles MR, Cutting GR, Corvol H, Blackman SM. Genetic Modifiers of Cystic Fibrosis-Related Diabetes Have Extensive Overlap With Type 2 Diabetes and Related Traits. J Clin Endocrinol Metab. 2020 May 1;105(5):1401-15. doi: 10.1210/clinem/dgz102. |
| 38075070 | Background | Malik SS, Padmanabhan D, Hull-Meichle RL. Pancreas and islet morphology in cystic fibrosis: clues to the etiology of cystic fibrosis-related diabetes. Front Endocrinol (Lausanne). 2023 Nov 23;14:1269139. doi: 10.3389/fendo.2023.1269139. eCollection 2023. |
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| 26132840 | Background | Sawicki GS, McKone EF, Pasta DJ, Millar SJ, Wagener JS, Johnson CA, Konstan MW. Sustained Benefit from ivacaftor demonstrated by combining clinical trial and cystic fibrosis patient registry data. Am J Respir Crit Care Med. 2015 Oct 1;192(7):836-42. doi: 10.1164/rccm.201503-0578OC. |
| 27898234 | Background | Rowe SM, McColley SA, Rietschel E, Li X, Bell SC, Konstan MW, Marigowda G, Waltz D, Boyle MP; VX09-809-102 Study Group. Lumacaftor/Ivacaftor Treatment of Patients with Cystic Fibrosis Heterozygous for F508del-CFTR. Ann Am Thorac Soc. 2017 Feb;14(2):213-219. doi: 10.1513/AnnalsATS.201609-689OC. |
| 29099333 | Background | Rowe SM, Daines C, Ringshausen FC, Kerem E, Wilson J, Tullis E, Nair N, Simard C, Han L, Ingenito EP, McKee C, Lekstrom-Himes J, Davies JC. Tezacaftor-Ivacaftor in Residual-Function Heterozygotes with Cystic Fibrosis. N Engl J Med. 2017 Nov 23;377(21):2024-2035. doi: 10.1056/NEJMoa1709847. Epub 2017 Nov 3. |
| 22047557 | Background | Ramsey BW, Davies J, McElvaney NG, Tullis E, Bell SC, Drevinek P, Griese M, McKone EF, Wainwright CE, Konstan MW, Moss R, Ratjen F, Sermet-Gaudelus I, Rowe SM, Dong Q, Rodriguez S, Yen K, Ordonez C, Elborn JS; VX08-770-102 Study Group. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N Engl J Med. 2011 Nov 3;365(18):1663-72. doi: 10.1056/NEJMoa1105185. |
| 34784492 | Background | Nichols DP, Paynter AC, Heltshe SL, Donaldson SH, Frederick CA, Freedman SD, Gelfond D, Hoffman LR, Kelly A, Narkewicz MR, Pittman JE, Ratjen F, Rosenfeld M, Sagel SD, Schwarzenberg SJ, Singh PK, Solomon GM, Stalvey MS, Clancy JP, Kirby S, Van Dalfsen JM, Kloster MH, Rowe SM; PROMISE Study group. Clinical Effectiveness of Elexacaftor/Tezacaftor/Ivacaftor in People with Cystic Fibrosis: A Clinical Trial. Am J Respir Crit Care Med. 2022 Mar 1;205(5):529-539. doi: 10.1164/rccm.202108-1986OC. |
| 31697873 | Background | Middleton PG, Mall MA, Drevinek P, Lands LC, McKone EF, Polineni D, Ramsey BW, Taylor-Cousar JL, Tullis E, Vermeulen F, Marigowda G, McKee CM, Moskowitz SM, Nair N, Savage J, Simard C, Tian S, Waltz D, Xuan F, Rowe SM, Jain R; VX17-445-102 Study Group. Elexacaftor-Tezacaftor-Ivacaftor for Cystic Fibrosis with a Single Phe508del Allele. N Engl J Med. 2019 Nov 7;381(19):1809-1819. doi: 10.1056/NEJMoa1908639. Epub 2019 Oct 31. |
| 31679946 | Background | Heijerman HGM, McKone EF, Downey DG, Van Braeckel E, Rowe SM, Tullis E, Mall MA, Welter JJ, Ramsey BW, McKee CM, Marigowda G, Moskowitz SM, Waltz D, Sosnay PR, Simard C, Ahluwalia N, Xuan F, Zhang Y, Taylor-Cousar JL, McCoy KS; VX17-445-103 Trial Group. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial. Lancet. 2019 Nov 23;394(10212):1940-1948. doi: 10.1016/S0140-6736(19)32597-8. Epub 2019 Oct 31. |
| 23590265 | Background | Davies JC, Wainwright CE, Canny GJ, Chilvers MA, Howenstine MS, Munck A, Mainz JG, Rodriguez S, Li H, Yen K, Ordonez CL, Ahrens R; VX08-770-103 (ENVISION) Study Group. Efficacy and safety of ivacaftor in patients aged 6 to 11 years with cystic fibrosis with a G551D mutation. Am J Respir Crit Care Med. 2013 Jun 1;187(11):1219-25. doi: 10.1164/rccm.201301-0153OC. |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D003920 | Diabetes Mellitus |
| D012164 | Retinal Diseases |
| D007674 | Kidney Diseases |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005128 | Eye Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
Not provided
Not provided