Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-02-26 @ 11:53 PM
Study NCT ID:
NCT02211235
Status:
COMPLETED
Last Update Posted:
2023-03-22
First Post:
2014-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glycemic Monitoring in Cystic Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Alternative markers of glycemia, including fructosamine, glycated albumin, and 1,5-anhydroglucitol, Oral Glucose Tolerance Test (OGTT) derived markers of insulin secretion and insulin sensitivity'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 146}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-20', 'studyFirstSubmitDate': '2014-07-29', 'studyFirstSubmitQcDate': '2014-08-05', 'lastUpdatePostDateStruct': {'date': '2023-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in CGM variables and BMI', 'timeFrame': '3 years', 'description': 'To analyze in youth with CF the relationship between CGM variables and BMI Primary outcome: Change in BMI z-score collected at routine clinical visits over the preceding three years'}, {'measure': 'Change in CGM variables and lung function', 'timeFrame': '3 years', 'description': 'To analyze in youth with CF the relationship between CGM variables and lung function change in the preceding three years Secondary outcome: Change in forced expiratory volume at one second (FEV1) and forced vital capacity (FVC) measures collected at routine clinical visits over the preceding three years'}, {'measure': 'Characterize the relationships between markers of glycemia', 'timeFrame': '3 days', 'description': 'To characterize the relationships between alternative markers of glycemia (fructosamine, glycated albumin, and 1,5-anhydroglucitol) and CGM variables in non-diabetic CF youth and healthy controls'}], 'primaryOutcomes': [{'measure': 'The percentage of time spent > 140 mg/dl on CGM', 'timeFrame': '7 days', 'description': 'Percentage of time above normal glucose cut-point.'}], 'secondaryOutcomes': [{'measure': 'The percentage of time spent > 120 mg/dl on CGM', 'timeFrame': '7 days', 'description': 'Measures of glucose variability on CGM'}, {'measure': 'The percentage of time spent > 200 mg/dl on CGM', 'timeFrame': '7 days', 'description': 'Measures of glucose variability on CGM'}, {'measure': 'The percentage of time spent < 70 mg/dl on CGM', 'timeFrame': '7 days', 'description': 'Measures of glucose variability on CGM'}, {'measure': 'The percentage of time spent < 60 mg/dl on CGM', 'timeFrame': '7 days', 'description': 'Measures of glucose variability on CGM'}, {'measure': 'The number of excursions > 200mg/dl in 24 hours for one week', 'timeFrame': '7 days', 'description': 'Measures of glucose variability including peak glucose, mean glucose and measures of glucose variability on CGM.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cystic Fibrosis', 'Healthy Controls', 'Diabetes', 'Cystic Fibrosis Related Diabetes (CFRD)', 'CFRD'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '34537845', 'type': 'DERIVED', 'citation': 'Chan CL, Pyle L, Vigers T, Zeitler PS, Nadeau KJ. The Relationship Between Continuous Glucose Monitoring and OGTT in Youth and Young Adults With Cystic Fibrosis. J Clin Endocrinol Metab. 2022 Jan 18;107(2):e548-e560. doi: 10.1210/clinem/dgab692.'}, {'pmid': '32928701', 'type': 'DERIVED', 'citation': 'Tommerdahl KL, Brinton JT, Vigers T, Cree-Green M, Zeitler PS, Nadeau KJ, Chan CL. Delayed glucose peak and elevated 1-hour glucose on the oral glucose tolerance test identify youth with cystic fibrosis with lower oral disposition index. J Cyst Fibros. 2021 Mar;20(2):339-345. doi: 10.1016/j.jcf.2020.08.020. Epub 2020 Sep 11.'}, {'pmid': '29674323', 'type': 'DERIVED', 'citation': 'Chan CL, Hope E, Thurston J, Vigers T, Pyle L, Zeitler PS, Nadeau KJ. Hemoglobin A1c Accurately Predicts Continuous Glucose Monitoring-Derived Average Glucose in Youth and Young Adults With Cystic Fibrosis. Diabetes Care. 2018 Jul;41(7):1406-1413. doi: 10.2337/dc17-2419. Epub 2018 Apr 19.'}]}, 'descriptionModule': {'briefSummary': "Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes recommend treatment for diabetes based on diagnostic criteria derived from adults with type 2 diabetes. Increasing evidence supports treating early glucose abnormalities in cystic fibrosis patients to target CF specific outcomes, including lung function and nutrition (BMI-Body Mass Index). However, the criteria and timing of when to start insulin therapy in the 'prediabetic' state are unclear. A more accurate characterization of blood sugar variability in youth with and without CF will help the investigators better interpret continuous glucose monitor (CGM) findings in patients with CF prediabetes and diabetes and more accurately identify those individuals at greatest risk for disease progression."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children and Adolescents ages 6-25, without diabetes. Out of 160 people, 45 will be healthy controls, 45 with Cystic Fibrosis (normal glucose tolerance), and 70 with Cystic Fibrosis-related diabetes or pre-diabetes.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy controls (n=45) -\n\n1. Age 10-25 years\n2. BMI \\<85th percentile\n3. Baseline health at enrollment\n\nCF controls (n=45) -\n\n1. Age 10-25 years\n2. Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing)\n3. Baseline health at enrollment (no inclusion/exclusion criteria for CF patients based on lung function, BMI, pancreatic insufficiency, or genotype)\n\nCF prediabetes \\& CFRD (n=70)\n\n1. Age 10-25 years\n2. Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing)\n3. History of abnormal oral glucose tolerance testing (2h-glucose \\>140, fasting plasma glucose \\>100,1hr glucose \\>200)\n4. If taking medication that affects glucose metabolism (ex. Insulin, insulin sensitizers, glucocorticoids, atypical antipsychotics), should be on a stable dose over the past 3 months\n\nExclusion Criteria:\n\nHealthy controls -\n\n1. Known diagnosis of diabetes or prediabetes (including type 1, type 2, MODY), abnormal oral glucose tolerance test (OGTT) (ie. fasting plasma glucose ≥100 or 2hr ≥140 mg/dl) or HbA1c ≥ 5.7%\n2. BMI ≥85th percentile\n3. Chronic disease that may affect glucose metabolism or use of medications affecting glucose metabolism in the past 3 months (ex. Insulin, insulin sensitizers, glucocorticoids, atypical antipsychotics)\n4. Presence of type 1 diabetes auto-antibodies in any individuals with a first degree relative with type 1 diabetes (will only include first degree relatives if they have had previous negative auto-antibody screening performed as part of participation in other studies such as the Trial Net studies at the Barbara Davis Center)\n5. Acute illness (ex. Asthma exacerbation, gastroenteritis, febrile illness)\n6. Pregnancy\n\nCF participants -\n\n1. Diagnosis of type 1 diabetes, type 2 diabetes, or MODY\n2. Varying doses of medication affecting glucose metabolism in the past 3 months\n3. Pulmonary exacerbation associated with hospitalization, or systemic steroid requirement in the preceding 6 weeks\n4. Pregnancy'}, 'identificationModule': {'nctId': 'NCT02211235', 'acronym': 'GEM', 'briefTitle': 'Glycemic Monitoring in Cystic Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Characterization of Glucose Variability by Continuous Glucose Monitoring in Non-diabetic Youth With and Without Cystic Fibrosis', 'orgStudyIdInfo': {'id': '14-0960'}, 'secondaryIdInfos': [{'id': 'UL1TR001082', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR001082', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado, University of Colorado Denver", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Christine L Chan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}