Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001082 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of time spent > 140 mg/dl on CGM | Percentage of time above normal glucose cut-point. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of time spent > 120 mg/dl on CGM | Measures of glucose variability on CGM | 7 days |
| The percentage of time spent > 200 mg/dl on CGM | Measures of glucose variability on CGM |
| Measure | Description | Time Frame |
|---|---|---|
| Change in CGM variables and BMI | 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 | 3 years |
| Change in CGM variables and lung function |
Inclusion Criteria:
Healthy controls (n=45) -
CF controls (n=45) -
CF prediabetes & CFRD (n=70)
Exclusion Criteria:
Healthy controls -
CF participants -
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christine L Chan, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado, University of Colorado Denver | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34537845 | Derived | 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. | |
| 32928701 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
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
| 7 days |
| The percentage of time spent < 70 mg/dl on CGM | Measures of glucose variability on CGM | 7 days |
| The percentage of time spent < 60 mg/dl on CGM | Measures of glucose variability on CGM | 7 days |
| The number of excursions > 200mg/dl in 24 hours for one week | Measures of glucose variability including peak glucose, mean glucose and measures of glucose variability on CGM. | 7 days |
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 |
| 3 years |
| Characterize the relationships between markers of glycemia | 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 | 3 days |
| 29674323 | Derived | 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. |
| 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 |