Children's Hospital Colorado, University of Colorado Denver
Aurora, Colorado, 80045, United States
NCT Number: NCT02211235
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.
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Notify Me6 year–25 year
All sexes
Observational
Aurora, Colorado, 80045, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Healthy controls (n=45) -
CF controls (n=45) -
CF prediabetes & CFRD (n=70)
Exclusion criteria
Healthy controls -
CF participants -
Time frame: 7 days
Percentage of time above normal glucose cut-point.
Time frame: 7 days
Measures of glucose variability on CGM
Time frame: 7 days
Measures of glucose variability on CGM
Time frame: 7 days
Measures of glucose variability on CGM
Time frame: 7 days
Measures of glucose variability on CGM
Time frame: 7 days
Measures of glucose variability including peak glucose, mean glucose and measures of glucose variability on CGM.
Time frame: 3 years
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
Time frame: 3 years
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
Time frame: 3 days
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
University of Colorado, Denver
Other
Characterization of Glucose Variability by Continuous Glucose Monitoring in Non-diabetic Youth With and Without Cystic Fibrosis
Acronym: GEM
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