Cystic Fibrosis
Conditions
Keywords
Cystic Fibrosis, Healthy Controls, Diabetes, Cystic Fibrosis Related Diabetes (CFRD), CFRD
Brief summary
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.
Interventions
None listed
Sponsors
University of Colorado, Denver
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy controls (n=45) - 1. Age 10-25 years 2. BMI \<85th percentile 3. Baseline health at enrollment CF controls (n=45) - 1. Age 10-25 years 2. Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing) 3. Baseline health at enrollment (no inclusion/
Exclusion criteria
for CF patients based on lung function, BMI, pancreatic insufficiency, or genotype) CF prediabetes & CFRD (n=70) 1. Age 10-25 years 2. Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing) 3. History of abnormal oral glucose tolerance testing (2h-glucose \>140, fasting plasma glucose \>100,1hr glucose \>200) 4. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of time spent > 140 mg/dl on CGM | 7 days | Percentage of time above normal glucose cut-point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of time spent > 200 mg/dl on CGM | 7 days | Measures of glucose variability on CGM |
| The percentage of time spent < 70 mg/dl on CGM | 7 days | Measures of glucose variability on CGM |
| The percentage of time spent < 60 mg/dl on CGM | 7 days | Measures of glucose variability on CGM |
| The number of excursions > 200mg/dl in 24 hours for one week | 7 days | Measures of glucose variability including peak glucose, mean glucose and measures of glucose variability on CGM. |
| The percentage of time spent > 120 mg/dl on CGM | 7 days | Measures of glucose variability on CGM |
Other
| Measure | Time frame | Description |
|---|---|---|
| Characterize the relationships between markers of glycemia | 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 |
| Change in CGM variables and lung function | 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 |
| Change in CGM variables and BMI | 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 |
Countries
United States
Outcome results
None listed