Continuous Glucose Monitoring in Controls With and Without Cystic Fibrosis



Status:Recruiting
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:6 - 25
Updated:12/29/2018
Start Date:August 2014
End Date:December 2019
Contact:Christine L Chan, MD
Email:christinel.chan@childrenscolorado.org
Phone:720-777-6128

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Trial Summary
Trial Overview
Inclusion Criteria

Characterization of Glucose Variability by Continuous Glucose Monitoring in Non-diabetic Youth With and Without Cystic Fibrosis

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.


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

Exclusion Criteria:

Healthy controls -

1. 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%

2. BMI ≥85th percentile

3. 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)

4. 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)

5. Acute illness (ex. Asthma exacerbation, gastroenteritis, febrile illness)

6. Pregnancy

CF participants -

1. Diagnosis of type 1 diabetes, type 2 diabetes, or MODY

2. Varying doses of medication affecting glucose metabolism in the past 3 months

3. Pulmonary exacerbation associated with hospitalization, or systemic steroid
requirement in the preceding 6 weeks

4. Pregnancy
We found this trial at
1
site
Children's Hospital Colorado, University of Colorado Denver
Aurora, Colorado 80045
Principal Investigator: Christine L Chan, MD
Phone: 720-777-4354
?
mi
from
Aurora, CO
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