Glycemic Monitoring in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— GEM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211235
• Other study ID #: 14-0960
• Secondary ID: UL1TR001082
• Status: Completed
• Start date: August 2014
• Est. completion date: May 16, 2018

Study information

• Verified date: March 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: May 16, 2018
• Est. primary completion date: May 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Locations

Country	Name	City	State
United States	Children's Hospital Colorado, University of Colorado Denver	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Change in CGM variables and lung function	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
Other	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
Primary	The percentage of time spent > 140 mg/dl on CGM	Percentage of time above normal glucose cut-point.	7 days
Secondary	The percentage of time spent > 120 mg/dl on CGM	Measures of glucose variability on CGM	7 days
Secondary	The percentage of time spent > 200 mg/dl on CGM	Measures of glucose variability on CGM	7 days
Secondary	The percentage of time spent < 70 mg/dl on CGM	Measures of glucose variability on CGM	7 days
Secondary	The percentage of time spent < 60 mg/dl on CGM	Measures of glucose variability on CGM	7 days
Secondary	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