Glycemic Monitoring in Cystic Fibrosis

NCT02211235 | Completed

• 2 other identifiers: 14-0960UL1TR001082
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

Cystic Fibrosis; Healthy Controls; Diabetes; Cystic Fibrosis Related Diabetes (CFRD); CFRD

Outcome Measures

Primary Outcomes (1)

• The percentage of time spent > 140 mg/dl on CGM

  Percentage of time above normal glucose cut-point.

  7 days

Secondary Outcomes (5)

• The percentage of time spent > 120 mg/dl on CGM

  7 days

• The percentage of time spent > 200 mg/dl on CGM

  7 days

• The percentage of time spent < 70 mg/dl on CGM

  7 days

• The percentage of time spent < 60 mg/dl on CGM

  7 days

• The number of excursions > 200mg/dl in 24 hours for one week

  7 days

Other Outcomes (3)

• Change in CGM variables and BMI

  3 years

• Change in CGM variables and lung function

  3 years

• Characterize the relationships between markers of glycemia

  3 days

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Healthy controls (n=45) -
• Age 10-25 years
• BMI \<85th percentile
• Baseline health at enrollment
• CF controls (n=45) -
• Age 10-25 years
• Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing)

You may not qualify if:

• CF prediabetes \& CFRD (n=70)
• Age 10-25 years
• Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing)
• History of abnormal oral glucose tolerance testing (2h-glucose \>140, fasting plasma glucose \>100,1hr glucose \>200)
• 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
• Healthy controls -
• 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%
• BMI ≥85th percentile
• 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)
• 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)
• Acute illness (ex. Asthma exacerbation, gastroenteritis, febrile illness)
• Pregnancy
• CF participants -
• Diagnosis of type 1 diabetes, type 2 diabetes, or MODY
• Varying doses of medication affecting glucose metabolism in the past 3 months

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

Children's Hospital Colorado, University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

Related Publications (3)

• 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.

  PMID: 34537845 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.

  PMID: 32928701 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.

  PMID: 29674323 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Cystic Fibrosis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christine L Chan, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2014
• First Posted: August 7, 2014
• Study Start: August 1, 2014
• Primary Completion: May 16, 2018
• Study Completion: May 16, 2018
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

US (1)