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Completed

NCT Number: NCT02211235

Glycemic Monitoring in 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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)
  • 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)

  • 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

Exclusion criteria

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
  • Pulmonary exacerbation associated with hospitalization, or systemic steroid requirement in the preceding 6 weeks
  • Pregnancy

Treatment and study plan

Primary outcomes

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

    Time frame: 7 days

    Percentage of time above normal glucose cut-point.

Secondary outcomes

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

    Time frame: 7 days

    Measures of glucose variability on CGM

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

    Time frame: 7 days

    Measures of glucose variability on CGM

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

    Time frame: 7 days

    Measures of glucose variability on CGM

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

    Time frame: 7 days

    Measures of glucose variability on CGM

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

    Time frame: 7 days

    Measures of glucose variability including peak glucose, mean glucose and measures of glucose variability on CGM.

Other outcomes

  1. Change in CGM variables and BMI

    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

  2. Change in CGM variables and lung function

    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

  3. Characterize the relationships between markers of glycemia

    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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Acronym: GEM

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Aug 7, 2014
Registry last updated
Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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