Alternate Measures of Glucose During OGTT Testing for CFRD

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Cystic Fibrosis-related Diabetes; Cystic Fibrosis

Treatments: Diagnostic Test: Oral glucose tolerance test

Study type: Observational

Funder types: Other

Identifiers

NCT05568134

22-020249

Details and patient eligibility

About

Although early detection and treatment of cystic fibrosis-related diabetes (CFRD) can lead to significant clinical improvements and prolong life, rates of screening are poor likely due to the burdensome nature of oral glucose tolerance testing (OGTT). The investigators propose to assess the feasibility and accuracy of two screening tools, continuous glucose monitoring (CGM) and a home OGTT kit (GTT@home). If this pilot study reveals acceptable accuracy of either device, this study will allow for future studies exploring home-based OGTT screening.

Full description

The investigators hypothesize that there will be strong agreement between plasma glucose and glucose as measured by either CGM or GTT@home at three different timepoints during an OGTT: fasting, 1-hour, and 2-hours.

Enrollment: 14 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of cystic fibrosis
• ≥ 10 years of age
• Fluency in written and spoken English as the GTT@Home is currently only available in English

Exclusion criteria

• Hospitalization or treatment with IV antibiotics or supraphysiologic glucocorticoids within 4 weeks
• Major medical or psychiatric disorders other than CF
• Use of medications known to impact the accuracy of the Dexcom G7 (hydroxyurea, >2g acetaminophen per day)
• History of severe adhesive reactions that may lead to an inability to tolerate CGM wear

Trial design

14 participants in 1 patient group

OGTT Cohort

Description:

All enrolled participants will complete an OGTT.

Treatment:

Diagnostic Test: Oral glucose tolerance test