NCT05568134

Alternate Measures of Glucose During OGTT Testing for CFRD

Correlations Between CGM and Serum Glucose During OGTT Testing for CFRD

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 14 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Cystic Fibrosis
• Cystic Fibrosis-related Diabetes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Oral glucose tolerance test	An oral glucose tolerance test will be completed. A fasting glucose will be measured. Participants will drink 1.75 g/kg of dextrose (up to a maximum of 75 grams) within 10 minutes. Glucose values will be measured at 1 hour and 2 hours.

Timeline

• Start date: 2023-07-17
• Primary completion: 2024-12-13
• Completion: 2024-12-13
• First posted: 2022-10-05
• Last updated: 2025-02-24

Locations

1 site across 1 country: United States