Alternate Measures of Glucose During OGTT Testing for CFRD

NCT ID: NCT05568134

Last Updated: 2025-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-17

Study Completion Date

2024-12-13

Brief Summary

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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

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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

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Cystic Fibrosis Cystic Fibrosis-related Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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OGTT Cohort

All enrolled participants will complete an OGTT.

Oral glucose tolerance test

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cystic Fibrosis Foundation

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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22-020249

Identifier Type: -

Identifier Source: org_study_id

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