An observational study in Cystic Fibrosis and Cystic Fibrosis-related Diabetes, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2025-02-24.
Sponsored by Children's Hospital of Philadelphia · Observational
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.
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 14 is below the median of 85 across 482 observational studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
A total of 15 subjects with cystic fibrosis (CF) over 10 years of age will be approached to participate.
Exclusion Criteria:
All enrolled participants will complete an OGTT.
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.
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose
Differences in fasting glucose will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose.
Time frame: Fasting glucose before OGTT
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose
Differences in the 1 hour glucose during the OGTT will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose.
Time frame: 1 hour mark in OGTT
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose
Differences in the 2 hour glucose during the OGTT will be measured by the difference in mg/dl between plasma glucose, CGM measured glucose, and GTT@home measured glucose.
Time frame: 2 hour mark in OGTT
Agreement between the categorical diagnosis of normal glucose tolerance (NGT), impaired glucose tolerance (IGT), indeterminate glycemia (INDET), and CFRD as defined by plasma glucose, CGM glucose, and GTT@home glucose.
Categorical diagnosis of glucose tolerance as measured by plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose.
Time frame: Up to 2 hours
Difference between plasma glucose and CGM measured glucose after the fasting glucose
Absolute differences between the glucose measurements will be measured in mg/dL
Time frame: Up to 20 minutes after the fasting glucose
Difference between plasma glucose and CGM measured glucose after the 1 hour mark during the OGTT.
Absolute differences between the glucose measurements will be measured in mg/dL
Time frame: Up to 20 minutes after the 1 hour mark in the OGTT
Difference between plasma glucose and CGM measured glucose after the 2 hour mark during the OGTT.
Absolute differences between the glucose measurements will be measured in mg/dL
Time frame: Up to 20 minutes after the 2 hour mark in the OGTT
The ability of untrained participants to successfully complete the GTT@home kit without any guidance from the research team
Number of steps successfully completed as measured by the GTT@home instruction manual.
Time frame: Up to 2 hours
Impact of wearing a real-time CGM on participants' awareness of the importance of screening for and diagnosing CFRD.
60 minute semi-structured interviews will be conducted with participants. Transcripts will be analyzed using semantic content analysis
Time frame: Within 2 weeks after removal of the CGM
Perceived benefits and burdens of CGM use
Participants will complete a CGM Benefits and Burdens survey, a 16-item measure used to assess perceptions of CGM technology in people with type 1 diabetes. Surveys may be completed on paper or online, as per the participant's preference. The survey is scored on a 5-point scale (agree/disagree scale).
Time frame: Within 2 weeks after removal of the CGM
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia