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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05568134
Other study ID # 22-020249
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 17, 2023
Est. completion date February 1, 2026

Study information

Verified date March 2024
Source Children's Hospital of Philadelphia
Contact Grey Baker
Phone (215)-590-3174
Email bakerg3@chop.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date February 1, 2026
Est. primary completion date February 1, 2025
Accepts healthy volunteers No
Gender All
Age group 10 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Fasting glucose before OGTT
Primary 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. 1 hour mark in OGTT
Primary 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. 2 hour mark in OGTT
Secondary 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. Up to 2 hours
Secondary Difference between plasma glucose and CGM measured glucose after the fasting glucose Absolute differences between the glucose measurements will be measured in mg/dL Up to 20 minutes after the fasting glucose
Secondary 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 Up to 20 minutes after the 1 hour mark in the OGTT
Secondary 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 Up to 20 minutes after the 2 hour mark in the OGTT
Secondary 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. Up to 2 hours
Secondary 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 Within 2 weeks after removal of the CGM
Secondary 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). Within 2 weeks after removal of the CGM
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