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NCT05607576 Clinical Trial

Dexcom G6 for Total Pancreatectomy With Islet Autotransplantation (TPIAT) Patients

Diabetes Clinical Trial

Official title:
Accuracy of Dexcom G6 After Radiation Exposure-A Cross Sectional and Longitudinal Analysis

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05607576
Other study ID # 2021-0838
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date May 2024

Study information
Verified date February 2024
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A single-center prospective trial on the effects of standard of care radiation exposure on the Dexcom G6 continuous glucose monitoring (CGM) device.

Description:

To determine if standard of care radiation exposure longitudinally effects the accuracy and precision of the G6 transmitter in the post TPIAT in-patient population. Reduce burden for patients to remove and waste a functional and expensive Dexcom G6 CGM for radiologic procedures.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date May 2024
Est. primary completion date October 20, 2023
Accepts healthy volunteers No
Gender All
Age group 11 Years to 25 Years
Eligibility Inclusion Criteria: - Planned TPIAT at CCHMC - Staying in-patient at CCHMC post TPIAT - Planned to receive a Dexcom G6 CGM Exclusion Criteria: • Hemo- or peritoneal dialysis

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Uncovered CGM during radiologic procedures
Dexcom G6 CGM will not be covered during radiologic procedures.

Locations
Country Name City State
United States Cincinnati Children's Hospital Medical Center Cincinnati Ohio

Sponsors (2)
Lead Sponsor Collaborator
Deborah Elder DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dexcom G6 accuracy post radiation exposure Dexcom G6 transmitter readings will be compared to glucometer readings until the transmitter is changed. 3 months
Primary Post radiation Dexcom G6 transmitter functional duration Data will be collected on participant procedures resulting in radiation exposure and transmitter change date. 3 months
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