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

Sponsor

Deborah Elder (Other)

Overall Status

Recruiting

CT.gov ID

NCT05607576

Collaborator

DexCom, Inc. (Industry)

Enrollment

Location

Arm

33.1

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Other: Uncovered CGM during radiologic procedures	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

This study is not blinded

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Uncovered Dexcom G6 CGM will be uncovered during standard of care radiologic procedures.	Other: Uncovered CGM during radiologic procedures Dexcom G6 CGM will not be covered during radiologic procedures.

Arm

Intervention/Treatment

Experimental: Uncovered

Dexcom G6 CGM will be uncovered during standard of care radiologic procedures.

Other: Uncovered CGM during radiologic procedures

Dexcom G6 CGM will not be covered during radiologic procedures.

Outcome Measures

Primary Outcome Measures

Dexcom G6 accuracy post radiation exposure [3 months]
Dexcom G6 transmitter readings will be compared to glucometer readings until the transmitter is changed.
Post radiation Dexcom G6 transmitter functional duration [3 months]
Data will be collected on participant procedures resulting in radiation exposure and transmitter change date.

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

Deborah Elder
DexCom, Inc.

Investigators

Principal Investigator: Deb Elder, MD, Children's Hospital Medical Center, Cincinnati

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Deborah Elder, ASSOCIATE PROFESSOR, Children's Hospital Medical Center, Cincinnati

ClinicalTrials.gov Identifier:

NCT05607576

Other Study ID Numbers:

2021-0838

First Posted:

Nov 7, 2022

Last Update Posted:

Nov 7, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Deborah Elder, ASSOCIATE PROFESSOR, Children's Hospital Medical Center, Cincinnati

Dexcom G6

Study Results

No Results Posted as of Nov 7, 2022