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

NCT ID: NCT05607576

Last Updated: 2025-05-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2024-05-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

This study is not blinded

Study Groups

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Uncovered

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

Group Type EXPERIMENTAL

Uncovered CGM during radiologic procedures

Intervention Type OTHER

Dexcom G6 CGM will not be covered during radiologic procedures.

Interventions

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Uncovered CGM during radiologic procedures

Dexcom G6 CGM will not be covered during radiologic procedures.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DexCom, Inc.

INDUSTRY

Sponsor Role collaborator

Deborah Elder

OTHER

Sponsor Role lead

Responsible Party

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Deborah Elder

ASSOCIATE PROFESSOR

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Deb Elder, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

References

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Tellez S, Hornung L, Smith E, Trout A, Brady S, Lowe C, Courter J, Abu-El-Haija M, Elder D. Real-World Accuracy of a Continuous Glucose Monitoring System after Radiologic Exposure. Pediatr Diabetes. 2024 Aug 7;2024:2210509. doi: 10.1155/2024/2210509. eCollection 2024.

Reference Type RESULT
PMID: 40302953 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2021-0838

Identifier Type: -

Identifier Source: org_study_id

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