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OpenTrials
Completed

NCT Number: NCT05607576

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

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

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

11 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Uncovered CGM during radiologic procedures

Other

Dexcom G6 CGM will not be covered during radiologic procedures.

Primary outcomes

  1. Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %)

    Time frame: 3 months

    Blood Glucose levels (mg/dL) obtained by the Dexcom G6 sensor and transmitter compared to blood glucose levels (mg/dL) obtained by a handheld glucometer until the transmitter is changed. The Clarke Error Grid Analysis method was used to compare absolute values. Accuracy reported as percentage of comparators in Zone A and B.

  2. Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %)

    Time frame: 3 months

    Transmitter functional duration is determined by time from TPIAT procedure and CGM placement (baseline) to time for Transmitter changed (approximately 3 months), Functionality is determined by analysis of Blood Glucose (mg/dL) in month groupings (0-1month, 1-2months, 2+ months from baseline. Blood Glucose levels (mg/dL) obtained by the Dexcom G6 sensor and transmitter compared to blood glucose levels (mg/dL) obtained by a handheld glucometer until the transmitter is changed. The Clarke Error Grid Analysis method was used to compare absolute values. Accuracy reported as percentage of comparators in Zone A and B.

Sponsors and collaborators

Lead sponsor

Deborah Elder

Other

Collaborators

  • DexCom, Inc.

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 7, 2022
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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