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

NCT05607576 | Completed Results

• 1 other identifier: 2021-0838
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Dexcom G6

Outcome Measures

Primary Outcomes (2)

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

  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.

  3 months

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

  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.

  3 months

Study Arms (1)

Uncovered

EXPERIMENTAL

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

Other: Uncovered CGM during radiologic procedures

Interventions

Uncovered CGM during radiologic procedures OTHER

Dexcom G6 CGM will not be covered during radiologic procedures.

Uncovered

Eligibility Criteria

• Age: 11 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Planned TPIAT at CCHMC
• Staying in-patient at CCHMC post TPIAT
• Planned to receive a Dexcom G6 CGM

You may not qualify if:

• Hemo- or peritoneal dialysis

Sponsors & Collaborators

• Deborah Elder: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 40302953 RESULT

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Deborah Elder; Associate Professor
• Organization: Cincinnati Children's Hospital Medical Center

Deborah.Elder@cchmc.org

5136364744

Study Officials

• Deb Elder, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study is not blinded
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Study Record Dates

• First Submitted: July 19, 2022
• First Posted: November 7, 2022
• Study Start: March 1, 2022
• Primary Completion: October 20, 2023
• Study Completion: May 1, 2024
• Last Updated: May 6, 2025
• Results First Posted: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)