DiabetesNCT05607576

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

A study testing Uncovered CGM during radiologic procedures in people with Diabetes, run by Deborah Elder at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 11 to 25 years
Conditions the study is for: Diabetes
What is being tested?: Uncovered CGM during radiologic procedures
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 1 Mar 2022to 1 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 11 to 25 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Who cannot join

Hemo- or peritoneal dialysis

Trial locations and contacts

1 site in 1 country.

United States1 site

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Diabetes
Being tested: Uncovered CGM during radiologic procedures
Keywords: Dexcom G6
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Uncovered CGM during radiologic proceduresOther
Dexcom G6 CGM will not be covered during radiologic procedures.

Study groups in NCT05607576
Study group	Role	What they receive
Uncovered	Experimental	Dexcom G6 CGM will be uncovered during standard of care radiologic procedures. Receives: Other: Uncovered CGM during radiologic procedures

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20221 May 2024

First posted7 Nov 2022
Study start1 Mar 2022
Primary completion20 Oct 2023
Study completion1 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05607576
Sponsor's protocol ID: 2021-0838
Status last verified: May 2025
First submitted: 19 Jul 2022
Last updated: 6 May 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: We do not plan to share any individual Participant data. We will be publishing aggregate data.

Publications

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.
PubMed 40302953

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Accuracy of Dexcom G6 After Radiation Exposure-A Cross Sectional and Longitudinal Analysis
ClinicalTrials.gov ID: NCT05607576
Acronym / sponsor ID: 2021-0838
Conditions: Diabetes
Keywords: Dexcom G6
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: Deborah ElderUniversity, hospital or other
Collaborators: DexCom, Inc.
Study start: 1 Mar 2022 (actual)
Primary completion: 20 Oct 2023 (actual)
Study completion: 1 May 2024 (actual)
First posted: 7 Nov 2022 (actual)
Results: Posted 6 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Uncovered	Experimental	Other: Uncovered CGM during radiologic proceduresDexcom G6 CGM will be uncovered during standard of care radiologic procedures.

Who may qualify

Ages: 11 to 25 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Hemo- or peritoneal dialysis

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Uncovered CGM during radiologic proceduresDexcom G6 CGM will not be covered during radiologic procedures.	Other	Uncovered

Primary outcome

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.
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.

Results and safety

Results posted to the registry on 6 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Uncovered	18	14

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

Time frame: 3 months. Count of units. Unit: Matched blood glucose readings

Measure	CGM Uncovered -Pre Radiation Exposures n = 14	CGM Uncovered - Post Radiation Exposure n = 14	CGM Uncovered - Post Radiation Exposure >500 µGy n = 14	Handheld Clinical Glucometer n = 14	Handheld Home Glucometer. n = 14
error grid section A	806	1226	704	1715	1020
error grid section B	606	570	187	1033	329
error grid section C	6	7	5	56	69
error grid section D	17	31	5	47	15

CGM Uncovered -Pre Radiation Exposures vs CGM Uncovered - Post Radiation Exposure vs CGM Uncovered - Post Radiation Exposure >500 µGy vs Handheld Clinical Glucometer vs Handheld Home Glucometer.: p <0.05, Mixed Models Analysis

Population analysed: 4168 CGM-glucometer matched data points analyzed, 67% of which were collected from the HG (ACCU-CHEK®). A total of 1375 matched data points were collected from the participants in the outpatient setting using the SIG (Contour®). There were 1435 matched pairs before radiation exposure and 2,733 matched data points after radiation exposure. Absolute blood glucose readings were plotted and analyzed using the Clarke Error Grid Analysis. Data points are matched blood glucose readings.

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

Time frame: 3 months. Count of units. Unit: Matched blood glucose readings

Measure	Uncovered - 0-1 Month Post TPIAT n = 14	Uncovered - 1-2 Months Post TPIAT n = 14	Uncovered - 2+ Months Post TPIAT n = 14
error grid Zone A	2065	446	226
error grid Zone B	1173	128	61
error grid Zone C	16	2	0
error grid Zone D	43	10	1

Uncovered - 0-1 Month Post TPIAT: p <0.05, Mixed Models Analysis

Population analysed: Data collected on functionality of transmitter over time (blood glucose (BG) mg/dL/months from TPIAT). Data points analyzed using the Clarke Error Grid analysis of matched blood glucose readings.

Adverse events

Time frame: Bassline to end of transmitter use (~3 months). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Uncovered	0 of 14 (0%)	0 of 14 (0%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 40302953Tellez 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.
Individual participant dataSharing planned: No. We do not plan to share any individual Participant data. We will be publishing aggregate data.

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Type 2 Diabetes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Deb Elder, MD principal investigator

Children's Hospital Medical Center, Cincinnati

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Uncovered CGM during radiologic procedures in people with Diabetes, run by Deborah Elder at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05607576, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.