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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uncovered | Experimental | Dexcom G6 CGM will be uncovered during standard of care radiologic procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uncovered CGM during radiologic procedures | Other | Dexcom G6 CGM will not be covered during radiologic procedures. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
• Hemo- or peritoneal dialysis
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| Name | Affiliation | Role |
|---|---|---|
| Deb Elder, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40302953 | Result | 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. |
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We do not plan to share any individual Participant data. We will be publishing aggregate data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Uncovered | Dexcom G6 CGM will be uncovered during standard of care radiologic procedures. Uncovered CGM during radiologic procedures: Dexcom G6 CGM will not be covered during radiologic procedures. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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14 participants were enrolled and completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Uncovered | Dexcom G6 CGM will be uncovered during standard of care radiologic procedures. Uncovered CGM during radiologic procedures: Dexcom G6 CGM will not be covered during radiologic procedures. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Count of Units | Matched blood glucose readings | 3 months | Matched blood glucose readings | Matched blood glucose readings |
|
Bassline to end of transmitter use (~3 months)
Standard AE definitions were used in this study. There was no more than minimal risk for participants because they are using both the test device and the standard of care glucometer. Any elevated or low blood sugars levels would be caught by the monitoring system in place and would be acted on for clinical care.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Uncovered | Dexcom G6 CGM will be uncovered during standard of care radiologic procedures. Uncovered CGM during radiologic procedures: Dexcom G6 CGM will not be covered during radiologic procedures. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deborah Elder; Associate Professor | Cincinnati Children's Hospital Medical Center | 5136364744 | Deborah.Elder@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2022 | Mar 20, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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This study is not blinded
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI percentile | Mean | Inter-Quartile Range | Percentile |
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| Insurance | Count of Participants | Participants |
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| CGM Uncovered -Pre Radiation Exposures |
Uncovered CGM during radiologic procedures: Dexcom G6 CGM will not be covered during radiologic procedures, This data grouping provides baseline data. |
| OG001 | CGM Uncovered - Post Radiation Exposure | blood glucose readings after transmitter was exposed to scatter radiation. |
| OG002 | CGM Uncovered - Post Radiation Exposure >500 µGy | blood glucose readings after transmitter was exposed to scatter radiation greater than 500 µGy |
| OG003 | Handheld Clinical Glucometer | ACCU-CHEK handheld glucometer used in clinical setting |
| OG004 | Handheld Home Glucometer. | Contour glucometer used at home. |
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| Primary | 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. | 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. | Posted | Count of Units | Matched blood glucose readings | 3 months | Matched blood glucose readings | Matched blood glucose readings |
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| 0 |
| 14 |
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| 14 |
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| error grid Zone C |
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| error grid Zone D |
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