Diabetes
Conditions
Keywords
Dexcom G6
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.
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.
Interventions
OTHERUncovered CGM during radiologic procedures
Dexcom G6 CGM will not be covered during radiologic procedures.
Sponsors
DexCom, Inc.
Deborah Elder
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
This study is not blinded
Eligibility
Sex/Gender
ALL
Age
11 Years to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | 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 %) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | immediate sensor error | 2 |
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Uncovered |
|---|---|
| Age, Categorical <=18 years | 14 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| BMI percentile | 79.4 Percentile |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Insurance Medicaid | 5 Participants |
| Insurance Private | 8 Participants |
| Insurance Private and Medicaid | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 14 |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CGM Uncovered -Pre Radiation Exposures | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section A | 806 Matched blood glucose readings |
| CGM Uncovered -Pre Radiation Exposures | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section B | 606 Matched blood glucose readings |
| CGM Uncovered -Pre Radiation Exposures | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section C | 6 Matched blood glucose readings |
| CGM Uncovered -Pre Radiation Exposures | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section D | 17 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section A | 1226 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section D | 31 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section B | 570 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section C | 7 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure >500 µGy | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section D | 5 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure >500 µGy | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section B | 187 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure >500 µGy | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section C | 5 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure >500 µGy | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section A | 704 Matched blood glucose readings |
| Handheld Clinical Glucometer | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section A | 1715 Matched blood glucose readings |
| Handheld Clinical Glucometer | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section B | 1033 Matched blood glucose readings |
| Handheld Clinical Glucometer | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section D | 47 Matched blood glucose readings |
| Handheld Clinical Glucometer | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section C | 56 Matched blood glucose readings |
| Handheld Home Glucometer. | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section D | 15 Matched blood glucose readings |
| Handheld Home Glucometer. | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section C | 69 Matched blood glucose readings |
| Handheld Home Glucometer. | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section B | 329 Matched blood glucose readings |
| Handheld Home Glucometer. | Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) | error grid section A | 1020 Matched blood glucose readings |
p-value: <0.05Mixed Models Analysis
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.
Time frame: 3 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| CGM Uncovered -Pre Radiation Exposures | Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) | error grid Zone A | 2065 Matched blood glucose readings |
| CGM Uncovered -Pre Radiation Exposures | Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) | error grid Zone B | 1173 Matched blood glucose readings |
| CGM Uncovered -Pre Radiation Exposures | Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) | error grid Zone C | 16 Matched blood glucose readings |
| CGM Uncovered -Pre Radiation Exposures | Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) | error grid Zone D | 43 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure | Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) | error grid Zone D | 10 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure | Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) | error grid Zone A | 446 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure | Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) | error grid Zone C | 2 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure | Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) | error grid Zone B | 128 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure >500 µGy | Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) | error grid Zone D | 1 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure >500 µGy | Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) | error grid Zone B | 61 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure >500 µGy | Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) | error grid Zone C | 0 Matched blood glucose readings |
| CGM Uncovered - Post Radiation Exposure >500 µGy | Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) | error grid Zone A | 226 Matched blood glucose readings |
p-value: <0.05Mixed Models Analysis