Trial Outcomes & Findings for Dexcom G6 for Total Pancreatectomy With Islet Autotransplantation (TPIAT) Patients (NCT NCT05607576)

Last Updated: 2025-05-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

18 participants

Primary outcome timeframe

3 months

Results posted on

2025-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	18
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study immediate sensor error	2
Overall Study Physician Decision	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Uncovered n=14 Participants 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.
Age, Categorical <=18 years	14 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
BMI percentile	79.4 Percentile n=5 Participants
Insurance Private	8 Participants n=5 Participants
Insurance Medicaid	5 Participants n=5 Participants
Insurance Private and Medicaid	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	CGM Uncovered -Pre Radiation Exposures n=1435 Matched blood glucose readings Uncovered CGM during radiologic procedures: Dexcom G6 CGM will not be covered during radiologic procedures, This data grouping provides baseline data.	CGM Uncovered - Post Radiation Exposure n=1832 Matched blood glucose readings blood glucose readings after transmitter was exposed to scatter radiation.	CGM Uncovered - Post Radiation Exposure >500 µGy n=901 Matched blood glucose readings blood glucose readings after transmitter was exposed to scatter radiation greater than 500 µGy	Handheld Clinical Glucometer n=2793 Matched blood glucose readings ACCU-CHEK handheld glucometer used in clinical setting	Handheld Home Glucometer. n=1375 Matched blood glucose readings Contour glucometer used at home.
Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) error grid section A	806 Matched blood glucose readings	1226 Matched blood glucose readings	704 Matched blood glucose readings	1715 Matched blood glucose readings	1020 Matched blood glucose readings
Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) error grid section B	606 Matched blood glucose readings	570 Matched blood glucose readings	187 Matched blood glucose readings	1033 Matched blood glucose readings	329 Matched blood glucose readings
Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) error grid section C	6 Matched blood glucose readings	7 Matched blood glucose readings	5 Matched blood glucose readings	56 Matched blood glucose readings	69 Matched blood glucose readings
Dexcom G6 Accuracy Post Radiation Exposure by Clark Error Analysis (Zone A and B %) error grid section D	17 Matched blood glucose readings	31 Matched blood glucose readings	5 Matched blood glucose readings	47 Matched blood glucose readings	15 Matched blood glucose readings

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	CGM Uncovered -Pre Radiation Exposures n=3294 Matched blood glucose readings Uncovered CGM during radiologic procedures: Dexcom G6 CGM will not be covered during radiologic procedures, This data grouping provides baseline data.	CGM Uncovered - Post Radiation Exposure n=586 Matched blood glucose readings blood glucose readings after transmitter was exposed to scatter radiation.	CGM Uncovered - Post Radiation Exposure >500 µGy n=288 Matched blood glucose readings blood glucose readings after transmitter was exposed to scatter radiation greater than 500 µGy	Handheld Clinical Glucometer ACCU-CHEK handheld glucometer used in clinical setting	Handheld Home Glucometer. Contour glucometer used at home.
Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) error grid Zone A	2065 Matched blood glucose readings	446 Matched blood glucose readings	226 Matched blood glucose readings	—	—
Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) error grid Zone B	1173 Matched blood glucose readings	128 Matched blood glucose readings	61 Matched blood glucose readings	—	—
Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) error grid Zone C	16 Matched blood glucose readings	2 Matched blood glucose readings	0 Matched blood glucose readings	—	—
Post Radiation Dexcom G6 Transmitter Functional Duration by Clark Error Analysis (Zone A and B %) error grid Zone D	43 Matched blood glucose readings	10 Matched blood glucose readings	1 Matched blood glucose readings	—	—

Adverse Events

Uncovered

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Deborah Elder; Associate Professor

Cincinnati Children's Hospital Medical Center

Phone: 5136364744

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place