High Blood Sugar, Hypoglycemia, Type 1 Diabetes
Conditions
Keywords
Continuous Glucose Monitoring, Time in range, Hemoglobin A1c
Brief summary
The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for a 10 day wear period in high risk, poorly controlled pediatric Type 1 diabetes patients increases uptake of personal CGM use, and improves short-term time in range glucose control.
Interventions
Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Sponsors
Johns Hopkins University
DexCom, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Type 1 diabetes for \>3 months
Exclusion criteria
* CGM use in the last 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Personal CGM Use | Baseline and 3 months | Evaluate whether there is any change in uptake of personal CGM after 10-day trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Percent Time in Range Glucose Control | 1-5 days and 6-10 days | Changes in time in range glucose control from 1-5 days to 6-10 days from the Dexcom CGM |
| Change in Hemoglobin A1c | Baseline, 3-6 months | Changes in HbA1c from baseline to next available A1c at 3-6 month follow up visit |
| Using Personal CGM | 3-6 months | Percentage of participants using CGM at time of follow up, of those who reported wanting a personal CGM |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexcom G6 Continuous Glucose Monitor Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days.
Dexcom G6 Continuous Glucose Monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days. | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Dexcom G6 Continuous Glucose Monitor |
|---|---|
| Age, Continuous | 14.1 years STANDARD_DEVIATION 2.9 |
| HbA1c | 10.7 Percentage STANDARD_DEVIATION 2.4 |
| Insurance Private Insurance | 9 Participants |
| Insurance Public Insurance | 17 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Multi-racial (American Indian / White) | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic Black | 11 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Non-Hispanic White | 11 Participants |
| Region of Enrollment United States | 26 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 1 / 26 |
| serious Total, serious adverse events | 5 / 26 |
Outcome results
Primary
Change in Personal CGM Use
Evaluate whether there is any change in uptake of personal CGM after 10-day trial.
Time frame: Baseline and 3 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexcom G6 Continuous Glucose Monitor | Change in Personal CGM Use | Wants a personal CGM | 22 Participants |
| Dexcom G6 Continuous Glucose Monitor | Change in Personal CGM Use | Does not want a personal CGM | 4 Participants |
Secondary
Change in Hemoglobin A1c
Changes in HbA1c from baseline to next available A1c at 3-6 month follow up visit
Time frame: Baseline, 3-6 months
Population: 20/26 participants had a follow up A1c lab available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 Continuous Glucose Monitor | Change in Hemoglobin A1c | Baseline | 10.9 Percentage | Standard Deviation 2.6 |
| Dexcom G6 Continuous Glucose Monitor | Change in Hemoglobin A1c | 3-6 month follow up | 10.8 Percentage | Standard Deviation 2.6 |
Secondary
Change in the Percent Time in Range Glucose Control
Changes in time in range glucose control from 1-5 days to 6-10 days from the Dexcom CGM
Time frame: 1-5 days and 6-10 days
Population: Only 15/26 participants had data from both periods
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexcom G6 Continuous Glucose Monitor | Change in the Percent Time in Range Glucose Control | 1-5 days | 41.9 Percentage of time in range | Standard Deviation 21.2 |
| Dexcom G6 Continuous Glucose Monitor | Change in the Percent Time in Range Glucose Control | 6-10 days | 32.8 Percentage of time in range | Standard Deviation 15.2 |
Secondary
Using Personal CGM
Percentage of participants using CGM at time of follow up, of those who reported wanting a personal CGM
Time frame: 3-6 months
Population: 21/26 participants wanted a personal CGM AND completed 3-6 month follow-up. (Of the total participants 4 participants did not want CGM. 1 participant had no 3-6 month follow up. Thus, this analysis includes the remaining 21 participants.)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexcom G6 Continuous Glucose Monitor | Using Personal CGM | 9 Participants |