Hyperglycemia Due to Type 2 Diabetes Mellitus, Type 2 Diabetes
Conditions
Keywords
continuous glucose monitoring (CGM), 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 pediatric Type 2 diabetes patients improves short term time in range glucose control and 3-6 month glycemic control.
Detailed description
The purpose of this prospective study is to determine if trial use of a Dexcom G6 CGM system for 10 days has an impact on short and long term glycemic control and behavior in youth onset Type 2 diabetes.
Interventions
DEVICEContinuous glucose monitor
Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
Sponsors
Johns Hopkins University
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
* Type 2 diabetes, diabetes duration \>3 months
Exclusion criteria
* Prior use of CGM
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time in Range Glucose Control | 5 days, 10 days | The percentage of total time that the patient uses the continuous glucose monitor (CGM) where the blood glucose falls between 70 and 180 mg/dL |
| Hemoglobin A1c | Baseline, 3 - 6 months | HbA1c at baseline and 3-6 month follow-up. |
| More Frequent Insulin Administration | 10 days from CGM placement | Response to Did you take your insulin more often than before? |
| More Frequent Glycemic Control Monitoring | 10 days | Response to Do you look at or check your blood sugar more often than before? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CGM Arm Children with type 2 diabetes will wear a continuous glucose monitor for 10 days.
Continuous glucose monitor: Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device did not connect | 1 |
| Overall Study | Lost to Follow-up | 4 |
Baseline characteristics
| Characteristic | CGM Arm |
|---|---|
| Age, Continuous | 16.2 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| HbA1c | 10.3 Percentage of glycosylated hemoglobin |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 34 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 | 3 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 41 |
| other Total, other adverse events | 0 / 41 |
| serious Total, serious adverse events | 2 / 41 |
Outcome results
Primary
Hemoglobin A1c
HbA1c at baseline and 3-6 month follow-up.
Time frame: Baseline, 3 - 6 months
Population: Participants with A1c available at baseline and 3-6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM Sample Given | Hemoglobin A1c | Baseline | 10.2 percentage of glycosylated hemoglobin A1 | Standard Deviation 2.8 |
| CGM Sample Given | Hemoglobin A1c | 3-6 months | 10.3 percentage of glycosylated hemoglobin A1 | Standard Deviation 3.2 |
Primary
More Frequent Glycemic Control Monitoring
Response to Do you look at or check your blood sugar more often than before?
Time frame: 10 days
Population: Participants who responded to the survey conducted at 10 day follow up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CGM Sample Given | More Frequent Glycemic Control Monitoring | Yes | 23 Participants |
| CGM Sample Given | More Frequent Glycemic Control Monitoring | No | 0 Participants |
| CGM Sample Given | More Frequent Glycemic Control Monitoring | Sometimes | 1 Participants |
Primary
More Frequent Insulin Administration
Response to Did you take your insulin more often than before?
Time frame: 10 days from CGM placement
Population: Participants with 10 day follow up surveys
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CGM Sample Given | More Frequent Insulin Administration | Yes | 14 Participants |
| CGM Sample Given | More Frequent Insulin Administration | No | 8 Participants |
| CGM Sample Given | More Frequent Insulin Administration | Sometimes | 2 Participants |
Primary
Percentage of Time in Range Glucose Control
The percentage of total time that the patient uses the continuous glucose monitor (CGM) where the blood glucose falls between 70 and 180 mg/dL
Time frame: 5 days, 10 days
Population: Participants with CGM use at both 5-days and 10-days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CGM Sample Given | Percentage of Time in Range Glucose Control | 5 days | 49.2 percentage of time in target range | Standard Deviation 38 |
| CGM Sample Given | Percentage of Time in Range Glucose Control | 10 days | 50.7 percentage of time in target range | Standard Deviation 39 |