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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM Arm | Other | Children with type 2 diabetes will wear a continuous glucose monitor for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitor | Device | Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 days, 10 days |
| Hemoglobin A1c | HbA1c at baseline and 3-6 month follow-up. | Baseline, 3 - 6 months |
| More Frequent Insulin Administration | Response to "Did you take your insulin more often than before?" | 10 days from CGM placement |
| More Frequent Glycemic Control Monitoring | Response to "Do you look at or check your blood sugar more often than before?" | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Risa M Wolf, MD | Johns Hopkins School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Pediatric Diabetes Center | Baltimore | Maryland | 21287 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40303266 | Derived | Phu A, Lin T, Manfredo JA, Brown EA, Wolf RM. Similar Perceptions on Continuous Glucose Monitor Use amongst Youth with Type 1 and Type 2 Diabetes. Pediatr Diabetes. 2023 Jun 19;2023:1979635. doi: 10.1155/2023/1979635. eCollection 2023. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CGM Sample Given | Youth with T2D > 3 months, on insulin, with no prior CGM use were enrolled |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | 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 | Participants with CGM use at both 5-days and 10-days | Posted | Mean | Standard Deviation | percentage of time in target range | 5 days, 10 days |
|
|
6 months
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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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DKA admission | Endocrine disorders | Non-systematic Assessment |
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The limitations of this study include the small study size with a limited number of participants completing both 10-day trial period and 3/6-month follow up visits. There were a large number of patients who had device connectivity and adhesive issues. Many participants were lost to follow up.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Risa Wolf | Johns Hopkins Medicine | 410-955-6463 | rwolf@jhu.edu |
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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 12, 2023 | Jul 12, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| years |
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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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| Region of Enrollment | Number | participants |
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| HbA1c | Median | Inter-Quartile Range | Percentage of glycosylated hemoglobin |
|
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| Primary | Hemoglobin A1c | HbA1c at baseline and 3-6 month follow-up. | Participants with A1c available at baseline and 3-6 months | Posted | Mean | Standard Deviation | percentage of glycosylated hemoglobin A1 | Baseline, 3 - 6 months |
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| Primary | More Frequent Insulin Administration | Response to "Did you take your insulin more often than before?" | Participants with 10 day follow up surveys | Posted | Count of Participants | Participants | 10 days from CGM placement |
|
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| Primary | More Frequent Glycemic Control Monitoring | Response to "Do you look at or check your blood sugar more often than before?" | Participants who responded to the survey conducted at 10 day follow up. | Posted | Count of Participants | Participants | 10 days |
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| 0 |
| 41 |
| 2 |
| 41 |
| 0 |
| 41 |
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| D004700 | Endocrine System Diseases |
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| Measurements |
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| Measurements |
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