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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
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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 high risk, poorly controlled pediatric Type 1 diabetes patients increases uptake of personal CGM use, and improves short-term time in range glucose control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexcom G6 Continuous Glucose Monitor | Experimental | Children with type 1 diabetes will wear a continuous glucose monitor (CGM) for 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G6 Continuous Glucose Monitor | Device | Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Personal CGM Use | Evaluate whether there is any change in uptake of personal CGM after 10-day trial. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1-5 days and 6-10 days |
| Change in Hemoglobin A1c | Changes in HbA1c from baseline to next available A1c at 3-6 month follow up visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Risa Wolf, MD | Johns Hopkins University | 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. | |
| 36223197 | Derived | Lin T, Manfredo JA, Illesca N, Abiola K, Hwang N, Salsberg S, Akhtar Y, Mathioudakis N, Brown EA, Wolf RM. Improving Continuous Glucose Monitoring Uptake in Underserved Youth with Type 1 Diabetes: The IMPACT Study. Diabetes Technol Ther. 2023 Jan;25(1):13-19. doi: 10.1089/dia.2022.0347. Epub 2022 Nov 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Personal CGM Use | Evaluate whether there is any change in uptake of personal CGM after 10-day trial. | Posted | Count of Participants | Participants | Baseline and 3 months |
|
|
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 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DKA admission | Endocrine disorders | Non-systematic Assessment | Admission for diabetic ketoacidosis |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Otalgia of both ears | Ear and labyrinth disorders | Non-systematic Assessment | Otalgia of both ears, seen in ER, middle ear effusions. |
The patient cohort was small, and may not be generalizable to all patients with T1D. Further, the mean HbA1c of individuals in the study was well above ADA target, and the impact of trial CGM on patients with HbA1c closer to goal ADA range may be different. Additionally, follow-up CGM data was not available for most patients, thus limiting data for analysis.
| 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 | Jun 5, 2023 | Jul 16, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Baseline, 3-6 months |
| Using Personal CGM | Percentage of participants using CGM at time of follow up, of those who reported wanting a personal CGM | 3-6 months |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Insurance | Type of insurance participant was using at time of enrollment, collected from the medical record. | Count of Participants | Participants |
|
| HbA1c | Mean | Standard Deviation | Percentage |
|
|
| 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 | Only 15/26 participants had data from both periods | Posted | Mean | Standard Deviation | Percentage of time in range | 1-5 days and 6-10 days |
|
|
|
| Secondary | Change in Hemoglobin A1c | Changes in HbA1c from baseline to next available A1c at 3-6 month follow up visit | 20/26 participants had a follow up A1c lab available. | Posted | Mean | Standard Deviation | Percentage | Baseline, 3-6 months |
|
|
|
| Secondary | Using Personal CGM | Percentage of participants using CGM at time of follow up, of those who reported wanting a personal CGM | 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.) | Posted | Count of Participants | Participants | 3-6 months |
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|
|
| 0 |
| 26 |
| 5 |
| 26 |
| 1 |
| 26 |
|
| ER Visit, renal stone | Renal and urinary disorders | Non-systematic Assessment | Kidney Stone |
|
| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment | Hospitalization due to severe abdominal pain. |
|
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |