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Evaluate safety of non-adjunctive CGM use in CGM naive participants.
The study comprises recruitment and consenting of pediatric and adult participants. At entry, the following information will be collected: demographics, labs, clinical and diabetes history information (history of mild/severe hypoglycemia or DKA events in the past 6 months and SMBG testing frequency). There are 3 clinic visits: Study Entry, Month 6 and Month 12 . Monthly phone contacts will be made to assess for any mild/severe hypoglycemic or DKA events and any details surrounding an event. Clinic visits at Months 6 and 12 will capture frequency of SMBG testing, A1C level and PRO information. CGM data will be obtained during the study to assess for CGM adherence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM/BGM Group | single-group, whereby participant is their own control. Use of a Blood Glucose Meter (BGM) for 6 months is compared to use of the G5 and G6 CGM System for 6 months, with collection of major diabetes related events (mild/severe hypoglycemia and DKA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitoring (CGM) | Device | Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hypoglycemic events | Change in average number of hypoglycemic events per patient between CGM use compared to BGM use | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in A1C | Percent change in A1C lab between CGM use period compared to BGM use period. | 6 months |
| Change in incidence of hypoglycemic events | Percent change of participants with at least one event between CGM use period compared to BGM use period. |
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Inclusion Criteria:
Exclusion Criteria:
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Adults and pediatrics (2 or older), naïve to CGM, with Type 1 or insulin-requiring Type 2 diabetes
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stayce Beck, PhD, MPH | Contact | 8582036454 | stayce.beck@dexcom.com | |
| Nelly Njeru | Contact | 8582036379 | nelly.njeru@dexcom.com |
| Name | Affiliation | Role |
|---|---|---|
| David Price, MD | Dexcom-Medical Affairs | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Whittier Diabetes Institute | Completed | La Jolla | California | 92037 | United States | |
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| 6 months |
| Change in GMSS PRO scores | Percent change in mean scores for the Glucose monitoring satisfaction survey (GMSS) [Emotional and Trust subscales] between CGM use period compared to BGM use period. | 6 months |
| Change in Diabetes Distress Scale (DDS) PRO scores | Percent change in mean scores for the DDS between CGM use period compared to BGM use period. | 6 months |
| Change in Hypoglycemia Fear PRO scores | Percent change in mean scores for the Hypoglycemia Fear Survey between CGM use period compared to BGM use period. | 6 months |
| Change in Hypoglycemia Confidence PRO scores | Percent change in mean scores for the Hypoglycemia Confidence Scale between CGM use period compared to BGM use period. | 6 months |
| Diabetes and Endocrine Associates |
| Completed |
| La Mesa |
| California |
| 91942 |
| United States |
| Centre of Excellence in Diabetes and Endocrinology | Recruiting | Sacramento | California | 95821 | United States |
|
| Mills-Peninsula Medical Center | Completed | San Mateo | California | 94401 | United States |
| Sansum Diabetes Research Institute | Completed | Santa Barbara | California | 93105 | United States |
| University of Florida Pediatric Endocrinology | Active, not recruiting | Gainesville | Florida | 32608 | United States |
| Intervent Clinical Research Center | Recruiting | Pembroke Pines | Florida | 33024 | United States |
|
| University of South Florida Clinical Research Center | Recruiting | Tampa | Florida | 33612 | United States |
|
| Atlanta Diabetes | Completed | Atlanta | Georgia | 30318 | United States |
| Rocky Mountain Diabetes Center | Completed | Idaho Falls | Idaho | 83404 | United States |
| Northshore University Health System | Completed | Skokie | Illinois | 60077 | United States |
| Iowa Diabetes & Endocrinology Research Center | Completed | Des Moines | Iowa | 50314 | United States |
| Cotton O'Neil Clinical Research | Recruiting | Topeka | Kansas | 66606 | United States |
|
| International Diabetes Research Center | Completed | Minneapolis | Minnesota | 55416 | United States |
| Children's Mercy Hospital | Recruiting | Kansas City | Missouri | 64108 | United States |
|
| Methodist Physicians Clinic - Diabetes and Endocrine Specialists | Completed | Omaha | Nebraska | 68114 | United States |
| Mountain Diabetes and Endocrine Center | Completed | Asheville | North Carolina | 28803 | United States |
| Carteret Medical Group | Completed | Morehead City | North Carolina | 28557 | United States |
| Diabetes & Endocrinology Consultants, PC | Completed | Morehead City | North Carolina | 28557 | United States |
| University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
|
| Vanderbilt Eskind Diabetes Clinic | Completed | Nashville | Tennessee | 37212 | United States |
| Amarillo Medical Specialists, LLP | Recruiting | Amarillo | Texas | 79106 | United States |
|
| Texas Diabetes and Endocrine | Completed | Austin | Texas | 78731 | United States |
| Research Institute of Dallas | Completed | Dallas | Texas | 75231 | United States |
| Advanced Research Associates | Recruiting | Ogden | Utah | 84405 | United States |
|
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |
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