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| Name | Class |
|---|---|
| Breakthrough T1D | OTHER |
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This study aims at quantifying the accuracy of a self-administered fingerstick based glucose tolerance test (GTT@Home) respect to the gold-standard in-clinic venous plasma measures during the oral glucose tolerance test (OGTT) across a wide range of glycemic values in people at risk for clinical type 1 diabetes (T1D) (carriers of at least one islet autoantibody) or with new onset Stage 3 T1D within 100 days from the diagnosis.
Investigators will conduct an observational longitudinal study that will include one home-based unsupervised GTT@Home test, a standard OGTT at a research facility and a supervised GTT@Home. Additionally, participants will have up to10-day blinded-CGM data collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single islet autoantibody | Participants with single islet autoantibody |
| |
| 2 or more positive islet antibodies | Participants with 2 or more positive islet antibodies who are in (Stage 1) or (Stage 2) without dysglycemia |
| |
| Recently diagnosed with diabetes | Participants meeting the diagnostic criteria for diabetes (stage 3 T1D) within 100 days from the diagnosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GTT@Home | Diagnostic Test | self-administered fingerstick based glucose tolerance test |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of GTT@Home | The accuracy will be quantified by correlation between GTT@Home and OGTT glucose measures as well as by the mean absolute relative difference between the two measures. | up to 4 weeks from enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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A total of 60 participants will be enrolled at the Yale University Pediatric and Adult Diabetes Clinic (New Haven, CT). To ensure there is wide variation in glucose ranges with glucose tolerance testing a total of 3 cohorts will be recruited.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcia DeSousa, BA | Contact | 203-737-4805 | marcia.desousa@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Sherr, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University Pediatric and Adult Diabetes Clinic | Recruiting | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |