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| Name | Class |
|---|---|
| Mittal Global Clinical Trial Services | UNKNOWN |
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Current gold standard methodologies for diagnosing type 2 diabetes (T2D) or prediabetes can be unreliable and inaccurate, and require the need for multiple different tests for comparison. It is possible that a simpler and more refined method of diagnosing T2D or prediabetes involves examining the proportional-integral (PI) control system of the body's glycemic function (i.e., a model of the glucose curve). The purpose of this research is to examine how well a PI model can diagnose nondiabetic, prediabetic, or diabetic patients based on glucose data gathered from a wearable glucose monitoring device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low to Moderate Risk | The CANRISK Canadian Diabetes Risk Questionnaire will be used for study group categorization to assess who is at risk of having prediabetes or type 2 diabetes. Participants will be categorized into one the following groups: i) low to moderate risk; ii) high risk, iii) very high risk. |
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| High Risk | The CANRISK Canadian Diabetes Risk Questionnaire will be used for study group categorization to assess who is at risk of having prediabetes or type 2 diabetes. Participants will be categorized into one the following groups: i) low to moderate risk; ii) high risk, iii) very high risk. |
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| Very High Risk | The CANRISK Canadian Diabetes Risk Questionnaire will be used for study group categorization to assess who is at risk of having prediabetes or type 2 diabetes. Participants will be categorized into one the following groups: i) low to moderate risk; ii) high risk, iii) very high risk. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abbott Freestyle Libre Pro | Device | Continuous glucose monitoring device to analyze diabetes biomarkers. |
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| Measure | Description | Time Frame |
|---|---|---|
| Glucose biomarker data from the continuous glucose monitoring device, which will be analyzed as a function of different homeostasis responses from the 3 different cohorts of individuals (i.e., i) low to moderate risk; ii) high risk, iii) very high risk). | Continuous glucose data from the FreeStyle Libre device will be collected from each individual and analyzed for differences in glucose responses (i.e., "ups" and "downs") across the different study groups. | The device is worn for 14 days on each participant |
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Inclusion Criteria:
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Healthy adults and those at risk of developing prediabetes or type 2 diabetes.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klick Inc. | Toronto | Ontario | M4W 3R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40206722 | Derived | Kaufman JM, van Veen L, Fossat Y. Screening for Impaired Glucose Homeostasis: A Novel Metric of Glycemic Control. Mayo Clin Proc Digit Health. 2023 May 24;1(2):189-200. doi: 10.1016/j.mcpdig.2023.02.008. eCollection 2023 Jun. |
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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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Blood samples to collect glycated hemoglobin (HbA1c) measurements, fasting plasma glucose (FPG), and plasma glucose during an oral glucose tolerance test (OGTT).
| D004700 | Endocrine System Diseases |