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| ID | Type | Description | Link |
|---|---|---|---|
| DP3DK106826 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| DexCom, Inc. | INDUSTRY |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of the study is to demonstrate safety and feasibility of a decision support system aimed at improving activity-related insulin boluses in Type 1 Diabetes.
Subjects with Type 1 diabetes often need to adjust insulin boluses for activity since activity may increase the chance of hypoglycemia. The aims of this study is to make better bolus decisions by integrating knowledge about daily physical activity (PA) into bolus decisions. It is expected to decrease risk of hypoglycemia related to previous PA and provide better glucose control. The idea is to first obtain a carbohydrate ratio that is optimized around the everyday activity level of the patient and then adjust boluses when the activity for the day is different (above or below) than their regular activity level.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Activity on Board | Experimental | Blinded CGM data will be collected prior to the Experimental Admission to determine the insulin bolus that will be determined by the activity on board calculator. Subjects will wear a continuous glucose monitor during the study admission. |
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| Usual Diabetes Care | Placebo Comparator | Subjects will use their usual diabetes care, including basal rate, correction factor and carbohydrate-insulin ratio. Subjects will determine their own insulin usage during the Control Admission. Subjects will wear a continuous glucose monitor during the study admission. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activity on Board | Other | During the collection phase, the study team will collect information on glucose values, activity measures and insulin settings. This information will be used to determine the meal and correction boluses during the study admission. Subjects will wear a continuous glucose monitor during the data collection phase and study admission. |
| Measure | Description | Time Frame |
|---|---|---|
| Continuous Glucose Monitor metrics | Record CGM metrics with the primary outcome analysis of percentage time <70 mg/dL by CGM following exercise comparing the experimental to control admission | about 9-12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc D. Breton, Ph.D. | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 14, 2026 | |
| Reset | May 4, 2026 | |
| Release | Jun 2, 2026 | |
| Reset | Jun 25, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 14, 2026 | May 4, 2026 | |||
| Jun 2, 2026 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Usual Diabetes Care | Other | Subjects will perform their usual diabetes care including basal rate, meal and correction boluses during the study admission. Subjects will wear a continuous glucose monitor during the study admission. |
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| Jun 25, 2026 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |