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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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The goal of this clinical trial is to evaluate the efficacy and safety of Medtronic 780G automated insulin delivery system in adult persons with type 1 diabetes and gastroparesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medtronic 780G group | Experimental |
| |
| Usual care | No Intervention | Participants will continue either multiple daily injections or non-AID insulin pumps |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic 780G AID | Device | Participants in Medtronic AID treatment group will use it for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range (70-180 mg/dL) | Percentage of time that sensor glucose values are within the target range of 70-180 mg/dL, as measured by continuous glucose monitoring (CGM). | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Change in glycated hemoglobin (HbA1c) measured using standard laboratory methods. | Baseline to 3 months |
| Mean Sensor Glucose | Mean sensor glucose value derived from CGM data. |
| Measure | Description | Time Frame |
|---|---|---|
| Severe Hypoglycemia | Number of severe hypoglycemic events requiring assistance from another person. | 3 months |
| Diabetic Ketoacidosis | Number of diabetic ketoacidosis events defined by standard clinical criteria. |
Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sana Kalaji | Contact | 317-278-6017 | skalaji@iu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Health, Univeristy hospital | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D007316 | Insemination, Artificial, Heterologous |
| ID | Term |
|---|---|
| D007315 | Insemination, Artificial |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
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| Baseline to 3 months |
| Time in Tight Target Range (70-140 mg/dL) | Percentage of time that sensor glucose values are between 70 and 140 mg/dL (TTIR), measured by CGM. | Baseline to 3 months |
| Time Above Range | Percentage of time that sensor glucose values are >180 mg/dL and >250 mg/dL, measured by CGM. | Baseline to 3 months |
| Time Below Range | Percentage of time that sensor glucose values are <70 mg/dL and <54 mg/dL, measured by CGM. | Baseline to 3 months |
| Glucose Variability | Glucose variability assessed by the standard deviation (SD) of sensor glucose values from CGM data. | Baseline to 3 months |
| 3 months |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 | Investigative Techniques |
| D007314 | Insemination |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |