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| ID | Type | Description | Link |
|---|---|---|---|
| T32DK063703 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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This study is designed to look at how snacking during exercise may help prevent low blood sugars while subjects are on the "closed loop artificial pancreas." This system uses a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the sensor glucose level.
This study will be a randomized cross-over study as subjects will be studied under both study conditions - Closed Loop (CL) alone vs. CL + proactive snacking protocol). Differences in the nadir blood glucose levels during exercise between the two study conditions will be the primary outcome measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CL and exercise with proactive snacking | Experimental | Subject will consume oral glucose prior to starting exercise regimen while on the Medtronic MiniMed Closed Loop (CL) System |
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| CL and exercise without proactive snacking | Active Comparator | Subject will not consume oral glucose prior to starting exercise regimen while on the Medtronic MiniMed Closed Loop (CL) System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medtronic MiniMed Closed Loop (CL) System | Device | The Medtronic MiniMed Closed Loop (CL) System is an investigational system that uses some commercially available products. An investigational Enlite 2 glucose sensor measures the sensor glucose. The glucose sensor signal is sent to the insulin pump. From the insulin pump the sensor glucose is sent through the translator, which then relays the signal on to a controller. An Android Mobile Device (off the shelf) has the control algorithm installed. This device is known as the controller. The controller serves as the control center for the Android system, receiving data from the sensor and pump components, feeding the data to its control algorithm, issuing delivery commands to the pump to apply the algorithm's recommend therapy, and providing a means to monitor the system. |
| Measure | Description | Time Frame |
|---|---|---|
| Nadir blood glucose levels during exercise | Difference in the nadir blood glucose levels during exercise between the two study conditions: Closed Loop alone vs. Closed Loop+ snacking. | 75 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Episodes of hypoglycemia (blood glucose <60mg/dL) during exercise | Percentage of subjects that required treatment for hypoglycemia during the exercise period between the two study conditions | 75 minutes |
| Mean reduction in blood glucose during exercise |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Sherr, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D009043 | Motor Activity |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D062410 | Snacks |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D062407 | Meals |
| D005502 | Food |
| D000066888 |
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|
| Snacking | Other | Up to 45 g of oral glucose via Gatorade |
|
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Mean Reduction in blood glucose from baseline blood glucose during exercise |
| 75 minutes |
| Mean time blood glucose in target during exercise | Comparison of the mean time blood glucose levels were between 70-180mg/dL during exercise between the two study conditions | 75 minutes |
| Mean time blood glucose levels are in target during the overnight period | Comparison of the mean time blood glucose levels are in target (70-180mg/dL) during the overnight period after mid-afternoon exercise. | 17 hours |
| Mean glucose values | Comparison of the mean daytime and nighttime glucose values | 12 hours |
| Mean 24- hour glucose levels | Comparison of the mean 24- hour glucose levels | 24 hours |
| insulin delivery during CL therapy | Differences between insulin delivery during CL therapy during the two study conditions (pro-active snacking vs. no snacking) will be assessed. | 24 hours |
| Incremental meal-related glucose Area Under the Curve | Assessment of incremental meal related glucose area under the curve will be conducted. | 24 hours |
| Nadir glucose levels following the meals | Nadir glucose levels following meals will be compared between the two study conditions | 24 hours |
| Area under the curve meal-related plasma insulin level excursion following meals | Area under the curve meal-related insulin excursion following meals. | 24 hours |
| Nadir glucose levels overnight | Difference between nadir glucose levels between the two study conditions will be assessed. | 12 hours |
| Mean absolute relative difference (MARD) for each sensor | Calculation and comparison of the mean absolute relative difference for each sensor will be performed and comparisons between accuracy of the sensors will be done. | 24 hours |
| Mean daytime and nighttime glucose values | Comparison of the mean daytime and nighttime glucose levels | 24 hours |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |
| Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |