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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
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.
Up to 45 g of oral glucose via Gatorade
Yale University School of Medicine
New Haven, Connecticut, United States
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.
Time frame: 75 minutes
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
Time frame: 75 minutes
Mean reduction in blood glucose during exercise
Mean Reduction in blood glucose from baseline blood glucose during exercise
Time frame: 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
Time frame: 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.
Time frame: 17 hours
Mean glucose values
Comparison of the mean daytime and nighttime glucose values
Time frame: 12 hours
Mean 24- hour glucose levels
Comparison of the mean 24- hour glucose levels
Time frame: 24 hours
insulin delivery during CL therapy
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Differences between insulin delivery during CL therapy during the two study conditions (pro-active snacking vs. no snacking) will be assessed.
Time frame: 24 hours
Incremental meal-related glucose Area Under the Curve
Assessment of incremental meal related glucose area under the curve will be conducted.
Time frame: 24 hours
Nadir glucose levels following the meals
Nadir glucose levels following meals will be compared between the two study conditions
Time frame: 24 hours
Area under the curve meal-related plasma insulin level excursion following meals
Area under the curve meal-related insulin excursion following meals.
Time frame: 24 hours
Nadir glucose levels overnight
Difference between nadir glucose levels between the two study conditions will be assessed.
Time frame: 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.
Time frame: 24 hours
Mean daytime and nighttime glucose values
Comparison of the mean daytime and nighttime glucose levels
Time frame: 24 hours