An observational study in Diabetes Mellitus, Type I, sponsored by Jaeb Center for Health Research. Completed at 5 sites in United States. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2016-09-05.
Sponsored by Jaeb Center for Health Research · Observational
The main purpose of this study is to find out how often low blood sugar (hypoglycemia) happens during the night after exercise in the late afternoon. The study also will see if there are any factors that can predict if low blood sugar is going to develop. Blood samples will also be drawn to measure two hormones-glucagon and epinephrine (adrenaline)-to see how they are affected by exercise. Glucagon helps to raise the blood sugar when it is low. Epinephrine causes symptoms that make the person aware that the blood sugar is low. From the blood sample, other substances in the blood may also be measured to see how they are affected by exercise.
A second purpose of the study is to find out whether exercise affects the accuracy of a continuous glucose sensor (CGMS made by Medtronic Minimed).
The study will also look at the accuracy of different home glucose meters.
Many children and adults with type 1 diabetes have a drop in the blood sugar during exercise. When someone has low blood sugar, the body tries to return the blood sugar to normal. Some studies show that after exercise, the blood sugar may drop later in the day or during the night. However, it is not known how often this happens. Also, not enough is known about how exercise affects blood sugar or the awareness of low blood sugar.
Some studies in adults have shown that exercise may affect the body's natural response to low blood sugar and exercise in the future.
For this study, each subject will have two in-patient hospital stays 1 to 4 weeks apart, each lasting about 24 hours: one with no exercise and one with a 75-minute exercise session in the late afternoon. (The order of the exercise and sedentary days will be determined at random.)
Prior to each hospital admission, each subject will keep a detailed diary of insulin use and hypoglycemia for one week.
On each of the two admissions, the insulin regimens and diet will be as similar as possible.
On each of the 2 admissions, the following will occur:
On the exercise day only,
10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.
This study's enrollment of 50 is below the median of 233 across 2,218 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Jaeb Center for Health Research is the lead sponsor of 126 studies on the registry; 17 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 14 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hypoglycemia defined as <=70 mg/dL.
Changes in epinephrine and glucagon levels.
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Jaeb Center for Health Research