Study to Determine the Relationship Between Exercise and Hypoglycemia in Children With Type 1 Diabetes
Condition: Diabetes Mellitus, Type I
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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:

        -  A CGMS sensor will be inserted and calibrated.

        -  An intravenous catheter for the collection of blood samples will be inserted.

        -  Blood sugar measurements will be made with an Ultra, BD Logic, and Freestyle meter every
           half hour beginning at 10:00 p.m. through 6:00 a.m.

        -  Blood samples for glucagon, epinephrine, and glucose will be collected hourly from 10:00
           p.m. to 6:00 a.m.

      On the exercise day only,

        -  In the morning, the subject will run on the treadmill for about 5 minutes to determine
           the settings needed to achieve a heart rate of 140.

        -  Exercise will begin at approximately 4:00PM and will consist of 15 minutes on a
           treadmill at a heart rate of approximately 140 followed by a 5-minute rest period. This
           cycle will be repeated 3 more times for a total of four 15-minute exercise periods with
           5-minute rest periods in between (75 minutes total). A heart rate monitor will be worn
           throughout the time of exercise to ascertain the effort put forth.

        -  BG (blood glucose) measurements will be made using the Ultra, BD Logic, and Freestyle
           meters (1) prior to starting the exercise, (2) during each of the 3 rest periods, (3)
           immediately following the exercise session, and (4) at 15 minute intervals for one hour
           following the completion of the exercise. Blood samples will be collected for the
           central lab at the times of sampling for glucagon and epinephrine.
    

Time perspective: Prospective
Keywords: exercise; hypoglycemia; Diabetes Mellitus, Type I; glucose monitoring