The Effect of Insulin During Exercise on the Development of Low Blood Sugar in Individuals With Type I Diabetes
Condition: Diabetes Mellitus, Type I
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Most children with type 1 diabetes have a drop in the blood sugar during exercise. This drop
      in the blood sugar can result in hypoglycemia (low blood sugar). In children using an insulin
      pump, there is an opportunity to reduce the basal insulin rate during exercise. This study is
      being conducted to determine if decreasing the insulin that is received during exercise will
      reduce the risk of hypoglycemia. We hope to learn more about how the body responds to
      hypoglycemia and to hyperglycemia (high blood sugar) when it occurs.

      As part of the study, children will have a visit on two different days. During each visit,
      children will exercise on a treadmill for about 60 minutes. During one of the visits, the
      children's basal rate will be continued during the exercise. During one visit, the basal
      insulin will be stopped. The blood sugar will be checked frequently during the exercise.
    

Detailed description: 
      Each child will have two study visits. The visits will be between 1 and 4 weeks apart. The
      child will come to the research unit at the hospital at about 11:30 a.m. and will have lunch
      in the clinic.

        -  If the child has had a severe hypoglycemia episode in the 2 weeks before a visit or is
           ill at the time of either visit, the visit will be rescheduled.

      The parent and child will be asked if they want to use a meter to test the child's hemoglobin
      A1c at home. If they want to do this, they will be given the meter and asked to test the
      child's A1c two times on the day before one of the visits. The two tests will be done at the
      same time and they will also be asked to check the child's blood sugar at the same time. The
      test involves a fingerstick similar to testing the blood sugar level with a home glucose
      meter.

      At the start of each visit, a continuous glucose sensor will be inserted under the skin. This
      is done either in the stomach area, side, or buttock depending on which area looks like it
      will work best for the child. A special cream may be used to numb the skin before this sensor
      is placed. At the end of each visit, the child will have the option of removing the sensor or
      wearing it home for continued use.

      During each visit, blood samples will be drawn frequently to measure glucose and other
      hormones. To make the blood sampling easier, a small tube, called a catheter, will be placed
      in a vein in the child's arm. A special cream may be used to numb the skin before the tube is
      placed. The tube will stay in the vein while the child is in the hospital. There may be some
      itching, stinging or pain from having the tube in the vein. However, there should be no pain
      when blood is drawn through the tube. If the tube stops working, a new one will need to be
      inserted.

        -  Blood sugar measurements will also be made with a home glucose meter. Instead of doing
           fingersticks, blood may be taken from the tube to measure the blood glucose with the
           home glucose meter.

        -  Blood samples will be taken and sent to a lab before, during, and after the exercise.

        -  In all, there will be 24 blood samples taken (12 samples during each of the visits).

      During each visit, the child will be asked to walk on a treadmill.

        -  Before and after walking on the treadmill, the child will be checked for urine and blood
           ketones.

        -  During each visit, in the late afternoon, the child will walk on the treadmill for 15
           minutes followed by a 5-minute rest period. This cycle of 15 minutes of exercise
           followed by a 5-minute rest period will be repeated 3 times for a total of 75 minutes.

        -  During one of the visits, the child's basal insulin rate will be stopped at the start of
           the exercise session and will be restarted about 45 minutes after the child stops
           exercising. During the other visit, the basal rate will be continued. A process like
           flipping a coin is used to decide the order of the visits.

        -  For both visits, the blood sugar needs to be between 120 and 200 at the start of the
           exercise. Between lunch and 4 p.m., the blood sugar will be checked a few times. To
           lower the blood sugar to this range, the child may be given insulin through the catheter
           to be used to draw the blood samples. No bolus insulin doses will be given with the
           child's pump after lunch. If the study doctors or nurses think the child's blood sugar
           may be too low to start exercise, a snack may be given to get the blood sugar to be in
           this range. If the blood sugar is too high or too low and cannot be corrected quickly
           enough, the exercise for that day may be postponed. If this happens, the child will need
           to return on another day.

        -  About 30 minutes after the exercise has ended, the child's blood sugar will be checked.
           If it is less than 250 mg/dL, a snack will be given and the last blood draw for the
           study will be made 15 minutes later. If the blood sugar is 250 mg/dL or higher, no snack
           will be given and the child's blood sugar will be checked in 15 minutes. At that time
           the child's insulin pump will be started if it was stopped, and a correction dose of
           insulin may be given.

        -  If at anytime after the exercise session the child's blood sugar is 325 mg/dL or higher,
           the child's insulin pump will be started and a correction dose of insulin may be given.

      During each visit, the child's blood sugar will be checked frequently. If the blood sugar
      drops to 65 mg/dL or lower, the hypoglycemia will be treated with carbohydrate. The child
      will not be treated if the blood sugar is higher than 65 mg/dL.

      Dinner will be given to the child at about 6:00 p.m. A bedtime snack will be given to the
      child to take home. The snack will be based on what the child would normally eat on a day
      with exercise.

      The child will be instructed to not have any more exercise for the rest of the day. The child
      will be given a home glucose meter and asked to check his or her blood sugar prior to the
      bedtime snack, at midnight, 3 a.m., and before breakfast the next morning. The child will be
      asked to treat any blood sugars 80 mg/dL or lower and to record the information on a log that
      will be provided.

      If the parent and child decided to do the A1c meter study at home, at one of the visits the
      study staff will check the A1c using the meter and the DCA2000. A fingerstick blood sample
      will also be sent to the central laboratory. The child's blood sugar will also be checked at
      the time of the tests.

      The catheter for the blood draws will be removed and each visit will end at about 6:30 p.m.
    

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