Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147342
Status:
COMPLETED
Last Update Posted:
2016-09-05
First Post:
2005-09-02
Brief Title:
The Effect of Insulin During Exercise on the Development of Low Blood Sugar in Individuals With Type I Diabetes
Sponsor:
Jaeb Center for Health Research
Organization:
Jaeb Center for Health Research
Study Overview
Official Title:
The Effect of Basal Insulin During Exercise on the Development of Hypoglycemia in Children With Type 1 Diabetes
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 childrens 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
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 childrens 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 1130 am 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 childs hemoglobin A1c at home If they want to do this they will be given the meter and asked to test the childs 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 childs 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 childs 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 childs 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 pm 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 childs pump after lunch If the study doctors or nurses think the childs 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 childs blood sugar will be checked If it is less than 250 mgdL 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 mgdL or higher no snack will be given and the childs blood sugar will be checked in 15 minutes At that time the childs 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 childs blood sugar is 325 mgdL or higher the childs insulin pump will be started and a correction dose of insulin may be given
During each visit the childs blood sugar will be checked frequently If the blood sugar drops to 65 mgdL or lower the hypoglycemia will be treated with carbohydrate The child will not be treated if the blood sugar is higher than 65 mgdL
Dinner will be given to the child at about 600 pm 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 am and before breakfast the next morning The child will be asked to treat any blood sugars 80 mgdL 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 childs 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 630 pm
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 childs hemoglobin A1c at home If they want to do this they will be given the meter and asked to test the childs 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 childs 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 childs 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 childs 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 pm 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 childs pump after lunch If the study doctors or nurses think the childs 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 childs blood sugar will be checked If it is less than 250 mgdL 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 mgdL or higher no snack will be given and the childs blood sugar will be checked in 15 minutes At that time the childs 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 childs blood sugar is 325 mgdL or higher the childs insulin pump will be started and a correction dose of insulin may be given
During each visit the childs blood sugar will be checked frequently If the blood sugar drops to 65 mgdL or lower the hypoglycemia will be treated with carbohydrate The child will not be treated if the blood sugar is higher than 65 mgdL
Dinner will be given to the child at about 600 pm 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 am and before breakfast the next morning The child will be asked to treat any blood sugars 80 mgdL 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 childs 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 630 pm
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HD041919 | None | None | None |
| HD041890 | None | None | None |
| HD041906 | None | None | None |
| HD041918 | None | None | None |
| HD041915 | None | None | None |
| HD041908 | None | None | None |