The Effect of Insulin During Exercise on the Development of Low Blood Sugar in Individuals With Type I Diabetes

Completed

Conditions studied: Diabetes Mellitus, Type I

In brief

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.

Key facts

Study ID

NCT00147342

Run by

Jaeb Center for Health Research

People needed

55

Starts

2005-05-01

Expected to finish

2005-12-01

Last updated by the study team

2016-09-05

Who can join

Age: 8 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of type 1 diabetes for at least 18 months (The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
• HbA1c <10.0% (The DCA2000 will be used to assess eligibility.)
• Age 8.0 to <18.0 years
• Weight >39.5 kg at reinfusion centers and >46.0 kg at discard centers
• BMI >5th and <95th percentiles for age and gender
• Stable insulin regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study (Stable is defined as no change in the overall insulin program, i.e., no change from SC injections to pump.)
• Insulin regimen involves use of an insulin pump
• Normal thyroid function (measured within the previous year)

You may not qualify if…

• A recent injury to body or limb, Addison's disease, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol
• Asthma which has been medically treated within the last year
• Current use of glucocorticoid medication (by any route of administration)
• Current use of a beta blocker medication
• Use of pseudoephedrine 48 hours prior to visit (if used in the 48 hours prior to the scheduled visit, the visit will be deferred)
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 2 weeks prior to a visit (if a severe episode occurs within 2 weeks prior to the scheduled visit, the visit will be deferred)
• Active infection (if at the time of the scheduled visit an infection is present, the visit will be deferred)
• Anticipating a significant change in exercise regimen between visits (i.e. starting or stopping an organized sport)

Where it is running

• Division of Pediatric Endocrinology and Diabetes, Stanford University — Stanford, California, United States
• Barbara Davis Center for Childhood Diabetes, University of Colorado — Aurora, Colorado, United States
• Department of Pediatrics, Yale University School of Medicine — New Haven, Connecticut, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Jaeb Center for Health Research — Tampa, Florida, United States
• Department of Pediatrics, University of Iowa Carver College of Medicine — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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