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

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ClinicalTrials.gov Identifier: NCT00147342
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : September 5, 2016
Information provided by (Responsible Party):

Study Description
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 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.

Condition or disease
Diabetes Mellitus, Type I

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 55 participants
Time Perspective: Prospective
Official Title: The Effect of Basal Insulin During Exercise on the Development of Hypoglycemia in Children With Type 1 Diabetes
Study Start Date : May 2005
Estimated Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147342

United States, California
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, United States, 94305-5208
United States, Colorado
Barbara Davis Center for Childhood Diabetes, University of Colorado
Aurora, Colorado, United States, 80010
United States, Connecticut
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, United States, 06519
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Jaeb Center for Health Research
Tampa, Florida, United States, 33647
United States, Iowa
Department of Pediatrics, University of Iowa Carver College of Medicine
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Jaeb Center for Health Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Chair: William V Tamborlane, M.D. Department of Pediatrics, Yale University School of Medicine
More Information

Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00147342     History of Changes
Other Study ID Numbers: DirecNet 007
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016

Keywords provided by Jaeb Center for Health Research:
Diabetes Mellitus, Type I
glucose monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases