The Effect of Insulin During Exercise on the Development of Low Blood Sugar in Individuals With Type I Diabetes
The Effect of Basal Insulin During Exercise on the Development of Hypoglycemia in Children With Type 1 Diabetes
7 other identifiers
observational
55
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2005
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedSeptember 5, 2016
September 1, 2016
September 2, 2005
September 2, 2016
Conditions
Keywords
Eligibility Criteria
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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, 94305-5208, United States
Barbara Davis Center for Childhood Diabetes, University of Colorado
Aurora, Colorado, 80010, United States
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, 06519, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
Jaeb Center for Health Research
Tampa, Florida, 33647, United States
Department of Pediatrics, University of Iowa Carver College of Medicine
Iowa City, Iowa, 52242, United States
Related Publications (2)
Diabetes Research in Children Network (DirecNet) Study Group; Tsalikian E, Kollman C, Tamborlane WB, Beck RW, Fiallo-Scharer R, Fox L, Janz KF, Ruedy KJ, Wilson D, Xing D, Weinzimer SA. Prevention of hypoglycemia during exercise in children with type 1 diabetes by suspending basal insulin. Diabetes Care. 2006 Oct;29(10):2200-4. doi: 10.2337/dc06-0495.
PMID: 17003293RESULTFox L, Dontchev M, Ruedy K, Beck R, Kollman C, Messer L, Coffey J, Wilson D, Doyle E, Tamborlane W, Steffes M; DirecNet Study Group. Relative inaccuracy of the A1cNow in children with type 1 diabetes. Diabetes Care. 2007 Jan;30(1):135-7. doi: 10.2337/dc06-0972. No abstract available.
PMID: 17192346RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
William V Tamborlane, M.D.
Department of Pediatrics, Yale University School of Medicine
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
May 1, 2005
Study Completion
December 1, 2005
Last Updated
September 5, 2016
Record last verified: 2016-09