NCT00109434

Brief Summary

The main purpose of this study is to find out how often low blood sugar (hypoglycemia) happens during the night after exercise in the late afternoon. The study also will see if there are any factors that can predict if low blood sugar is going to develop. Blood samples will also be drawn to measure two hormones-glucagon and epinephrine (adrenaline)-to see how they are affected by exercise. Glucagon helps to raise the blood sugar when it is low. Epinephrine causes symptoms that make the person aware that the blood sugar is low. From the blood sample, other substances in the blood may also be measured to see how they are affected by exercise. A second purpose of the study is to find out whether exercise affects the accuracy of a continuous glucose sensor (CGMS made by Medtronic Minimed). The study will also look at the accuracy of different home glucose meters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2004

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2005

Completed
Last Updated

September 5, 2016

Status Verified

September 1, 2016

First QC Date

April 27, 2005

Last Update Submit

September 2, 2016

Conditions

Diabetes Mellitus, Type I

Keywords

exercisehypoglycemiaDiabetes Mellitus, Type Iglucose monitoring

Outcome Measures

Primary Outcomes (1)

  • Hypoglycemia defined as <=70 mg/dL.

Secondary Outcomes (1)

  • Changes in epinephrine and glucagon levels.

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of type 1 diabetes for at least 18 months
  • HbA1c \<10.0% as measured by the DCA2000.
  • Age 10.0 to \<18.0 years
  • Weight \>36.0 kg
  • BMI (body mass index) \>5th and \<95th percentiles for age/gender
  • Stable insulin regimen for at least 1 month and not anticipating a change prior to the subject's completion of the study
  • Insulin regimen involves either use of an insulin pump or Lantus (with short-acting insulin)
  • NPH or Lente, if part of the insulin regimen, is given only in the morning before breakfast
  • Normal hematocrit (within normal limits of local laboratory)
  • Normal thyroid function (measured within the previous year)
  • Parent/guardian and subject understand the study protocol and agree to comply with it
  • Informed Consent Form signed by the parent/guardian and Child Assent Form signed

You may not qualify if:

  • Insulin regimen includes Ultralente/Lente or NPH at times other than the morning before breakfast
  • 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 CRC admission (if used in the 48 hours prior to the scheduled second admission, the admission will be deferred)
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the 2 weeks prior to CRC admission (if a severe episode occurs within 2 weeks prior to the scheduled second admission, the admission will be deferred)
  • Active infection (if at the time of the planned second admission an infection is present, the admission will be deferred)
  • Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Division of Pediatric Endocrinology and Diabetes, Stanford University

Stanford, California, 94305-5208, United States

Location

Barbara Davis Center for Childhood Diabetes, University of Colorado

Denver, Colorado, 80262, United States

Location

Department of Pediatrics, Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Department of Pediatrics, University of Iowa Carver College of Medicine

Iowa City, Iowa, 52242, United States

Location

Related Publications (5)

  • Tsalikian E, Mauras N, Beck RW, Tamborlane WV, Janz KF, Chase HP, Wysocki T, Weinzimer SA, Buckingham BA, Kollman C, Xing D, Ruedy KJ; Diabetes Research In Children Network Direcnet Study Group. Impact of exercise on overnight glycemic control in children with type 1 diabetes mellitus. J Pediatr. 2005 Oct;147(4):528-34. doi: 10.1016/j.jpeds.2005.04.065.

    PMID: 16227041BACKGROUND

  • Weinzimer SA, Beck RW, Chase HP, Fox LA, Buckingham BA, Tamborlane WV, Kollman C, Coffey J, Xing D, Ruedy KJ; Diabetes Research in Children Network Study Group. Accuracy of newer-generation home blood glucose meters in a Diabetes Research in Children Network (DirecNet) inpatient exercise study. Diabetes Technol Ther. 2005 Oct;7(5):675-80; discussion 681-3. doi: 10.1089/dia.2005.7.675.

    PMID: 16241867RESULT

  • Diabetes Research in Children Network (DirecNet) Study Group. Impaired overnight counterregulatory hormone responses to spontaneous hypoglycemia in children with type 1 diabetes. Pediatr Diabetes. 2007 Aug;8(4):199-205. doi: 10.1111/j.1399-5448.2007.00248.x.

    PMID: 17659061RESULT

  • Diabetes Research In Children Network (Direcnet) Study Group; Buckingham BA, Kollman C, Beck R, Kalajian A, Fiallo-Scharer R, Tansey MJ, Fox LA, Wilson DM, Weinzimer SA, Ruedy KJ, Tamborlane WV. Evaluation of factors affecting CGMS calibration. Diabetes Technol Ther. 2006 Jun;8(3):318-25. doi: 10.1089/dia.2006.8.318.

    PMID: 16800753RESULT

  • Tansey MJ, Tsalikian E, Beck RW, Mauras N, Buckingham BA, Weinzimer SA, Janz KF, Kollman C, Xing D, Ruedy KJ, Steffes MW, Borland TM, Singh RJ, Tamborlane WV; Diabetes Research in Children Network (DirecNet) Study Group. The effects of aerobic exercise on glucose and counterregulatory hormone concentrations in children with type 1 diabetes. Diabetes Care. 2006 Jan;29(1):20-5. doi: 10.2337/diacare.29.1.20.

    PMID: 16373890RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor ActivityHypoglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • William V Tamborlane, M.D.

    Department of Pediatrics, Yale University School of Medicine

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2005

First Posted

April 28, 2005

Study Start

June 1, 2004

Study Completion

November 1, 2004

Last Updated

September 5, 2016

Record last verified: 2016-09

Locations

US(5)