A Study of the Measurement of Blood Sugar Variation in Type 1 Diabetic Children, and Finding the Causes

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-000985
    Sponsor Protocol Number: 14-000985

About this study

The purpose of this study is to use multiple devices to measure blood sugar changes and the reasons for these changes in healthy and diabetic children.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

  • Type 1 diabetes diagnosed clinically at least 1 year prior to enrollment
    • Males must be Tanner stage 4-5
    • Females will have attained menarche 
    • currently on CSII with HbA1c <10 % 
    • physically active based on self-report 
    • no eating disorder 
    • high likelihood of compliance with protocol and completion of study 
    • absence of an intercurrent illness during the study period
  • Healthy children will need to meet the above criteria except for diabetes diagnosis and HbA1c criteria.
    • Male participants will be Tanner stage 4 or 5 
    • Females would have attained menarche
    • Healthy subjects will be recruited from the general population and can be siblings of type 1 diabetics

 

 

Exclusion Criteria

  • Factors confounding insulin action such as abnormal kidney and liver function, celiac disease and colitis 
  • Eating disorder 
  • Simultaneous involvement in another research study that would confound the current study
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent
  • Pregnancy
  • Any other condition that in the opinion of the study team would be concerning

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yogish Kudva, M.B.B.S.

Closed for enrollment

Contact information:

Shelly McCrady-Spitzer M.S.

(507)255-5916

McCradySpitzer.Shelly@mayo.edu

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CLS-20151752

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