PRONTO-Peds Study

Study Type

Pediatrics

Study Purpose

Type 1 diabetes is the most common form of diabetes in children and adolescents. Currently, people with type 1 diabetes rely on insulin shots to maintain a normal blood sugar range. There is a need for more flexible treatment options for people with type 1 diabetes.

The PRONTO-Peds research study will assess the effectiveness of a new type of mealtime insulin for the treatment of type 1 diabetes. Researchers will compare this study drug to Humalog, an insulin already approved by the FDA, in children and adolescents.

About the Study

Eligible participants will visit the Pennington Biomedical Outpatient clinic to enroll and complete study visits. Participants will be randomly assigned to either the study drug or Humalog group and will take either medication for 6 months.

Study Design

Number of Visits:

  • 1 screening visit
  • A minimum of 7 study visits

Procedures:

  • Questionnaires
  • Physical exam
  • Medical history
  • Body measurements (height, weight, etc.)
  • Blood tests
  • Urine tests
  • Daily journals

Study Qualifications

To qualify for this research study, participants should:

  • Be 1 to 17 years old
  • Be diagnosed with Type 1 diabetes for at least 6 months

* You may not qualify for this study based on other eligibility criteria not listed. The study coordinator will go over this information in detail.

Study Duration

Participation in this study will last approximately 9 months.

Compensation

Compensation of up to $925 is available for the completion of this study.

Study Contact

To see if your child qualifies for this research study, a parent or guardian must complete the online screening form below. You may also call 225-763-3000 or email clinicaltrials@pbrc.edu.

If you think you may be eligible, please click the button below to screen online.

GET STARTED

Please do not fill out this questionnaire for anyone other than yourself unless you are their legal guardian.
If you know someone who may be interested please direct them to the site or have them call us directly at 225-763-3000.

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