Children 6 – 13 with Type 1 Diabetes needed for AP Study

IRB/UVA Tracking #
21318
Principal Investigator
Melissa Schoelwer
Contact
Melissa Schoelwer
Contact Email
Contact Phone
434.924.9144
Official Trial Title
The International Diabetes Closed Loop (iDCL) trial: Clinical Acceptance of the Artificial Pancreas in Pediatrics, A Study of t:slim X2 with Control-IQ Technology (DCLP5-PEds)
Study Description

The Center for Diabetes Technology seeks children ages 6 - 13 with Type 1 Diabetes (T1DM) for a research
study. The purpose of the study is to learn whether an investigational automated insulin delivery system for
children with type 1 diabetes can safely improve blood glucose control.
You may be eligible for this study if:
• Ages 6 – 13 years old
• Weigh between 55 lb and 308 lb
• Be diagnosed with Type 1 Diabetes (T1DM)
• Using insulin therapy to manage T1DM for at least one year
• Have insulin parameters (carbohydrate ratio, correction factor) used to calculate meal insulin boluses
Study involves using a study continuous glucose monitoring (CGM), a study insulin pump (Tandem t:slim X2
with Control-IQ), and an experimental software algorithm (“closed-loop”) to automatically give insulin and
control blood glucose. This study will involve approximately 7 months of data collection and approximately
one clinic visit per month, with each clinic visit lasting about 1 – 2 hours.
Study-related exams, tests, devices, and supplies will be provided at no cost to you during participation in the
study.

Compensation

You will be compensated a total of $375 at the completion of the study or you will be compensated for the portions of the study completed at study discharge. - Completion of Screening Visit: $25.00 - Completion of Run-In / Randomization Visit: $50.00 - Completion of 2-Week Visit: $50.00 - Completion of 8-Week Visit: $50.00 - Completion of 16-Week Visit: $100.00 - Completion of Extension Phase Data Collection: $100.00