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Could Your Child with Type 1 Benefit from AID?

Last updated: 6/21/21
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By Julia Kenney

A remote six-month clinical trial is recruiting 150 children between the ages of two to five whose families are interested in trying automated insulin delivery. The study will evaluate the use of automated insulin delivery in young children to see if it improves Time in Range and other health metrics.  

Clinical Trials Identifier: NCT04796779

Trial Name: The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children with Type 1 Diabetes

Diabetes Type: Pediatric Type 1

What is the trial testing?

This trial is evaluating whether the use of Tandem’s Control-IQ automated insulin delivery (AID) system can improve glucose management in children between the ages of two to five years old with type 1 diabetes. AID systems aim to make insulin dosing easier and reduce hypoglycemia and hyperglycemia to improve Time in Range (TIR). Families in the US can participate remotely and do not need to attend in-person clinic visits.

In this 26-week trial, 150 participating children will be split into two groups – an experimental group and a comparison group. The experimental group will use the Control-IQ AID system throughout the entire study, including a Tandem t:slim X2 insulin pump with Control-IQ technology and a Dexcom G6 continuous glucose monitor (CGM). In the comparison group, participants will continue using their previous form of insulin delivery (insulin pump or multiple daily injections of insulin, also called MDI) and a Dexcom G6 CGM for the first 13 weeks, before switching to Control-IQ for the second half of the trial.

What is the trial measuring?

The trial will primarily evaluate participants’ Time in Range (TIR). Researchers will also assess A1C and other CGM metrics, such as Time Above Range, Time Below Range, and glucose variability over the two 13-week periods.

Why is the trial new and important?

AID systems have been shown to help adults and youth with diabetes manage their glucose levels more effectively by automatically adjusting insulin delivery. The technology can improve TIR, reduce hypoglycemia and hyperglycemia, and improve quality of life by easing the stress associated with insulin dosing and injections.

Research on the use of AID systems in children is important given the prevalence of diabetes in young people. More than 18,000 kids and adolescents under the age of 20 are estimated to be diagnosed with type 1 diabetes every year. For young children with diabetes, their families must carefully manage their glucose levels and insulin dosing. AID systems may significantly improve the health of young children, as well as quality of life for the entire family.

Trial length: 6-7 months

Trial location: The trial is fully remote and recruiting in the United States.

Are you interested?

Your child may be eligible for this study if they:

  • Have had type 1 diabetes for at least six months

  • Are two to five years old

  • Have a parent or guardian who can successfully use the devices and understands emergency procedures for severe hypoglycemia

  • Can switch to Novolog or Humalog insulin (if not already using these)

  • Take at least five units of insulin per day

  • Weigh at least 20 pounds

  • Do not have a history of severe hypoglycemia or DKA in the last three to six months

You can see a full list of eligibility and exclusion criteria here

For more information: Please contact John Lum on the PEDAP study team (813-975-8690, pedap@jaeb.org)

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