Evaluating the InPen in Pediatric Type 1 Diabetes — EMPoWER  

Type 1 Diabetes Clinical Trial

Official title: Evaluating the Utility of the "sMart" InPen Wireless-Enabled System to impRove Glycemic Control in Pediatric Type 1 Diabetes (EMPoWER Study)

Status Enrolling by invitation

Clinical Trial Summary

Type 1 Diabetes (T1D) is the most common form of diabetes affecting children, requiring lifelong administration of insulin to prevent complications. The incidence of T1D has increased more among African Americans, Hispanics, and Asian/Pacific Islanders compared to Caucasian youths in the past two decades. Despite advances in insulin delivery systems, fewer black and Hispanic children compared to white children with T1D use insulin pumps. Therefore, most minority children with T1D in urban areas require multiple daily injections (MDI) of insulin which may put them at increased risk of poor glycemic control. Although several factors contribute to worsening glycemic control in adolescents with T1D, studies have shown that missing doses of insulin at mealtimes is a major factor. Adolescents with T1D who use MDI with a basal-bolus regimen use formulas to calculate insulin doses that involve a four-step process. The complexity of determining insulin doses contributes to inaccuracies in both timing of doses and amount of insulin given, both of which can lead to hyperglycemia and hypoglycemia. The InPen™ Smart Insulin Pen System (Medtronics) was approved by the FDA for children of all ages with T1D in June 2020. The InPen is a Bluetooth-enabled smart insulin pen that helps with management of insulin dosing and tracking via capture of rapid-acting insulin doses and tracking of insulin in the body through the use of its companion app (free on Apple iOS and Android). The app includes a bolus calculator, which can lead to more accurate insulin dosing, which may improve glycemic control. The specific benefits of using the InPen include the following: simplifying insulin dose calculations, administering more accurate insulin doses, tracking insulin doses to help prevent hypoglycemia, providing reminders to administer insulin, and storing data in the InPen App that can be easily shared with diabetes healthcare teams to assist with adjusting insulin doses. The goal of this study is to determine if use of the InPen will improve glycemic control and diabetes numeracy in adolescents with uncontrolled T1D living in urban areas.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

• NCT number: NCT05515939
• Study type: Observational
• Source: Wayne State University
• Status: Enrolling by invitation
• Start date: September 9, 2022
• Completion date: January 2025