A Study to Assess the Effect of Smart Insulin Pens on Glycemic Control and Diabetes-related Burdens

Type 1 Diabetes Clinical Trial

Official title: Smart Insulin Pens: A Randomized, Crossover Prospective Interventional Pilot Study Assessing the Effect on Glycemic Control and Diabetes Related Burdens

Status Completed

Clinical Trial Summary

The purpose of this study is to see if the use of the InPen® for teens and young adults up to age 21 years with type 1 diabetes helps to decrease burden and improve glycemic control.

Clinical Trial Description

Investigators will perform a randomized, cross-over prospective interventional study. Half of the participants will be randomized to the InPen® and the other half will continue with their conventional insulin injection protocol. After 90 days, participants will switch to the second arm. Randomization will occur via block randomization. Teaching to use the InPen® will be done by Sarah Jackson, DO with supervision by Ana Creo, MD, which can be done by a telemedicine visit if it does not align with clinic visit. You will be followed for three months with hemoglobin A1c at the beginning and the end of the study. Data from the (Continuous Glucose Monitor (CGM) and InPen® will be analyzed including time in glucose goal range (70-180 mg/dL), glucose standard deviation, percentage of time that is spent high (>180-250 mg/dL), very high(> 250 mg/dL), low(54-70 mg/dL) and very low(<54 mg/dL), along with total daily insulin dose. Data on missed insulin doses will be assessed via data from the InPen®. You will be randomized to traditional injections we will ask them to record missed insulin doses weekly. You should still adjust insulin doses at home, like they do at baseline. If insulin adjustments are made while in one arm of the study they should still continue that dosing when they cross over. Investigators will also assess quality of life and fatigue related to technology with surveys prior to start of the study and at the end. Specifically, investigators will assess diabetes distress, transition readiness, and parental experience of childhood illness scales. Investigators will also utilize the insulin delivery satisfaction survey to assess how you view your current regimen and then how you view the effects of the InPen in managing your type 1 diabetes. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes

• NCT number: NCT05036343
• Study type: Interventional
• Source: Mayo Clinic
• Status: Completed
• Phase: N/A
• Start date: September 14, 2021
• Completion date: November 30, 2022