Insulearn Feasibility With MDI — InsuLearn  

Type 1 Diabetes Mellitus Clinical Trial

Official title: Feasibility of a Bolus Calculator Without Carbohydrate Counting in T1D Patients Under MDI Therapy: A Supervised Randomized Controlled Trial

Status Not yet recruiting

Clinical Trial Summary

This is a 24-hour, randomized, crossover, single-center trial where participants are randomized to either start with the InsuLearn intervention or the usual care (UC) intervention. In the InsuLearn intervention, insulin doses are optimized using data collected in a 4-weeks at home data collection period.

Clinical Trial Description

Following recruitment and screening, 12 participants will be randomized to either the InsuLearn→UC or the UC→InsuLearn sequence. Participants will be trained in the use of CGM (Dexcom G6 or Guardian™ 4), smart insulin pen (SIP, InPen™, Medtronic) and the InPen™ bolus calculator phone application. The InPen™ application will be set to the "meal estimation" mode where the user can select the meal category: if it is a breakfast/lunch/dinner/snack and if it has low/med/high carb amount. During the one-month data collection period, participants will be asked to use the InPen™ app to log and deliver their insulin doses. Before the hotel admission, InsuLearn will analyze the collected data to learn a new optimized insulin dose for each meal category. InsuLearn will generate a report of suggested new insulin doses that will be reviewed, approved, or changed by the study physician as needed. In the 24-h supervised interventions (hotel admission), the participant will consume three standardized meals, a med-carb lunch, a high-carb dinner, and low-carb breakfast. The insulin dose delivered in each admission will be either calculated by participants as per their UC or is as provided by the InsuLearn approved report. The two interventions are combined into a 2-day admission without a washout period. ;

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

• NCT number: NCT06411548
• Study type: Interventional
• Source: University of Virginia
• Contact: Jasmeen Dhillon
• Phone: (434) 466-7942
• Email: jkd9ud@uvahealth.org
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Completion date: December 31, 2024