Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes

Status Completed

Clinical Trial Summary

The purpose of this feasibility study is to evaluate subject safety of using the Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing) within the AHCL system in adult subjects with type 1 diabetes in a clinic setting.

Clinical Trial Description

This study is a single-center, single arm study in adult subjects with type 1 diabetes utilizing AHCL System with meal gesture detection and micro dosing (meal gesture dosing). Meal gesture dosing is a mode whereby meal announcements are not entered manually by the user. Instead, when meal gesture dosing is active, meal announcements are generated automatically by the system based on the detection of eating gestures and micro doses of insulin are given. Overall subject participation will be approximately 3 weeks to 6 months. A total of up to 40 subjects (aged 18-75) may be enrolled at one investigational center in Israel to have at least 16 subjects complete the study. The study consists of a run-in period and a study period. The run-in period is intended to allow subjects to become familiar with using the study pump system with the SmartGuard feature active and wearing the watch. Subjects should use the same insulin they will be using during the study period. During the first week of the study period, subjects will undergo a 5-day at-home baseline meal challenge at specific meals on each day. The Klue app will be set to monitoring-mode. After run-in period and completion of the 5-day at-home study period with baseline meal challenges, study subjects will check into the clinic for a 5-day (4 nights) intervention. Study subjects will wear the system with Klue meal gesture dosing activated for the entire duration of the 5-day intervention. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04964128
Study type	Interventional
Source	Medtronic Diabetes
Contact
Status	Completed
Phase	N/A
Start date	July 22, 2021
Completion date	July 26, 2022

View Details

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