NCT04964128

Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing)	The AHCL system with Meal Gesture Dosing evaluated in this study includes a commercial/CE-Marked insulin pump with investigational software, and the Klue Health mobile app with investigational software (installed on Apple Watch) for meal gesture detection and micro dosing.

Timeline

• Start date: 2021-07-22
• Primary completion: 2022-06-10
• Completion: 2022-07-26
• First posted: 2021-07-15
• Last updated: 2023-09-13
• Results posted: 2023-07-03

Locations

1 site across 1 country: Israel

Regulatory

• FDA-regulated device study