Advanced Hybrid Closed Loop System (AHCL) in Older Patients With Type 1 Diabetes Mellitus

NARecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

January 9, 2024

Primary Completion Date

June 15, 2025

Study Completion Date

September 15, 2025

Conditions
Diabetes Mellitus, Type 1
Interventions
DEVICE

MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system

The MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system consists of the following devices: MiniMed 780G insulin pump, Guardian Link (4) transmitter and the Guardian Sensor (4). It is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values. Study participants will be connected to the system and glucose data will be collected throughout the 12 month study period.

OTHER

MDI/CSII

Participants in the control group with continue their routine procedures that include eighter Multiple daily insulin injections (MDI) treatment or different kinds of Continuous subcutaneous insulin infusion (CSII) pumps depending on their treatment before the study. The participants will be connected to a standalone sensor at the start, middle and end of the study and glucose data will be collected.

Trial Locations (1)

52621

RECRUITING

Sheba medical center, Ramat Gan

All Listed Sponsors
lead

Sheba Medical Center

OTHER_GOV