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

Diabetes Mellitus, Type 1 Clinical Trial

Official title: Advanced Hybrid Closed Loop System (780G) for People With Type 1 Diabetes Mellitus Patients Over the Age of 60: Efficacy in Improving Glucose Indices, Quality of Life, Cognitive Functions and Physical Capacity

Status Recruiting

Clinical Trial Summary

The trial is a randomized controlled, parallel group design study. Patients will be followed up during approximatively 12 months.

Patients will be randomized to either the MDI/CSII group which will continue their treatment as per routine procedures and the advanced Hybrid Closed Loop system (AHCL) group which will be connected to the Minimed 780G system. .

At the end of the 12 month study period, we will evaluate whether the AHCL system improved glucose indices in older individuals with Type 1 diabetes mellitus (T1DM) and assess whether the ACHL treatment improved physical capacity, frailty & sarcopenia indices as well as quality of life and cognitive functions.

Clinical Trial Description

All participants will go through a screening phase that includes an eligibility assessment, informed consent forms, Cognitive function assessment ( QoL questionnaire, WHO-5 questionnaire, MOCA, DSST, General Heath question), Sarcopenia/functional status/frailty assessment ( Timed up and Go , 6 min walk, 10 meter walk, Berg Balance Scale , Four Square Step Test , Grip Strength, 30 second chair stand, Fried Scale) and Lab tests.

After the screening, the participants will start a two week run in phase while continuing their routine procedures with an added unblinded G4 guardian standalone sensor.

sensor and data will be collected for 14 days and afterwards patients will be randomized to either the MDI/CSII group which will continue their treatment as per routine procedures and the AHCL group which will be connected to the Minimed 780G system. Both groups will have a similar number of visits in order to minimize bias. However, the AHCL group will have 2 additional visits to allow for patients to be trained on the AHCL system. After 6 months, both groups will be connected to the standalone sensor and glucose data will be collected after 2 weeks.

After 12 months of the study period, all participants will undergo primary assessments, blood tests questionnaires and will finish their part in the study. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

• NCT number: NCT06236256
• Study type: Interventional
• Source: Sheba Medical Center
• Contact: Tali Cukierman-Yaffe, Professor
• Phone: 0523824704
• Email: tcukierm@gmail.com
• Status: Recruiting
• Phase: N/A
• Start date: January 9, 2024
• Completion date: September 15, 2025