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
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 120
Healthy Volunteers: f
View:

• Age over 60 years

• T1DM

• Willing to participate in a study for the specified duration

• Willing to perform ≥ 4 finger stick blood glucose measurements daily or connected to a basket approved CGM

• Willing to wear the system continuously throughout the study

• Treated with MDI/CSII (with exclusion of 780G or other hybrid closed systems)

• Lack of advanced complications of diabetes

Locations
Other Locations
Israel
Sheba medical center
RECRUITING
Ramat Gan
Contact Information
Primary
Tali Cukierman-Yaffe, Professor
tcukierm@gmail.com
0523824704
Time Frame
Start Date: 2024-01-09
Estimated Completion Date: 2025-09-15
Participants
Target number of participants: 40
Treatments
Experimental: AHCL group
Participants will be connected to the MiniMed 780G AHCL system for the 12 months study period. This group will have two additional visits to allow for patients to be trained on the AHCL system.
Placebo_comparator: MDI/CSII group
The patient will continue MDI/CSII treatment as per their routine procedures. At the beginning, middle and end of the stage they will be connected to a standalone sensor from which glucose data will be collected.
Related Therapeutic Areas
Sponsors
Leads: Sheba Medical Center

This content was sourced from clinicaltrials.gov

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