Using an advanced insulin delivery system for older patients with Type 1 diabetes
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
This study is testing whether an advanced insulin delivery system can help older people with Type 1 diabetes manage their blood sugar better and improve their overall health and quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 60 Years to 120 Years |
| Sex | All |
| Sponsor | Sheba Medical Center Government |
| Locations | 1 site (Ramat-Gan) |
| Trial ID | NCT06236256 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of the MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system in older patients with Type 1 diabetes mellitus over a 12-month period. Participants will be randomized into two groups: one continuing their routine treatment and the other using the AHCL system. The study will assess improvements in glucose control, physical capacity, frailty, cognitive function, and quality of life. Participants will undergo various assessments, including cognitive and functional status evaluations, throughout the study.
Who should consider this trial
Good fit: Ideal candidates are individuals over 60 years old with Type 1 diabetes who are willing to participate in the study and adhere to the monitoring requirements.
Not a fit: Patients with severe concurrent illnesses or advanced complications of diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve glucose management and overall quality of life for older patients with Type 1 diabetes.
How similar studies have performed: Other studies have shown promising results with hybrid closed loop systems in diabetes management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age over 60 years 2. T1DM 3. Willing to participate in a study for the specified duration 4. Willing to perform ≥ 4 finger stick blood glucose measurements daily or connected to a "basket approved" CGM 5. Willing to wear the system continuously throughout the study 6. Treated with MDI/CSII (with exclusion of 780G or other hybrid closed systems) 7. Lack of advanced complications of diabetes Exclusion Criteria: 1. Severe concurrent illness 2. Laboratory abnormalities, or medications that might affect study participation, 3. Severe renal impairment 4. Any illness that may interfere with study procedures
Where this trial is running
Ramat-Gan
- Sheba medical center — Ramat-Gan, Israel (Recruiting)
Study contacts
- Study coordinator: Tali Cukierman-Yaffe, Professor
- Email: tcukierm@gmail.com
- Phone: 0523824704
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.