Search / Trial NCT06236256

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

Launched by SHEBA MEDICAL CENTER · Jan 23, 2024

Trial Information

Current as of October 08, 2024

Recruiting

Keywords

Older Physical Capacity Frailty Cognitive Function

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 sen...

Gender

ALL

Eligibility 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

About Sheba Medical Center

Sheba Medical Center, located in Israel, is a leading academic medical institution renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, Sheba Medical Center leverages its multidisciplinary expertise and state-of-the-art facilities to conduct rigorous clinical studies aimed at improving patient outcomes and developing novel therapeutic interventions. The center's collaborative environment fosters partnerships with global research organizations, enhancing its ability to contribute to the scientific community and drive medical advancements across various fields. With a strong focus on patient safety and ethical standards, Sheba Medical Center is dedicated to translating research findings into practical applications that benefit patients worldwide.

Locations

Ramat Gan, , Israel

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0