Clinical trial NCT06236256: Advanced Hybrid Closed Loop System (AHCL) in Older Patients With Type 1 Diabetes Mellitus
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Older
Physical capacity
Frailty
Cognitive function
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Improvement of glucose measures in older individuals
timeFrame: 12 months
Secondary outcomes:
measure: Time up and go
timeFrame: 12 months
measure: 6 minute walk
timeFrame: 12 months
measure: Four Square Step Test (FSST)
timeFrame: 12 months
measure: Grip strength
timeFrame: 12 months
Other outcomes:
measure: Fried scale
timeFrame: 12 months
measure: Moca
timeFrame: 12 months
measure: DSS
timeFrame: 12 months
measure: WHO-5
timeFrame: 12 months
Locations:
city: Ramat-Gan
country: Israel
facility: Sheba medical center
Study officials:
References: