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

Sheba Medical Center

Status: Enrolling

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system; Other: MDI/CSII

Study type: Interventional

Funder types: Other

Identifiers

NCT06236256

0205-23-SMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 60 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

AHCL group

Experimental group

Description:

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.

Treatment:

Device: MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system

MDI/CSII group

Placebo Comparator group

Description:

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.

Treatment:

Other: MDI/CSII