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

NCT06236256 | Unknown FDA Device

• 1 other identifier: 0205-23-SMC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Older; Physical capacity; Frailty; Cognitive function

Outcome Measures

Primary Outcomes (1)

• Improvement of glucose measures in older individuals

  The primary objective of this study is to evaluate whether the AHCL (MiniMed 780G) system improves glucose indices in older (above 60 years of age) individuals with Type 1 diabetes mellitus. Glucose differences between the groups will be monitored and evaluated by difference in the percentage of time spent within range with sensor glucose (SG) between 70-180 mg/dL (Primary outcome), time in hyperglycemic range SG \> 250 mg/dL , SG \> 180 mg/dL, time in hypoglycemic range with SG \< 70 mg/dL , SG \< 54 mg/dL as well as difference in the glycemic variability, mean glucose level and change in HbA1c levels.

  12 months

Secondary Outcomes (4)

• Time up and go

  12 months

• 6 minute walk

  12 months

• Four Square Step Test (FSST)

  12 months

• Grip strength

  12 months

Other Outcomes (4)

• Fried scale

  12 months

• Moca

  12 months

• DSS

  12 months

Study Arms (2)

AHCL group

EXPERIMENTAL

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.

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

MDI/CSII group

PLACEBO COMPARATOR

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.

Other: MDI/CSII

Interventions

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

The MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system consists of the following devices: MiniMed 780G insulin pump, Guardian Link (4) transmitter and the Guardian Sensor (4). It is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values. Study participants will be connected to the system and glucose data will be collected throughout the 12 month study period.

AHCL group

MDI/CSII OTHER

Participants in the control group with continue their routine procedures that include eighter Multiple daily insulin injections (MDI) treatment or different kinds of Continuous subcutaneous insulin infusion (CSII) pumps depending on their treatment before the study. The participants will be connected to a standalone sensor at the start, middle and end of the study and glucose data will be collected.

MDI/CSII group

Eligibility Criteria

• Age: 60 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Lack of advanced complications of diabetes

You may not qualify if:

• Severe concurrent illness
• Laboratory abnormalities, or medications that might affect study participation,
• Severe renal impairment
• Any illness that may interfere with study procedures

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Frailty

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Tali Cukierman-Yaffe, Professor

CONTACT

0523824704; tcukierm@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: February 1, 2024
• Study Start: January 9, 2024
• Primary Completion: June 15, 2025
• Study Completion: September 15, 2025
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

IL (1)