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

NCT06236256 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-01

No results posted yet for this study

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

Interventions

DEVICE

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

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.

OTHER

MDI/CSII

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.

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-09
Primary Completion
2025-06-15
Completion
2025-09-15
FDA Device
Yes

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06236256 on ClinicalTrials.gov