MedTrace Logo

AHCL System Initiation in T1D Patients naïve to Technology

NCT04616391 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-11-05

No results posted yet for this study

Summary

The primary objective of this study is to evaluate whether the MiniMed 780G AHCL system improves glycemic control and Quality of Life (QoL) perception in adult individuals with T1D and naïve to CSII and CGM technologies.

The trial is a two-centers, randomized controlled, parallel group study. Patients will be followed up during approximatively 3 months.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

insulin pump Medtronic 780G

Patients from the AHCL group will use the MiniMed 780G AHCL system. This system is already CE-marked. The AHCL system will be initiated first in Manual Mode (i.e. without AHCL control) with suspend before low feature (Visit 1). The AHCL system will be initiated in Auto Mode (i.e. with AHCL control) at Visit 2 with the settings in the below table. The Insulin to Carb ratio (ICR) and the Active Insulin Time (AIT) may be adjusted by the physician during the study. The glucose target may not be adjusted, unless in case of safety concerns. The patients may not adjust system settings without consulting with the physician. At each visit, the AHCL system data will be downloaded and reviewed by the physician. The patient interaction with the system will be evaluated, included sensor calibration, bolus management (before the meals and for corrections as needed), alarms and Auto Mode exits.

Sponsors & Collaborators

  • Medtronic Poland Spółka z ograniczoną odpowiedzialnością

    collaborator INDUSTRY

  • University of Rzeszow

    collaborator OTHER

  • Jagiellonian University

    lead OTHER

Principal Investigators

  • Tomasz Klupa, Prof · Hospital University; jagiellonian University Medical College

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2021-03-31
Completion
2021-07-01

More Related Trials

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 NCT04616391 on ClinicalTrials.gov