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Effect of Automated Insulin Delivery on Early-stage Diabetic Complications

NCT05477030 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2022-07-28

No results posted yet for this study

Summary

Aim of this study is to verify the effects of an advanced HCL (Medtronic Minimed™ 780G) compared to SAP with PLGS on metabolic outcomes and markers of early microvascular damage in a population of adults with T1D previously treated with CSII. Evaluation of endothelial disfunction and autonomic neuropathy will also be performed.

Conditions

Interventions

DEVICE

Medtronic MiniMed 780G with SmartGuard activation

Insulin pump implemented with alghoritm for automatic modulation of insulin delivery (to increase time in glucose range 70-180 mg/dl)

DEVICE

Medtronic MiniMed 780G without SmartGuard activation

Insulin pump implemented with alghoritm for low glucose insulin suspension (to reduce hypoglycemia rate)

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Principal Investigators

  • Paolo Fiorina, MD, PhD · ASST-FBF-Sacco, University of Milan

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-23
Primary Completion
2023-01-31
Completion
2024-02-23

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT05477030 on ClinicalTrials.gov