Effect of Automated Insulin Delivery on Early-stage Diabetic Complications (AID-Comp)

July 25, 2022 updated by: Paolo Fiorina, MD, University of Milan

Effect of Automated Insulin Delivery With Advanced Closed-loop on Glucose Outcomes and Early-stage Diabetic Complications

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

New algorithms for the automation of insulin delivery (AID) are showing great benefit on glucose control in people with type 1 diabetes. Indeed, Hybrid closed loop (HCL) systems can improve HbA1c levels, percentage of time in defined glucose range, time below range and time over range, according to RCT and observational studies results. However, scientific evidences demonstrating potential benefits on the reduction of diabetes complications are limited regarding CSII or SAP with demonstrated reduction of cardiovascular mortality, improvement of albuminuria and peripheral nerve damage.

Data on AID effects on complications of diabetes are missing. In this study intermediate damage markers will be measured to assess potential effects of AID in comparison to sensor augmented pumps.

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20157
        • Recruiting
        • Asst Fbf Sacco
        • Principal Investigator:
          • Paolo Fiorina, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female patients
  • T1D patients above 18 years in CSII treatment for at least 3 months
  • HbA1c values between 6.0% and 9.5%
  • Disease duration ≥ 2 years
  • Written informed consent obtained from the patient

Exclusion Criteria:

  • Pregnancy
  • Participation to other clinical trials
  • A history of alcohol or drug abuse
  • Advanced diabetic nephropathy defined as presence of albuminuria ≥ 300 mg/g or eGFR < 60 ml/min/1,73m2
  • Proliferative Diabetic retinopathy or macular edema
  • Established Atherosclerotic Cardiovascular Disease (ASCVD) or history of heart failure
  • Presence of serious diseases or conditions which in the opinion of the Investigator makes patient non-eligible for the study
  • Hypoglycemia Unawareness (Clarke score > 4)
  • Patients unable to understand spoken and written Italian language

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Study Group A (Intervention)
Group treated with automated insulin delivery (advanced hybrid closed-loop)
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)
Active Comparator: Study Group B (Control)
Group treated with predictive low glucose suspend (sensor augmented pump - PLGS)
Device: Medtronic MiniMed 780G without SmartGuard activation
Insulin pump implemented with alghoritm for low glucose insulin suspension (to reduce hypoglycemia rate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in glycemic range 70-180 mg/dl
Time Frame: From Baseline to 26 weeks
time spent by the patient in glucose range
From Baseline to 26 weeks
Glycated Hemoglobin (HbA1c)
Time Frame: From Baseline to 26 weeks
percentage of hemoglobin glycosylated
From Baseline to 26 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early microangiopathic damage markers: sTNFR-1/2
Time Frame: From Baseline to 26 weeks
sTNFR-1/2 (pg/ml)
From Baseline to 26 weeks
Early microangiopathic damage markers: B-2 microglobulin
Time Frame: From Baseline to 26 weeks
B-2 microglobulin (pg/ml)
From Baseline to 26 weeks
Early microangiopathic damage markers: cystatin C
Time Frame: From Baseline to 26 weeks
cystatin C (ng/ml)
From Baseline to 26 weeks
Early microangiopathic damage markers: neutrophil gelatinase-associated lipocalin
Time Frame: From Baseline to 26 weeks
neutrophil gelatinase-associated lipocalin (ng/ml)
From Baseline to 26 weeks
Early microangiopathic damage markers: osteopontin
Time Frame: From Baseline to 26 weeks
osteopontin (pg/ml)
From Baseline to 26 weeks
Early microangiopathic damage markers: vWF levels
Time Frame: From Baseline to 26 weeks
vWF levels (ng/ml)
From Baseline to 26 weeks
Endothelial disfunction
Time Frame: From Baseline to 26 weeks

Endothelial-dependent dilation (EDD) is considered a marker of dysfunctional abnormalities involved in early phases of atherosclerosis development. Changes in EDD precede structural changes and occurs in the preclinical phase of vascular disease.

In the present study endothelial dependent dilation is assessed by color Doppler evaluation of flow increase after hyperemia.
From Baseline to 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milan

Investigators

  • Principal Investigator: Paolo Fiorina, MD, PhD, ASST-FBF-Sacco, University of Milan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2022

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

February 23, 2024

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

July 25, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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