Effect of Automated Insulin Delivery on Early-stage Diabetic Complications

NCT ID: NCT05477030

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2024-02-23

Brief 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.

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Study Group A (Intervention)

Group treated with automated insulin delivery (advanced hybrid closed-loop)

Group Type: ACTIVE_COMPARATOR

Medtronic MiniMed 780G with SmartGuard activation

Intervention Type: DEVICE

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

Study Group B (Control)

Group treated with predictive low glucose suspend (sensor augmented pump - PLGS)

Group Type: ACTIVE_COMPARATOR

Medtronic MiniMed 780G without SmartGuard activation

Intervention Type: DEVICE

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

Interventions

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)

Intervention Type: DEVICE

Medtronic MiniMed 780G without SmartGuard activation

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Paolo Fiorina, MD

MD, Ph.D, Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Fiorina, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

ASST-FBF-Sacco, University of Milan

Locations

ASST FBF Sacco

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Elio Ippolito, MS

Role: CONTACT

elio.ippolito@unimi.it

0239042648 ext. +39

Antonio Rossi, MD

Role: CONTACT

rossi.antonio@asst-fbf-sacco.it

0239044027 ext. +39

Facility Contacts

Elio Ippolito, Dr.

Role: primary

ippolito.elio@asst-fbf-sacco.it

02 39042648

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Other Identifiers

2022004

Identifier Type: -

Identifier Source: org_study_id