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

University of Milan

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Device: Medtronic MiniMed 780G with SmartGuard activation; Device: Medtronic MiniMed 780G without SmartGuard activation

Study type: Interventional

Funder types: Other

Identifiers

NCT05477030

2022004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Study Group A (Intervention)

Active Comparator group

Description:

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

Treatment:

Device: Medtronic MiniMed 780G with SmartGuard activation

Study Group B (Control)

Active Comparator group

Description:

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

Treatment:

Device: Medtronic MiniMed 780G without SmartGuard activation