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

  • End date
    Feb 23, 2024
  • participants needed
  • sponsor
    University of Milan
Updated on 4 October 2022
hemoglobin a1c


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.


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.

Condition Type 1 Diabetes
Treatment Medtronic MiniMed 780G with SmartGuard activation, Medtronic MiniMed 780G without SmartGuard activation
Clinical Study IdentifierNCT05477030
SponsorUniversity of Milan
Last Modified on4 October 2022


Yes No Not Sure

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

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
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