NCT05477030

Effect of Automated Insulin Delivery on Early-stage Diabetic Complications

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: University of Milan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2022-02-23
• Primary completion: 2023-01-31
• Completion: 2024-02-23
• First posted: 2022-07-28
• Last updated: 2022-07-28

Locations

1 site across 1 country: Italy