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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
52
Insulin pump implemented with alghoritm for automatic modulation of insulin delivery (to increase time in glucose range 70-180 mg/dl)
Insulin pump implemented with alghoritm for low glucose insulin suspension (to reduce hypoglycemia rate)
ASST FBF Sacco
Milan, Italy
RECRUITINGTime in glycemic range 70-180 mg/dl
time spent by the patient in glucose range
Time frame: From Baseline to 26 weeks
Glycated Hemoglobin (HbA1c)
percentage of hemoglobin glycosylated
Time frame: From Baseline to 26 weeks
Early microangiopathic damage markers: sTNFR-1/2
sTNFR-1/2 (pg/ml)
Time frame: From Baseline to 26 weeks
Early microangiopathic damage markers: B-2 microglobulin
B-2 microglobulin (pg/ml)
Time frame: From Baseline to 26 weeks
Early microangiopathic damage markers: cystatin C
cystatin C (ng/ml)
Time frame: From Baseline to 26 weeks
Early microangiopathic damage markers: neutrophil gelatinase-associated lipocalin
neutrophil gelatinase-associated lipocalin (ng/ml)
Time frame: From Baseline to 26 weeks
Early microangiopathic damage markers: osteopontin
osteopontin (pg/ml)
Time frame: From Baseline to 26 weeks
Early microangiopathic damage markers: vWF levels
vWF levels (ng/ml)
Time frame: From Baseline to 26 weeks
Endothelial disfunction
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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.
Time frame: From Baseline to 26 weeks