Clinical trial NCT05477030: Effect of Automated Insulin Delivery on Early-stage Diabetic Complications
Official title: Effect of Automated Insulin Delivery With Advanced Closed-loop on Glucose Outcomes and Early-stage Diabetic Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Automated insulin delivery
Type 1 Diabetes complications
Lead sponsor: University of Milan
Sponsor class: OTHER
First posted: 2022-07-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomized controlled trial
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Time in glycemic range 70-180 mg/dl
timeFrame: From Baseline to 26 weeks
measure: Glycated Hemoglobin (HbA1c)
timeFrame: From Baseline to 26 weeks
Secondary outcomes:
measure: Early microangiopathic damage markers: sTNFR-1/2
timeFrame: From Baseline to 26 weeks
measure: Early microangiopathic damage markers: B-2 microglobulin
timeFrame: From Baseline to 26 weeks
measure: Early microangiopathic damage markers: cystatin C
timeFrame: From Baseline to 26 weeks
measure: Early microangiopathic damage markers: neutrophil gelatinase-associated lipocalin
timeFrame: From Baseline to 26 weeks
measure: Early microangiopathic damage markers: osteopontin
timeFrame: From Baseline to 26 weeks
measure: Early microangiopathic damage markers: vWF levels
timeFrame: From Baseline to 26 weeks
measure: Endothelial disfunction
timeFrame: From Baseline to 26 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: ASST FBF Sacco
Study officials:
affiliation: ASST-FBF-Sacco, University of Milan
name: Paolo Fiorina, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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