Effect of Automated Insulin Delivery on Early-stage Diabetic Complications

Not Applicable

• Conditions: Type 1 Diabetes
• Interventions: Device: Medtronic MiniMed 780G with SmartGuard activation; Device: Medtronic MiniMed 780G without SmartGuard activation

• Registration Number: NCT05477030
• Lead Sponsor: University of Milan

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.

Study Timeline

• Study Start: 2022-02-23
• Study First Submitted: 2022-06-16
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-25
• Last Update Submitted: 2022-07-25
• Study First Posted: 2022-07-28
• Last Update Posted: 2022-07-28
• Primary Completion: 2023-01-31
• Study Completion: 2024-02-23

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group A (Intervention)	Medtronic MiniMed 780G with SmartGuard activation	Group treated with automated insulin delivery (advanced hybrid closed-loop)
Study Group B (Control)	Medtronic MiniMed 780G without SmartGuard activation	Group treated with predictive low glucose suspend (sensor augmented pump - PLGS)

Primary Outcome Measures

Name	Time	Method
Time in glycemic range 70-180 mg/dl	From Baseline to 26 weeks	time spent by the patient in glucose range
Glycated Hemoglobin (HbA1c)	From Baseline to 26 weeks	percentage of hemoglobin glycosylated

Secondary Outcome Measures

Name	Time	Method
Early microangiopathic damage markers: osteopontin	From Baseline to 26 weeks	osteopontin (pg/ml)
Early microangiopathic damage markers: sTNFR-1/2	From Baseline to 26 weeks	sTNFR-1/2 (pg/ml)
Early microangiopathic damage markers: B-2 microglobulin	From Baseline to 26 weeks	B-2 microglobulin (pg/ml)
Early microangiopathic damage markers: cystatin C	From Baseline to 26 weeks	cystatin C (ng/ml)
Early microangiopathic damage markers: neutrophil gelatinase-associated lipocalin	From Baseline to 26 weeks	neutrophil gelatinase-associated lipocalin (ng/ml)
Early microangiopathic damage markers: vWF levels	From Baseline to 26 weeks	vWF levels (ng/ml)
Endothelial disfunction	From Baseline to 26 weeks	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.

Trial Locations

Locations (1)

ASST FBF Sacco; 🇮🇹 Milan, Italy