Type 1 Diabetes
Conditions
Keywords
Automated insulin delivery, Type 1 Diabetes complications
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.
Interventions
DEVICEMedtronic 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)
DEVICEMedtronic MiniMed 780G without SmartGuard activation
Insulin pump implemented with alghoritm for low glucose insulin suspension (to reduce hypoglycemia rate)
Sponsors
University of Milan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Open label randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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: sTNFR-1/2 | From Baseline to 26 weeks | sTNFR-1/2 (pg/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. |
| Early microangiopathic damage markers: osteopontin | From Baseline to 26 weeks | osteopontin (pg/ml) |
| Early microangiopathic damage markers: B-2 microglobulin | From Baseline to 26 weeks | B-2 microglobulin (pg/ml) |
Countries
Italy
Contacts
Primary ContactElio Ippolito, MS
Backup ContactAntonio Rossi, MD
Outcome results
None listed