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Effect of Automated Insulin Delivery on Early-stage Diabetic Complications (AID-Comp)

Primary Purpose

Type 1 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Medtronic MiniMed 780G with SmartGuard activation
Medtronic MiniMed 780G without SmartGuard activation
Sponsored by
University of Milan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes focused on measuring Automated insulin delivery, Type 1 Diabetes complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ASST FBF SaccoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Study Group A (Intervention)

Study Group B (Control)

Arm Description

Group treated with automated insulin delivery (advanced hybrid closed-loop)

Group treated with predictive low glucose suspend (sensor augmented pump - PLGS)

Outcomes

Primary Outcome Measures

Time in glycemic range 70-180 mg/dl
time spent by the patient in glucose range
Glycated Hemoglobin (HbA1c)
percentage of hemoglobin glycosylated

Secondary Outcome Measures

Early microangiopathic damage markers: sTNFR-1/2
sTNFR-1/2 (pg/ml)
Early microangiopathic damage markers: B-2 microglobulin
B-2 microglobulin (pg/ml)
Early microangiopathic damage markers: cystatin C
cystatin C (ng/ml)
Early microangiopathic damage markers: neutrophil gelatinase-associated lipocalin
neutrophil gelatinase-associated lipocalin (ng/ml)
Early microangiopathic damage markers: osteopontin
osteopontin (pg/ml)
Early microangiopathic damage markers: vWF levels
vWF levels (ng/ml)
Endothelial disfunction
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.

Full Information

First Posted
June 16, 2022
Last Updated
July 25, 2022
Sponsor
University of Milan
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1. Study Identification

Unique Protocol Identification Number
NCT05477030
Brief Title
Effect of Automated Insulin Delivery on Early-stage Diabetic Complications
Acronym
AID-Comp
Official Title
Effect of Automated Insulin Delivery With Advanced Closed-loop on Glucose Outcomes and Early-stage Diabetic Complications
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
February 23, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Milan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Automated insulin delivery, Type 1 Diabetes complications

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open label randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study Group A (Intervention)
Arm Type
Active Comparator
Arm Description
Group treated with automated insulin delivery (advanced hybrid closed-loop)
Arm Title
Study Group B (Control)
Arm Type
Active Comparator
Arm Description
Group treated with predictive low glucose suspend (sensor augmented pump - PLGS)
Intervention Type
Device
Intervention Name(s)
Medtronic MiniMed 780G with SmartGuard activation
Intervention Description
Insulin pump implemented with alghoritm for automatic modulation of insulin delivery (to increase time in glucose range 70-180 mg/dl)
Intervention Type
Device
Intervention Name(s)
Medtronic MiniMed 780G without SmartGuard activation
Intervention Description
Insulin pump implemented with alghoritm for low glucose insulin suspension (to reduce hypoglycemia rate)
Primary Outcome Measure Information:
Title
Time in glycemic range 70-180 mg/dl
Description
time spent by the patient in glucose range
Time Frame
From Baseline to 26 weeks
Title
Glycated Hemoglobin (HbA1c)
Description
percentage of hemoglobin glycosylated
Time Frame
From Baseline to 26 weeks
Secondary Outcome Measure Information:
Title
Early microangiopathic damage markers: sTNFR-1/2
Description
sTNFR-1/2 (pg/ml)
Time Frame
From Baseline to 26 weeks
Title
Early microangiopathic damage markers: B-2 microglobulin
Description
B-2 microglobulin (pg/ml)
Time Frame
From Baseline to 26 weeks
Title
Early microangiopathic damage markers: cystatin C
Description
cystatin C (ng/ml)
Time Frame
From Baseline to 26 weeks
Title
Early microangiopathic damage markers: neutrophil gelatinase-associated lipocalin
Description
neutrophil gelatinase-associated lipocalin (ng/ml)
Time Frame
From Baseline to 26 weeks
Title
Early microangiopathic damage markers: osteopontin
Description
osteopontin (pg/ml)
Time Frame
From Baseline to 26 weeks
Title
Early microangiopathic damage markers: vWF levels
Description
vWF levels (ng/ml)
Time Frame
From Baseline to 26 weeks
Title
Endothelial disfunction
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elio Ippolito, MS
Phone
0239042648
Ext
+39
Email
elio.ippolito@unimi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Rossi, MD
Phone
0239044027
Ext
+39
Email
rossi.antonio@asst-fbf-sacco.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Fiorina, MD, PhD
Organizational Affiliation
ASST-FBF-Sacco, University of Milan
Official's Role
Principal Investigator
Facility Information:
Facility Name
ASST FBF Sacco
City
Milan
ZIP/Postal Code
20157
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elio Ippolito, Dr.
Phone
02 39042648
Email
ippolito.elio@asst-fbf-sacco.it
First Name & Middle Initial & Last Name & Degree
Paolo Fiorina, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Automated Insulin Delivery on Early-stage Diabetic Complications

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