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

Sponsor
University of Milan (Other)
Overall Status
Recruiting
CT.gov ID
NCT05477030
Collaborator
(none)
52
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Medtronic MiniMed 780G with SmartGuard activation
  • Device: Medtronic MiniMed 780G without SmartGuard activation
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Open label randomized controlled trialOpen label randomized controlled trial
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effect of Automated Insulin Delivery With Advanced Closed-loop on Glucose Outcomes and Early-stage Diabetic Complications
Actual Study Start Date :
Feb 23, 2022
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Feb 23, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Study Group A (Intervention)

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

Device: Medtronic 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)
Active Comparator: Study Group B (Control)

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

Device: Medtronic MiniMed 780G without SmartGuard activation
Insulin pump implemented with alghoritm for low glucose insulin suspension (to reduce hypoglycemia rate)

Outcome Measures

Primary Outcome Measures

  1. Time in glycemic range 70-180 mg/dl [From Baseline to 26 weeks]

    time spent by the patient in glucose range

  2. Glycated Hemoglobin (HbA1c) [From Baseline to 26 weeks]

    percentage of hemoglobin glycosylated

Secondary Outcome Measures

  1. Early microangiopathic damage markers: sTNFR-1/2 [From Baseline to 26 weeks]

    sTNFR-1/2 (pg/ml)

  2. Early microangiopathic damage markers: B-2 microglobulin [From Baseline to 26 weeks]

    B-2 microglobulin (pg/ml)

  3. Early microangiopathic damage markers: cystatin C [From Baseline to 26 weeks]

    cystatin C (ng/ml)

  4. Early microangiopathic damage markers: neutrophil gelatinase-associated lipocalin [From Baseline to 26 weeks]

    neutrophil gelatinase-associated lipocalin (ng/ml)

  5. Early microangiopathic damage markers: osteopontin [From Baseline to 26 weeks]

    osteopontin (pg/ml)

  6. Early microangiopathic damage markers: vWF levels [From Baseline to 26 weeks]

    vWF levels (ng/ml)

  7. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 ASST FBF Sacco Milan Italy 20157

Sponsors and Collaborators

  • University of Milan

Investigators

  • Principal Investigator: Paolo Fiorina, MD, PhD, ASST-FBF-Sacco, University of Milan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paolo Fiorina, MD, MD, Ph.D, Full Professor, University of Milan
ClinicalTrials.gov Identifier:
NCT05477030
Other Study ID Numbers:
  • 2022004
First Posted:
Jul 28, 2022
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Paolo Fiorina, MD, MD, Ph.D, Full Professor, University of Milan
Automated insulin delivery
Type 1 Diabetes complications
Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Complications

Study Results

No Results Posted as of Jul 28, 2022