Phase 4 Type 1 Diabetes Trial, Recruiting (NCT03463564)

Phase 4 Type 1 Diabetes Trial, Recruiting NCT03463564 Sponsor: University of Campania Luigi Vanvitelli Condition: Type 1 Diabetes

Printed from Voxsanity (voxsanity.com.au) — NCT03463564 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Type 1 Diabetes

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

People who have had Type 1 diabetes for at least 12 months
People whose average blood sugar levels (measured by a test called HbA1c) have stayed at 7.5% or higher, even after receiving the best available diabetes education and care
People who experience repeated episodes of dangerously low blood sugar, or whose blood sugar levels change a lot throughout the day
People who are willing to wear an insulin pump throughout the trial

Who may not be able to join:

People who have previously used an insulin pump
People who are pregnant, or who plan to become pregnant within the next 2 years
People who are not able to use the devices involved in the study
People who have a history of serious long-term illnesses
People who have recently used, or are currently using, steroid medications (such as corticosteroids)
People who have a problem with alcohol or drug misuse
People who have mental health conditions that could interfere with the correct use of the study devices

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.

Last synced 19 July 2026

Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Katherine Esposito, University of Campania Luigi Vanvitelli

Phone: +390815665031

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT03463564

Sponsor: University of Campania Luigi Vanvitelli

Phase: Phase 4

Status: Recruiting

Condition: Type 1 Diabetes

Trial contact: +390815665031

More information: https://clinicaltrials.gov/study/NCT03463564

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

People who have had Type 1 diabetes for at least 12 months
People whose average blood sugar levels (measured by a test called HbA1c) have stayed at 7.5% or higher, even after receiving the best available diabetes education and care
People who experience repeated episodes of dangerously low blood sugar, or whose blood sugar levels change a lot throughout the day
People who are willing to wear an insulin pump throughout the trial

Who may not be able to join:

People who have previously used an insulin pump
People who are pregnant, or who plan to become pregnant within the next 2 years
People who are not able to use the devices involved in the study
People who have a history of serious long-term illnesses
People who have recently used, or are currently using, steroid medications (such as corticosteroids)
People who have a problem with alcohol or drug misuse
People who have mental health conditions that could interfere with the correct use of the study devices

Important: Always verify eligibility with the trial site directly before applying.

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 19 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 4

Sponsor

University of Campania Luigi Vanvitelli

Registry

ClinicalTrials.gov

Start date

1 January 2016

Est. completion

1 December 2026

Where this trial is recruiting

🇮🇹 Italy

Primary endpoints

HbA1c change; Change in mean amplitude glucose excursions (MAGE; Change in coefficient of variation (CV); Change in standard deviation (SD) of mean glucose levels; Change in glucose variability

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov