Comparing insulin pump therapy to multiple daily insulin injections for young adults with type 1 diabetes
Official title: Effects of Insulin Pump Versus Multiple Daily Injections of Insulin on Glycemic and Metabolic Control in Type 1 Diabetic Patients Transitioned to the Adult Center: the Management and Technology for Transition Study (METRO)
Run by University of Campania Luigi Vanvitelli · NCT03463564 · Data updated 2026-11-12
This study tests whether using an insulin pump works better than daily insulin shots for young adults with type 1 diabetes who have trouble controlling their blood sugar.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 30 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University of Campania Luigi Vanvitelli Academic / other |
| Locations | 1 site (Naples) |
| Status | Recruiting |
| Started | January 2016 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | March 15, 2018 |
| Trial ID | NCT03463564 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are young adults with type 1 diabetes for at least 12 months, experiencing persistent high HbA1c levels and significant glucose variability.
✕Probably not a fit
Patients who have previously used an insulin pump or have severe chronic diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effects of continuous subcutaneous insulin infusion (CSII) therapy compared to multiple daily injections (MDI) on glycemic and metabolic control in young adults transitioning from pediatric to adult diabetes care. It targets individuals with type 1 diabetes who have struggled to maintain glycemic control despite optimized education and therapy. The study aims to determine which method of insulin delivery is more effective in managing blood sugar levels and reducing variability during this critical transition phase.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective insulin delivery method for improving glycemic control in young adults with type 1 diabetes.
How similar studies have gone: While insulin pump therapy and multiple daily injections are both established methods for managing type 1 diabetes, this specific comparison during the transition phase has not been extensively studied, making it a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * T1DM for at least 12 months * persistent HbA1c levels ≥ 7.5% (58 mmol/mol) despite optimized education therapy, * recurrent severe hypoglycemic episodes or high glucose variability * willingness to wear the insulin pump Exclusion Criteria: * previous use of insulin pump * pregnancy or planning to become pregnant in the next 2 years, * lack of ability to use the study devices * history of severe chronic diseases * recent or concomitant use of corticosteroids * drug or alcohol abuse * psychiatric complaints that interfere with the correct use of the devices
Where it's running
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Unit of Diabetes
Naples, Italy Recruiting
Study contacts
- Principal investigator: Katherine Esposito — University of Campania Luigi Vanvitelli
- Study coordinator: Katherine Esposito
- Email: katherine.esposito@unicampania.it
- Phone: +390815665031
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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VV-14300: a gene therapy approach for adults with type 1 diabetes not well controlled on an automated insulin system
This trial tests VV-14300 in adults with type 1 diabetes who aren’t reaching their blood sugar goals despite using an automated insulin delivery system.
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New gene therapies VV-14299 and VV-14300 for adults with Type 1 Diabetes failing automated insulin delivery
This study tests VV-14299 and VV-14300, or VV-14300 alone, in adults with long-standing Type 1 Diabetes whose blood sugar remains poorly controlled despite using an automated insulin delivery system.
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Oral verapamil in newly diagnosed children and teens with type 1 diabetes
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Preventing device-related skin rashes in kids with type 1 diabetes using hydrocolloid vs silicone patches
This study tests whether silicone-based or hydrocolloid patches help prevent recurring skin irritation from insulin pumps or CGMs in children and teens with type 1 diabetes.
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AI-assisted remote insulin pump optimization for people with type 1 diabetes
This study tests an AI-powered tool that suggests insulin pump settings for people with type 1 diabetes, with doctor-approved recommendations delivered to a mobile app.
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Near-sensor insulin delivery with CGM in people with type 1 diabetes
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.