Comparing insulin pump therapy to multiple daily insulin injections for young adults with type 1 diabetes
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)
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 |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 30 Years |
| Sex | All |
| Sponsor | University of Campania Luigi Vanvitelli Academic / other |
| Locations | 1 site (Naples) |
| Trial ID | NCT03463564 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who have previously used an insulin pump or have severe chronic diseases may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Naples
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.