NCT03463564RecruitingPhase 4
Insulin Pump vs Multiple Daily Injections of Insulin and Glyco-metabolic Control in Type 1 Diabetic Patients
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)
Source: ClinicalTrials.gov · Last updated 15 Mar 2018 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The transition from the Pediatric clinic to the adult care is a challenging period for young adults with type 1 diabetes, due to the high risk of poor glycemic control. Achieving the glycemic target without hypoglycemia and/or large glucose excursions is of paramount importance for type 1 diabetic patients, who have high variability of daily glucose levels . Both insulin pump therapy and multiple daily injections of insulin are recommended strategy to achieve glycemic control in type 1 diabetes; however, no studies investigated the effects of insulin pump vs insulin injections on glycol-metabolic outcomes in the transition phase. The aim of this study was to evaluate the effects of continuous subcutaneous insulin infusion (CSII) therapy, as compared with multiple daily injections of insulin (MDI), on glycemic and metabolic control, in young type 1 diabetic patients transitioned to the adult diabetes care.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- First submitted
- 19 Feb 2018
- Start date
- Jan 2016
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Diseases
- Type 1 diabetes
- NCT number
- NCT03463564
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 150
- From Jan 2016 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous use of insulin pump
- recent or concomitant use of corticosteroids
- drug or alcohol abuse
Other illness
- history of severe chronic diseases
- psychiatric complaints that interfere with the correct use of the devices
Other
- pregnancy or planning to become pregnant in the next 2 years,
- lack of ability to use the study devices
Who the study is looking for
- 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
Age in the registry: 18 years to 30 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Unit of Diabetes Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.