Actively Recruiting

Phase 4
Age: 18Years - 30Years
All Genders
NCT03463564

Insulin Pump vs Multiple Daily Injections of Insulin and Glyco-metabolic Control in Type 1 Diabetic Patients

Led by University of Campania Luigi Vanvitelli · Updated on 2018-03-15

150

Participants Needed

1

Research Sites

569 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Insulin Pump vs Multiple Daily Injections of Insulin and Glyco-metabolic Control in Type 1 Diabetic Patients

Who Can Participate

Age: 18Years - 30Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Type 1 diabetes diagnosed for at least 12 months
  • HbA1c levels 7.5% or higher despite optimized education therapy
  • Experience of recurrent severe hypoglycemic episodes or high glucose variability
  • Willingness to wear an insulin pump
Not Eligible

You will not qualify if you...

  • Previous use of an insulin pump
  • Pregnancy or planning pregnancy within the next 2 years
  • Inability to use the study devices
  • History of severe chronic diseases
  • Recent or current corticosteroid use
  • Drug or alcohol abuse
  • Psychiatric issues interfering with device use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Unit of Diabetes

Naples, Italy, 80138

Actively Recruiting

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Research Team

K

Katherine Esposito

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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