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RECRUITING
NCT03463564
PHASE4

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

Sponsor: University of Campania Luigi Vanvitelli

View on ClinicalTrials.gov

Summary

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.

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)

Key Details

Gender

All

Age Range

18 Years - 30 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2016-01

Completion Date

2026-12

Last Updated

2018-03-15

Healthy Volunteers

No

Interventions

DEVICE

Insulin pump

Continuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.

DRUG

Insulin injections

Four injections of insulin daily consisting in three bolus of a rapid-acting analog lispro or aspart before breakfast, lunch and dinner and one injection of insulin glargine or degludec at bed-time of basal insulin

Locations (1)

Unit of Diabetes

Naples, Italy