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

Last updated: March 13, 2018
Sponsor: University of Campania "Luigi Vanvitelli"
Overall Status: Active - Recruiting

Phase

4

Condition

Diabetes Mellitus, Type 1

Diabetes And Hypertension

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT03463564
24012014-33
  • Ages 18-30
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 150
Study Start date:
January 01, 2016
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Unit of Diabetes

    Naples, 80138
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.