Status:
RECRUITING
Insulin Pump vs Multiple Daily Injections of Insulin and Glyco-metabolic Control in Type 1 Diabetic Patients
Lead Sponsor:
University of Campania Luigi Vanvitelli
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-30 years
Phase:
PHASE4
Brief 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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03463564
Start Date
January 1 2016
End Date
December 1 2026
Last Update
March 15 2018
Active Locations (1)
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1
Unit of Diabetes
Naples, Italy, 80138