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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-30
SponsorUniversity of Campania Luigi Vanvitelli

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Insulin pump
  • Insulin injections

Treatment groups

150 Participants
are divided into 2 treatment groups