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.
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
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
Parallel
Insulin pump
DeviceContinuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.
Insulin injections
DrugFour 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
HbA1c change
Within and between groups difference in HbA1c levels
Change in mean amplitude glucose excursions (MAGE
Within and between groups difference in glucose variability measured as mean amplitude of glucose excursions (MAGE).
Change in coefficient of variation (CV)
Within and between groups difference in glucose variability measured as coefficient of variation (CV).
Change in standard deviation (SD) of mean glucose levels
Within and between groups difference in glucose variability measured as standard deviation (SD) of mean glucose levels
Occurrence of hypoglycemic events
Number of events of mild hypoglycemia (glucose levels below 70 mg/dl), or severe hypoglycemia (below 54 mg/dl or each episode of low glucose levels requiring assistance)
Change in weight
Change in lipid profile
Difference between groups in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
Total daily insulin doses/Kg
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