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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Continuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.
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
Unit of Diabetes
Naples, Italy
RECRUITINGHbA1c change
Within and between groups difference in HbA1c levels
Time frame: Baseline, 6 months, 12 months, 24 months
Change in mean amplitude glucose excursions (MAGE
Within and between groups difference in glucose variability measured as mean amplitude of glucose excursions (MAGE).
Time frame: Baseline, 6 months, 12 months, 24 months
Change in coefficient of variation (CV)
Within and between groups difference in glucose variability measured as coefficient of variation (CV).
Time frame: Baseline, 6 months, 12 months, 24 months
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
Time frame: Baseline, 6 months, 12 months, 24 months
Change in glucose variability
Within and between groups difference in time in the euglycemic range, defined as the minutes per day spent in glucose levels ranging between 70-180 mg/dL
Time frame: Baseline, 6 months, 12 months, 24 months
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)
Time frame: Through study completion, an average of 1 year
Change in weight
Time frame: Baseline, 12 months, 24 months
Change in lipid profile
Difference between groups in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
Time frame: Baseline, 12 months, 24 months
Total daily insulin doses/Kg
Time frame: Baseline, 12 months, 24 months
Diabetes treatment satisfaction
In order to measure satisfaction with diabetes treatment regimens, we used the self-reported Diabetes Treatment Satisfaction Questionnaire. This instrument aims to assess levels of satisfaction in subjects using different treatment strategies. The questionnaire consists of eight questions: six questions addresses general satisfaction with a score from 0 to 6 for each question (0 = worst), that has to be computed in a total score ranging from 0 (=worst) to 36 (=best); among the remaining two questions, which has to be computed separately as two subscales, one concerns the perception of hyperglycemic events and another the perception of hypoglycemic events, both with a score from 0 (none of the time) to 6 (most of the time).
Time frame: Baseline, 12 months, 24 months
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