NCT Number: NCT03463564
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.
Interested in participating?
Request Info18 year–30 year
All sexes
Interventional
Phase 4
Naples, 80138, Italy
Location status: Recruiting
Giuseppe Bellastella
SUB_INVESTIGATOR
Katherine Esposito
CONTACT
Katherine Esposito
PRINCIPAL_INVESTIGATOR
Maria Ida Maiorino
SUB_INVESTIGATOR
Michela Petrizzo
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.
Other names: CSII
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
Other names: MDI
Time frame: Baseline, 6 months, 12 months, 24 months
Within and between groups difference in HbA1c levels
Time frame: Baseline, 6 months, 12 months, 24 months
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
Within and between groups difference in glucose variability measured as coefficient of variation (CV).
Time frame: Baseline, 6 months, 12 months, 24 months
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
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: Through study completion, an average of 1 year
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: Baseline, 12 months, 24 months
Time frame: Baseline, 12 months, 24 months
Difference between groups in total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides
Time frame: Baseline, 12 months, 24 months
Time frame: Baseline, 12 months, 24 months
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).
Contact information is provided by the study sponsor or research team.
University of Campania Luigi Vanvitelli
Other
Effects of Insulin Pump Versus Multiple Daily Injections of Insulin on Glycemic and Metabolic Control in Type 1 Diabetic Patients Transitioned to the Adult Center: the Management and Technology for Transition Study (METRO)
Acronym: METRO
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