Background: Intensive insulin treatment allows a good metabolic control and prevents long-term complications. Basal-bolus regimen is the best treatment for children with type 1 diabetes T1D but requires several insulin injections a day. The needle-fear and discomfort felt by the child and parents/caregivers for insulin administration is one of the main obstacle to good compliance.
Objective and hypotheses: To compare glycemic control and satisfaction with a new injection port (I-PORT), through which insulin can be injected subcutaneously from a syringe/pen without repeated needle punctures of the skin, to multiple daily insulin administration (MDI).
Method: Twenty subjects (5 M, mean age 9.5±2.6 years, mean T1DM-duration 3.1±2.3 years) were enrolled. They were randomly assigned to group A (starting using I-PORT) and B (on traditional MDI). Participants were trained to change the device every 3 days and to inject both basal and bolus insulins through it. Subjects were invited to move to a strict basal-bolus regimen (requiring more insulin injections for meals, snacks, and hyperglycaemic peaks). After 8 weeks the two groups switched to the other arm. HbA1c was detected at baseline, before the cross-over and at the end of the study (16 weeks). A questionnaire was provided to collect satisfaction about the new device.
Results: Two participants dropped out and were excluded from the analysis. Mean baseline HbA1c was 8.02±1% (64±11 mmol/mol), mean HbA1c after I-PORT period 7.53±0.7% (58±8 mmol/mol) whereas mean HbA1c on traditional MDI 7.92±0.9% (63±9.3 mmol/mol) (P=0.09). No dka or severe hypoglycaemic episodes occurred. At the end of the study 15/20 (75%) of participants appreciated I-PORT and decided to maintain it.
Conclusion: In this pilot study I-PORT has proven to be safe and seems to improve metabolic control in children during real-life setting. Attenuating the discomfort of multiple injections through the device allowed to follow more strictly basal-bolus regimen. Children and adolescents seem to tolerate and appreciate this device.
18 Sep 2014 - 20 Sep 2014