Safety and patient perception of an insulin pen with simple memory function for children and adolescents with type 1 diabetes--the REMIND study.
OBJECTIVE
NovoPen Echo * is a durable pediatric insulin pen incorporating half-unit dosing starting at 0.5 units and a last-dose memory function. The REMIND † (Rating the Effects of Memory function in pediatric INsulin Devices) study primarily examined the safety of this new device by collecting data on technical complaints (TCs) related to adverse reactions (ARs) during use in a clinical setting.


METHODS
REMIND was an observational, multicenter study involving patients with type 1 diabetes on injection therapy, aged 2-18 years, from Canada, Finland, Israel and Sweden. Questionnaires and case report forms were completed at baseline and after using NovoPen Echo for 12-18 weeks.


RESULTS
In total, 358 patients participated and 315 completed. No serious ARs were reported. Three ARs related to TCs were reported, equated to one every 29 patient-years. Most patients found it 'easy' or 'somewhat easy' to read amount (99%) and hours lapsed (95%) since last dose using the memory function. The proportion of children self-injecting was significantly higher (71%) compared with those on previous device (66%, p=0.006). 80% of physicians answers reported they could train users in ≤10 minutes.


CONCLUSIONS
Only three device safety events were reported for NovoPen Echo. Physicians found it easy and quick to educate users. Patients/caregivers missed fewer injections and reported greater confidence in managing their insulin injections. As this was an observational study without controls or centralized laboratory testing, caution should be used in interpreting outcomes in glycemic control. Further studies are required to examine the effects of features such as memory function and half-unit dosing on HbA1c and hypoglycemia over a longer time period.
Department of Pediatrics, Queen Silvia Children's Hospital, Gothenburg, Sweden. peter.adolfsson@vgregion.se
Peter
P
Adolfsson
Riitta
R
Veijola
Celine
C
Huot
Helle Doré
HD
Hansen
Jacob Bo
JB
Lademann
Moshe
M
Phillip
D000293:Adolescent; D001786:Blood Glucose / Q000032:analysis; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007273:Injections, Intramuscular / Q000295:instrumentation*; D007328:Insulin / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D011795:Surveys and Questionnaires
D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007328:Insulin; C517652:hemoglobin A1c protein, human