Background: The use of insulin pumps in pediatric patients with type 1 diabetes(T1D) has expanded, with lack of data comparing between the different devices. Objective: to compare prospectively glycemic control, technical difficulties and quality of life (QOL) between 3 pump devices during the first year of use . Methods: a prospective observational trial, based on clinical data retrieved during 12 months of follow- up. Inclusion criteria included T1D patients, ages 1-18 years, who started pump therapy as part of their clinical care in 4 university affiliated medical centers. The devices fully reimbursed by national health insurance are: MiniMed™ 640G , MiniMed® Veo™, Animas® Vibe®, and Abbott Omnipod®. Comparison parameters included quality of life (QOL), frequency of technical difficulties, skin reactions, discontinuation rate, glycated hemoglobin (HBA1C), mean glucose, total daily insulin dose (TDD) , pump setting parameters and BMI.
Study Type
OBSERVATIONAL
Enrollment
60
Technical difficulties differences
All patients were asked 5 questions regarding monthly frequency of technical problems including the need to use extra sets and the level of pain at catheter insertion
Time frame: 2 years from patient first enrollment
Quality Of Life (QOL)
QOL assessment was performed utilizing The Diabetes Treatment Satisfaction Questionnaires (DTSQ) for teens and for parents, separately \[14\]. The teens DTSQ contained 12 items scores on six-point scales, of which 9 were summed, the parents DTSQ contained 14 items, of which 9 were summed. Maximal grade was 42.
Time frame: 2 years from patient first enrollment
Skin reactions differences
skin assessment at the pump insertion site (itching and redness).
Time frame: 2 years from patient first enrollment
Discontinuation rate differences
Comparison between constant pump users and those who discontinued
Time frame: 2 years from patient first enrollment
Glycemic control and metabolic parameters differences: Insulin TDD
The difference in glycemic control parameters and metabolic parameters after 3, 6 and 12 months of follow up, between the pumps devices. Insulin TDD, as reported by pump printout data
Time frame: 2 years from patient first enrollment
Glycemic control and metabolic parameters differences: HbA1c%
The difference in HbA1c% as measured by each center ll local lab.
Time frame: 2 years from patient first enrollment
Glycemic control and metabolic parameters differences:Glucose Mean & SD
Glucose Mean \& SD as recorded by SMBG
Time frame: 2 years from patient first enrollment
Glycemic control and metabolic parameters differences:Number of SMBG per day
Data derived from data recorded by SMBG
Time frame: 2 years from patient first enrollment
Glycemic control and metabolic parameters differences:BMI SDS
according to Center for Disease Control (CDC) growth charts scale
Time frame: 2 years from patient first enrollment
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