An observational study in T1DM, sponsored by Assaf-Harofeh Medical Center. Completed. Open to participants aged Up to 21 Years. Per ClinicalTrials.gov, last updated 2018-10-05.
Sponsored by Assaf-Harofeh Medical Center · Observational
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 60 is below the median of 120 across 748 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Assaf-Harofeh Medical Center is the lead sponsor of 258 studies on the registry; 40 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population included all individuals with T1D ages 0-20 years who switched management modality from MDI to pump as part of their clinical care, and were managed by the pediatric diabetes teams from the AWeSoMe Study Group ( four pediatric diabetes multidisciplinary clinics in Israel; Assaf Harofeh Medical Center, E. Wolfson Medical Center, Edmond and Lily Safra Children's Hospital, and Maccabi National Juvenile Diabetes Center).
Exclusion Criteria:
Individuals with T1D ages 0-20 years who switched management modality from MDI to pump as part of their clinical care and were followed up prospectively in the next 12 months.
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
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Assaf-Harofeh Medical Center