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| Name | Class |
|---|---|
| Wolfson Medical Center | OTHER_GOV |
| Sheba Medical Center | OTHER_GOV |
| Maccabi Healthcare Services, Israel | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observation group | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 2 years from patient first enrollment |
| Skin reactions differences | skin assessment at the pump insertion site (itching and redness). | 2 years from patient first enrollment |
| Discontinuation rate differences | Comparison between constant pump users and those who discontinued | 2 years from patient first enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 years from patient first enrollment |
| Glycemic control and metabolic parameters differences: HbA1c% |
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Inclusion Criteria:
Exclusion Criteria:
• No restrictions on HbA1c value at study recruitment or on use of CGMS -
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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).
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The difference in HbA1c% as measured by each center ll local lab. |
| 2 years from patient first enrollment |
| Glycemic control and metabolic parameters differences:Glucose Mean & SD | Glucose Mean & SD as recorded by SMBG | 2 years from patient first enrollment |
| Glycemic control and metabolic parameters differences:Number of SMBG per day | Data derived from data recorded by SMBG | 2 years from patient first enrollment |
| Glycemic control and metabolic parameters differences:BMI SDS | according to Center for Disease Control (CDC) growth charts scale | 2 years from patient first enrollment |