Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps

Study Overview
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Brief Summary
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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.

Official Title
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Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps

Conditions
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T1DM

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of T1D recorded by a pediatric endocrinologist Attending periodic clinic visits, and starting pump mode of therapy between May 2015 and March 2017. Exclusion Criteria: • No restrictions on HbA1c value at study recruitment or on use of CGMS -

Ages Eligible for Study
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Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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% | 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 |