The Impact of Different CSII and CGM Systems on Different Clinical Outcome Variables in Children and Adolescents With Type 1 Diabetes. An Observational Study Form the Norwegian Childhood Diabetes Registry (NCDR)

Study Overview
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Brief Summary
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To examine the effect of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) on metabolic control, in a large population-based nationwide observational study under real life conditions. All children and adolescents with type 1 diabetes are investigated,using annual data in 2017 from the population-based Norwegian Childhood Diabetes Registry (NCDR). HbA1c, incidence of diabetes ketoacidosis (DKA) and severe hypoglycemia (SH) are evaluated depending on the use of CSII and CGM in a linear mixed-effects and linear regression model adjusted for age, biologic gender and diabetes duration. Health-related quality of Life (HRQOL) is assessed by using the DISABKIDS diabetes specific module (DDM-10), and associations with the use of CSII, CGM, age, gender and diabetes duration are evaluated.

Detailed Description
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In Norway, all children with diabetes 0-18 years should, due to a recommendation from the national health care authority, receive their diabetes follow-up in a pediatric department. All pediatric departments participate in the NCDR reporting standardized clinical data on their patients to the NCDR, at diabetes onset and annually, until the patients reach 18 years of age. The data completeness of NCDR is high, on individual level 99 % at diabetes onset, and 98 % on the annual examinations in 2016 - 2017. In addition, HRQOL data were collected in 2017, using the DISABKIDS diabetes specific module (DDM-10). Children 10-17 years with type 1 diabetes were invited to independently fill out the questionnaire regarding their own disease-related quality of life. All parents to children with type 1 diabetes (independent of the child's age) were invited to fill out the same questionnaire, giving a proxy evaluation of their child's quality of life.

Official Title
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The Impact of Different CSII and CGM Systems on Metabolic Control and Quality of Life in Children and Adolescents With Type 1 Diabetes. An Observational Study Form the Norwegian Childhood Diabetes Registry (NCDR)

Conditions
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Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: CSII and CGM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All registered subjects with type 1 diabetes in the 2017 annual cohort of the NCDR Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CSII and CGM|use of CSII as insulin delivery or CGM as glucose monitoring|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | measured at annual follow-up in 2017 | 
| DKA | diabetic ketoacidosis leading to hospitalization | registered at annual follow-up in 2017 | 
| SH | Severe hypoglycemia | registered at annual follow-up in 2017 | 
| HRQOL | health-related quality of life measured with the DISABKIDS diabetes module DDM-10 | participation connected to annual follow-up in 2017 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T1D, CSII, CGM, diabetic ketoacidosis, hypoglycemia, HRQOL