Clinical trial NCT04201171: 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)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Keywords: T1D
CSII
CGM
diabetic ketoacidosis
hypoglycemia
HRQOL
Lead sponsor: Helse Fonna
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Helse Vest
name: University of Bergen
name: Haukeland University Hospital
First posted: 2019-12-17
Enrollment: 2749
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our cohort consists of 2749 patients with type 1 diabetes, 45.5 % females; mean age was 12.9 years (SD 3.9, min 1.7, max 20.2) and mean diabetes duration was 5.3 years (SD 3.7)

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

All registered subjects with type 1 diabetes in the 2017 annual cohort of the NCDR

Exclusion Criteria:

None

Primary outcomes:
measure: HbA1c
timeFrame: measured at annual follow-up in 2017
measure: DKA
timeFrame: registered at annual follow-up in 2017
measure: SH
timeFrame: registered at annual follow-up in 2017
measure: HRQOL
timeFrame: participation connected to annual follow-up in 2017
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Haugesund Hospital, Fonna Health Trust, Norway
name: Heiko Bratke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bratke H, Margeirsdottir HD, Assmus J, Njolstad PR, Skrivarhaug T. Does Current Diabetes Technology Improve Metabolic Control? A Cross-Sectional Study on the Use of Insulin Pumps and Continuous Glucose Monitoring Devices in a Nationwide Pediatric Population. Diabetes Ther. 2021 Sep;12(9):2571-2583. doi: 10.1007/s13300-021-01127-6. Epub 2021 Aug 13.