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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)

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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04201171
Enrollment
2749
Registered
2019-12-17
Start date
2017-01-01
Completion date
2017-12-31
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

T1D, CSII, CGM, diabetic ketoacidosis, hypoglycemia, HRQOL

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.

Interventions

DEVICECSII and CGM

use of CSII as insulin delivery or CGM as glucose monitoring

Sponsors

Oslo University Hospital
CollaboratorOTHER
Helse Vest
CollaboratorOTHER
University of Bergen
CollaboratorOTHER
Haukeland University Hospital
CollaboratorOTHER
Helse Fonna
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years

Inclusion criteria

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

Exclusion criteria

None

Design outcomes

Primary

MeasureTime frameDescription
HbA1cmeasured at annual follow-up in 2017
DKAregistered at annual follow-up in 2017diabetic ketoacidosis leading to hospitalization
SHregistered at annual follow-up in 2017Severe hypoglycemia
HRQOLparticipation connected to annual follow-up in 2017health-related quality of life measured with the DISABKIDS diabetes module DDM-10

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026