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)

NCT ID: NCT04201171

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2749 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2017-12-31

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

CSII and CGM

use of CSII as insulin delivery or CGM as glucose monitoring

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

None

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: collaborator

Helse Vest

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

Helse Fonna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heiko Bratke, MD

Role: PRINCIPAL_INVESTIGATOR

Haugesund Hospital, Fonna Health Trust, Norway

References

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.

Reference Type: DERIVED

PMID: 34389930 (View on PubMed)

Other Identifiers

2016/1613

Identifier Type: -

Identifier Source: org_study_id