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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)

NCT04201171 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2749

Last updated 2021-10-06

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

CSII and CGM

use of CSII as insulin delivery or CGM as glucose monitoring

Sponsors & Collaborators

  • Oslo University Hospital

    collaborator OTHER

  • Helse Vest

    collaborator OTHER

  • University of Bergen

    collaborator OTHER

  • Haukeland University Hospital

    collaborator OTHER

  • Helse Fonna

    lead OTHER

Principal Investigators

  • Heiko Bratke, MD · Haugesund Hospital, Fonna Health Trust, Norway

Eligibility

Min Age
0 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2017-12-31
Completion
2017-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04201171 on ClinicalTrials.gov