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 | Completed FDA Device

• 1 other identifier: 2016/1613
• Study Type: observational
• Target: 2,749
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

T1D; CSII; CGM; diabetic ketoacidosis; hypoglycemia; HRQOL

Outcome Measures

Primary Outcomes (4)

• 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

Interventions

CSII and CGM DEVICE

use of CSII as insulin delivery or CGM as glucose monitoring

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Helse Fonna: lead
• Oslo University Hospital: collaborator
• Helse Vest: collaborator
• University of Bergen: collaborator
• Haukeland University Hospital: collaborator

Related Publications (1)

• 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.

  PMID: 34389930 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetic Ketoacidosis; Hypoglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Ketosis; Acidosis; Acid-Base Imbalance; Diabetes Complications

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Heiko Bratke, MD

  Haugesund Hospital, Fonna Health Trust, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 17, 2019
• Study Start: January 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: October 6, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share