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)

Diabetes Mellitus, Type 1 Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04201171
• Other study ID #: 2016/1613
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: September 2021
• Source: Helse Fonna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2749
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• CSII and CGM
use of CSII as insulin delivery or CGM as glucose monitoring

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Helse Fonna	Haukeland University Hospital, Helse Vest, Oslo University Hospital, University of Bergen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		measured at annual follow-up in 2017
Primary	DKA	diabetic ketoacidosis leading to hospitalization	registered at annual follow-up in 2017
Primary	SH	Severe hypoglycemia	registered at annual follow-up in 2017
Primary	HRQOL	health-related quality of life measured with the DISABKIDS diabetes module DDM-10	participation connected to annual follow-up in 2017