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)

Sponsor

Helse Fonna (Other)

Overall Status

Completed

CT.gov ID

NCT04201171

Collaborator

Oslo University Hospital (Other), Helse Vest (Other), University of Bergen (Other), Haukeland University Hospital (Other)

2,749

Enrollment

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 1	Device: CSII and CGM

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.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

2749 participants

Observational Model:

Cohort

Time Perspective:

Other

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)

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Dec 31, 2017

Outcome Measures

Primary Outcome Measures

HbA1c [measured at annual follow-up in 2017]
DKA [registered at annual follow-up in 2017]
diabetic ketoacidosis leading to hospitalization
SH [registered at annual follow-up in 2017]
Severe hypoglycemia
HRQOL [participation connected to annual follow-up in 2017]
health-related quality of life measured with the DISABKIDS diabetes module DDM-10

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years to 18 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Helse Fonna
Oslo University Hospital
Helse Vest
University of Bergen
Haukeland University Hospital

Investigators

Principal Investigator: Heiko Bratke, MD, Haugesund Hospital, Fonna Health Trust, Norway

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Helse Fonna

ClinicalTrials.gov Identifier:

NCT04201171

Other Study ID Numbers:

2016/1613

First Posted:

Dec 17, 2019

Last Update Posted:

Oct 6, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Helse Fonna

T1D

CSII

CGM

diabetic ketoacidosis

hypoglycemia

HRQOL

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Oct 6, 2021