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NCT Number: NCT04201171

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)

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Acid-Base Imbalance Acidosis Autoimmune Diseases Diabetes Complications Diabetes Mellitus Diabetic Ketoacidosis Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Ketosis Metabolic Diseases Nutritional and Metabolic Diseases

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

CSII and CGM

Device

use of CSII as insulin delivery or CGM as glucose monitoring

Primary outcomes

  1. HbA1c

    Time frame: measured at annual follow-up in 2017

  2. DKA

    Time frame: registered at annual follow-up in 2017

    diabetic ketoacidosis leading to hospitalization

  3. SH

    Time frame: registered at annual follow-up in 2017

    Severe hypoglycemia

  4. HRQOL

    Time frame: participation connected to annual follow-up in 2017

    health-related quality of life measured with the DISABKIDS diabetes module DDM-10

Sponsors and collaborators

Lead sponsor

Helse Fonna

Other

Collaborators

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

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 17, 2019
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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