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Completed

NCT Number: NCT03293082

Preschool CGM Use and Glucose Variability in Type 1 Diabetes

The objectives of this clinical study is to evaluate the efficacy continuous glucose monitoring (CGM) use on glucose variability (GV) in preschool children with T1D treated with CSII.

Downloads from CGM and CSII saved in pdf from will be retrospectively reviewed and analysed for all preschool children with type 1 diabetes in Slovenia. Glucose variability and other glycemic parameters will be analyzed separately for periods when CGM was used (CGM and SMBG data) and compared to periods when CGM was not used (SMBG only data).

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

Up to 7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UMC - University Children's Hospital Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

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

Inclusion criteria

  • Subject with Type 1 diabetes (> 6 months since diagnosis)
  • Insulin infusion pump CSII therapy for at least 3 months
  • Age ≤ 7 years
  • HbA1c at inclusion ≥ 6.5 and < 10
  • BMI SDS - below the 95th percentile for age

Exclusion criteria

  • Concomitant diseases that influence metabolic control
  • Participation in any other interventional study
  • Known or suspected allergy to trial products

Treatment and study plan

CGM ON

Device

The period of time when continuous glucose monitoring was used, in edition to SMBG

CGM OFF

Device

The period of time when continuous glucose monitoring was not used, only SMBG

Primary outcomes

  1. Glucose variability

    Time frame: Three years

    Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose

Secondary outcomes

  1. Mean intersticial glucose

    Time frame: Three years

    Mean glucose as measured with CGM

  2. Mean blood glucose

    Time frame: Three years

    Mean glucose as measured with SMBG

  3. HbA1c

    Time frame: Three years

    glycosilated hemoglobin

Sponsors and collaborators

Lead sponsor

University of Ljubljana, Faculty of Medicine

Other

Registry information

Official study title

The Effect of Continuous Glucose Monitoring Use on Glucose Variability in Preschool Children With Type 1 Diabetes

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 26, 2017
Registry last updated
Oct 3, 2017

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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