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Completed

NCT Number: NCT04558710

The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes

The purpose of this study is to determine whether continuous glucose monitoring will improve glucose variability as measured by the coefficient of variation of glucose levels in very young children with T1D. The study adopts an open-label, multi-centre, multinational, prospective registry-based population cohort design contrasting CGM use to SMBG alone in young children with type 1 diabetes over 12 months.

The primary endpoint is the difference between treatment modalities (CGM vs SMBG alone) in glycaemic variability, measured as the coefficient of variation of glucose levels, during the 12 months observational period. Other Key edpoints include time in range 70-180 mg/dl, time below range 70 mg/dl and time above range 180 mg/dl.

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Key information

Conditions

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

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Faculty - University of Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

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

Key inclusion criteria:

  • Age below 7 years of age (at inclusion)
  • Type 1 diabetes for at least 6 months
  • Insulin pump user for at least 3 months
  • Treated with rapid or ultra-rapid acting insulin analogue

Key exclusion criteria:

  • Physical or psychological disease likely to interfere with normal conduct of the study
  • Untreated coeliac disease or thyroid disease
  • Current treatment with drugs known to interfere with glucose metabolism
  • Subject/carer's severe visual impairment
  • Subject/carer's severe hearing impairment

Treatment and study plan

Primary outcomes

  1. Coefficient of variation

    Time frame: 1 year

Secondary outcomes

  1. Time in Range

    Time frame: 1 year

    Time in Range 70 - 180 mg/dl

  2. Time Above Range

    Time frame: 1 year

    Time in Range above 180 mg/dl

Sponsors and collaborators

Lead sponsor

University of Ljubljana, Faculty of Medicine

Other

Collaborators

  • Department of Pediatrcs, Endocrinology and Diabetes Medical University of Silesia in Katowice, Poland
  • Department of Pediatric Endocrinology and Diabetes, Koç University Hospital, İstanbul, Turkey.
  • Department of Pediatrics, San Raffaele Scientific Institute , Milan, Italy
  • Department of Pediatrics, Section on Diabetes and Metabolism, V. Buzzi Children's Hospital, University of Milan, Milan, Italy
  • Diaboss, Amsterdam, Netherlands
  • International Society for Pediatric and Adolescent Diabetes
  • Kinderkrankenhaus auf der Bult, Hannover, Germany
  • Medical School, University of Valparaiso, San Felipe, Chile.
  • Pediatric Diabetes and Metabolic Disorders Unit, Regional Center for Pediatric Diabetes, University City Hospital of Verona, Verona, Italy
  • Pediatric Endocrinology Unit, Paediatrics Department, Maternal and Paediatrics Centre, São João University and Hospital Centre, Porto, Porto, Portugal
  • Pediatric Endocrinology Unit. Hospital Pediátrico. Centro Hospitalar e Universitário de Coimbra. Coimbra. Portugal
  • University of Roma La Sapienza
  • Yale University

Registry information

Official study title

The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes - The VibRate Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2020
Registry last updated
May 10, 2023

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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