Clinical trial NCT04558710: The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes
Official title: The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes - The VibRate Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Continuous Glucose Monitoring
Children
Glucose Variability
Lead sponsor: University of Ljubljana, Faculty of Medicine
Sponsor class: OTHER
Collaborators: name: International Society for Pediatric and Adolescent Diabetes
name: Kinderkrankenhaus auf der Bult, Hannover, Germany
name: Department of Pediatrcs, Endocrinology and Diabetes Medical University of Silesia in Katowice, Poland
name: Pediatric Diabetes and Metabolic Disorders Unit, Regional Center for Pediatric Diabetes, University City Hospital of Verona, Verona, Italy
name: Yale University School of Medicine, Department of Pediatrics, New Haven, Connecticut, United States
name: Pediatric Endocrinology Unit, Paediatrics Department, Maternal and Paediatrics Centre, São João University and Hospital Centre, Porto, Porto, Portugal
name: Department of Pediatrics, Section on Diabetes and Metabolism, V. Buzzi Children's Hospital, University of Milan, Milan, Italy
name: Pediatric Endocrinology Unit. Hospital Pediátrico. Centro Hospitalar e Universitário de Coimbra. Coimbra. Portugal
name: Diaboss, Amsterdam, Netherlands
name: Medical School, University of Valparaiso, San Felipe, Chile.
name: Department of Pediatric Endocrinology and Diabetes, Koç University Hospital, İstanbul, Turkey.
name: University of Roma La Sapienza
name: Department of Pediatrics, San Raffaele Scientific Institute , Milan, Italy
First posted: 2020-09-22
Enrollment: 339
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pre-school children below age of 7 years with type 1 diabetes (for at least 6 months) and treated with insulin pump fo at least 3 months.

Brief summary: 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.


Eligibility criteria: Key inclusion criteria:

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

Key exclusion criteria:

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

Primary outcomes:
measure: Coefficient of variation
timeFrame: 1 year
Secondary outcomes:
measure: Time in Range
timeFrame: 1 year
measure: Time Above Range
timeFrame: 1 year
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Medical Faculty - University of Ljubljana
Study officials:
References: