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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04558710
• Other study ID #: VibRate Study
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: December 30, 2019

Study information

• Verified date: September 2020
• Source: University of Ljubljana, Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: December 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Children
• Continuous Glucose Monitoring
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Glucose Variability
• Type 1 Diabetes

Locations

Country	Name	City	State
Slovenia	Medical Faculty - University of Ljubljana	Ljubljana

Sponsors (14)

Lead Sponsor

Collaborator

University of Ljubljana, Faculty of Medicine

Department of Pediatrcs, Endocrinology and Diabetes Medical University of Silesia in Katowice, Poland, Department of Pediatric Endocrinology and Diabetes, Koç University Hospital, Istanbul, Turkey., Department of Pediatrics, San Raffaele Scientific Institute , Milan, Italy, Department of Pediatrics, Sapienza University of Rome, Rome, 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, Yale University School of Medicine, Department of Pediatrics, New Haven, Connecticut, United States

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coefficient of variation		1 year
Secondary	Time in Range	Time in Range 70 - 180 mg/dl	1 year
Secondary	Time Above Range	Time in Range above 180 mg/dl	1 year