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

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.

Conditions

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

Sponsors & Collaborators

• International Society for Pediatric and Adolescent Diabetes

  collaborator UNKNOWN

• Kinderkrankenhaus auf der Bult, Hannover, Germany

  collaborator UNKNOWN

• Department of Pediatrcs, Endocrinology and Diabetes Medical University of Silesia in Katowice, Poland

  collaborator UNKNOWN

• Pediatric Diabetes and Metabolic Disorders Unit, Regional Center for Pediatric Diabetes, University City Hospital of Verona, Verona, Italy

  collaborator UNKNOWN

• Yale University School of Medicine, Department of Pediatrics, New Haven, Connecticut, United States

  collaborator UNKNOWN

• Pediatric Endocrinology Unit, Paediatrics Department, Maternal and Paediatrics Centre, São João University and Hospital Centre, Porto, Porto, Portugal

  collaborator UNKNOWN

• Department of Pediatrics, Section on Diabetes and Metabolism, V. Buzzi Children's Hospital, University of Milan, Milan, Italy

  collaborator UNKNOWN

• Pediatric Endocrinology Unit. Hospital Pediátrico. Centro Hospitalar e Universitário de Coimbra. Coimbra. Portugal

  collaborator UNKNOWN

• Diaboss, Amsterdam, Netherlands

  collaborator UNKNOWN

• Medical School, University of Valparaiso, San Felipe, Chile.

  collaborator UNKNOWN

• Department of Pediatric Endocrinology and Diabetes, Koç University Hospital, İstanbul, Turkey.

  collaborator UNKNOWN

• University of Roma La Sapienza

  collaborator OTHER

• Department of Pediatrics, San Raffaele Scientific Institute , Milan, Italy

  collaborator UNKNOWN

• University of Ljubljana, Faculty of Medicine

  lead OTHER

Eligibility

Min Age

1 Year

Max Age

7 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-01

Primary Completion

2019-09-30

Completion

2019-12-30

Countries

• Slovenia

Study Locations