Children, Continuous Glucose Monitoring, Glucose Variability, Type 1 Diabetes
Conditions
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.
Interventions
None listed
Sponsors
International Society for Pediatric and Adolescent Diabetes
Kinderkrankenhaus auf der Bult, Hannover, Germany
Department of Pediatrcs, Endocrinology and Diabetes Medical University of Silesia in Katowice, Poland
Pediatric Diabetes and Metabolic Disorders Unit, Regional Center for Pediatric Diabetes, University City Hospital of Verona, Verona, Italy
Yale University School of Medicine, Department of Pediatrics, New Haven, Connecticut, United States
Pediatric Endocrinology Unit, Paediatrics Department, Maternal and Paediatrics Centre, São João University and Hospital Centre, Porto, Porto, Portugal
Department of Pediatrics, Section on Diabetes and Metabolism, V. Buzzi Children's Hospital, University of Milan, Milan, Italy
Pediatric Endocrinology Unit. Hospital Pediátrico. Centro Hospitalar e Universitário de Coimbra. Coimbra. Portugal
Diaboss, Amsterdam, Netherlands
Medical School, University of Valparaiso, San Felipe, Chile.
Department of Pediatric Endocrinology and Diabetes, Koç University Hospital, İstanbul, Turkey.
University of Roma La Sapienza
Department of Pediatrics, San Raffaele Scientific Institute , Milan, Italy
University of Ljubljana, Faculty of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Coefficient of variation | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range | 1 year | Time in Range 70 - 180 mg/dl |
| Time Above Range | 1 year | Time in Range above 180 mg/dl |
Countries
Slovenia
Outcome results
None listed