- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04558710
The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes
The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes - The VibRate Study
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Ljubljana, Slovenia, 1000
- Medical Faculty - University of Ljubljana
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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CGM
CGM users
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SMBG
Non-CGM users
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Coefficient of variation
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time in Range
Time Frame: 1 year
|
Time in Range 70 - 180 mg/dl
|
1 year
|
Time Above Range
Time Frame: 1 year
|
Time in Range above 180 mg/dl
|
1 year
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VibRate Study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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