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

Study Type

Observational

Enrollment (Actual)

339

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Ljubljana, Slovenia, 1000
        • Medical Faculty - University of Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 7 years (Child)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
CGM
CGM users
SMBG
Non-CGM users

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

September 16, 2020

First Posted (Actual)

September 22, 2020

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 9, 2023

Last Verified

September 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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