Preschool CGM Use and Glucose Variability in Type 1 Diabetes

October 2, 2017 updated by: University of Ljubljana, Faculty of Medicine

The Effect of Continuous Glucose Monitoring Use on Glucose Variability in Preschool Children With Type 1 Diabetes

The objectives of this clinical study is to evaluate the efficacy continuous glucose monitoring (CGM) use on glucose variability (GV) in preschool children with T1D treated with CSII.

Downloads from CGM and CSII saved in pdf from will be retrospectively reviewed and analysed for all preschool children with type 1 diabetes in Slovenia. Glucose variability and other glycemic parameters will be analyzed separately for periods when CGM was used (CGM and SMBG data) and compared to periods when CGM was not used (SMBG only data).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

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

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • UMC - University Children's Hospital 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 5 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Population of preschool children with type 1 diabetes aged up to 7 years that were prescribed sensor use in the observational period.

Description

Inclusion Criteria:

  1. Subject with Type 1 diabetes (> 6 months since diagnosis)
  2. Insulin infusion pump CSII therapy for at least 3 months
  3. Age ≤ 7 years
  4. HbA1c at inclusion ≥ 6.5 and < 10
  5. BMI SDS - below the 95th percentile for age

Exclusion Criteria:

  1. Concomitant diseases that influence metabolic control
  2. Participation in any other interventional study
  3. Known or suspected allergy to trial products

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose variability
Time Frame: Three years
Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose
Three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean intersticial glucose
Time Frame: Three years
Mean glucose as measured with CGM
Three years
Mean blood glucose
Time Frame: Three years
Mean glucose as measured with SMBG
Three years
HbA1c
Time Frame: Three years
glycosilated hemoglobin
Three years

Collaborators and Investigators

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

Sponsor

University of Ljubljana, Faculty of Medicine

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)

September 30, 2017

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

September 30, 2017

Study Registration Dates

First Submitted

September 21, 2017

First Submitted That Met QC Criteria

September 21, 2017

First Posted (Actual)

September 26, 2017

Study Record Updates

Last Update Posted (Actual)

October 3, 2017

Last Update Submitted That Met QC Criteria

October 2, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGM-GV-Preschool- SI-01

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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