NCT03293082

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

September 30, 2017

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2017

Completed
Last Updated

October 3, 2017

Status Verified

September 1, 2017

Enrollment Period

Same day

First QC Date

September 21, 2017

Last Update Submit

October 2, 2017

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Glucose variability

    Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose

    Three years

Secondary Outcomes (3)

  • Mean intersticial glucose

    Three years

  • Mean blood glucose

    Three years

  • HbA1c

    Three years

Interventions

CGM ONDEVICE

The period of time when continuous glucose monitoring was used, in edition to SMBG

CGM OFFDEVICE

The period of time when continuous glucose monitoring was not used, only SMBG

Eligibility Criteria

AgeUp to 7 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Subject with Type 1 diabetes (\> 6 months since diagnosis)
  • Insulin infusion pump CSII therapy for at least 3 months
  • Age ≤ 7 years
  • BMI SDS - below the 95th percentile for age

You may not qualify if:

  • Concomitant diseases that influence metabolic control
  • Participation in any other interventional study
  • Known or suspected allergy to trial products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC - University Children's Hospital Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2017

First Posted

September 26, 2017

Study Start

September 30, 2017

Primary Completion

September 30, 2017

Study Completion

September 30, 2017

Last Updated

October 3, 2017

Record last verified: 2017-09

Locations

SL(1)