Preschool CGM Use and Glucose Variability in Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-30

Study Completion Date

2017-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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CGM ON

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

Intervention Type DEVICE

CGM OFF

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

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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UMC - University Children's Hospital Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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CGM-GV-Preschool- SI-01

Identifier Type: -

Identifier Source: org_study_id