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Preschool CGM Use and Glucose Variability in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03293082
Recruitment Status : Completed
First Posted : September 26, 2017
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
University of Ljubljana, Faculty of Medicine

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).


Condition or disease Intervention/treatment
Type 1 Diabetes Mellitus Device: CGM ON Device: CGM OFF

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Study Type : Observational [Patient Registry]
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Years
Official Title: The Effect of Continuous Glucose Monitoring Use on Glucose Variability in Preschool Children With Type 1 Diabetes
Actual Study Start Date : September 30, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: CGM ON
    The period of time when continuous glucose monitoring was used, in edition to SMBG
  • Device: CGM OFF
    The period of time when continuous glucose monitoring was not used, only SMBG


Primary Outcome Measures :
  1. Glucose variability [ Time Frame: Three years ]
    Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose


Secondary Outcome Measures :
  1. Mean intersticial glucose [ Time Frame: Three years ]
    Mean glucose as measured with CGM

  2. Mean blood glucose [ Time Frame: Three years ]
    Mean glucose as measured with SMBG

  3. HbA1c [ Time Frame: Three years ]
    glycosilated hemoglobin



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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes 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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03293082


Locations
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Slovenia
UMC - University Children's Hospital Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University of Ljubljana, Faculty of Medicine
Additional Information:

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Responsible Party: University of Ljubljana, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT03293082    
Other Study ID Numbers: CGM-GV-Preschool- SI-01
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases