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JENIOUS Research Projects - Call for Applications
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Call for Applications - June 2018

The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes
– The VibRate study

 

Final version 3. Jan. 2018, after JENIOUS discussion meeting in Innsbruck on October 22, 2017

Background:

Glucose variability (GV) is potentially associated with damage to the developing brain in children with type 1 diabetes (T1D). Regular continuous glucose monitoring (CGM) use reduces GV in older children. The evidence on CGM efficacy in preschool children is limited and inconsistent. The objective of this study is to evaluate the efficacy of CGM on GV in preschoolers with T1D.

Research Questions:
To evaluate the effect of CGM use on glucose variability (primary endpoint) and other metrics of glycemic control (secondary endpoint) in population of children with type 1 diabetes below 7 years on CSII therapy (for at least 6 months).

Primary contact person

Klemen Dovc: klemen.dovc@kclj.si

 

Study details (eligibility criteria, center information (no. of patients, HCPs, ), template spreadsheet, etc.) will be send subsequently.

 

Requirements for participation of countries:
Center data available for whole observational period (1 year, expected July 2018 – June 2019)
No obvious selection bias
Willingness to share patient-level data for joint analysis

 

Required Data per Patient (T1D only)
Gender (M / F)
Body weight, body height
Race/ethnicity
Date of birth
Date of T1D onset
Date of CSII therapy onset
CSII model
Date of CGM onset
CGM model
C-peptide (if applicable)

For each visit:
HbA1c
Sensor and Pump downloads (saved preferably as CSV/XLS or TXT format; eventually as PDF)
TDD
Basal/Bolus ratio
Mean (SD) Blood Glucose
Mean (SD) Sensor Glucose
DKA/Severe hypoglycemia events

Timeline
Commitment to participate until 30. June 2018
Study end June 2019 
Preliminary statistical analysis until September 2019
First draft of manuscript end of 2019

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