Type 1 Diabetes Clinical Trial
Official title:
Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes
The primary objective of this trial is to assess whether functional insulinotherapy
decreases blood glucose variability at 3 months and 6 months, compared to initial values in
type 1 diabetes patients.
So, this study measures the impact of functional insulinotherapy on several blood glucose
variability indicators in patients with type 1 diabetes.
This trial also has a secondary objective: to measure the effect of functional
insulinotherapy on oxidative stress and inflammation.
This is a prospective, open, non-controlled study with an individual benefit for the
participant. This study is designed to assess whether functional insulinotherapy decreases
blood glucose variability at 3 months and 6 months, compared to initial values in type 1
diabetes patients.
All 30 patients with type 1 diabetes attended a 4-day functional insulinotherapy class,
taught by 2 nurses, 2 dieticians and 2 physicians. The participants were recruited among
metabolically stable patients who had already been prescribed functional insulinotherapy.
To assess the impact of functional insulinotherapy on blood glucose variability, HbA1c will
be measured at 0, 3 months and 6 months along with 4 blood glucose variability indicators:
MAGE, ADRR, LI and LBGI.
This trial also has a secondary objective: to measure the effect of functional
insulinotherapy on oxidative stress. Therefore, a measure of insulin antibodies by ELISA at
baseline. At baseline and 6 months, LTE4, TXB2, 8-iso-PGF2alpha, anti-transglutaminase and
anti-endomysium antibodies will also be assessed.
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Observational Model: Case-Only, Time Perspective: Prospective
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