Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes
This trial is active, not recruiting.
|Condition||type 1 diabetes|
|Treatment||functional insulinotherapy class|
|Sponsor||Association Grenobloise pour le Developpement D'etudes et de Recherches en Physiopathologie Endocrinienne, Diabetologie et Maladies de la Nutrition|
|Start date||September 2007|
|End date||December 2009|
|Trial size||30 participants|
|Trial identifier||NCT00973492, 2007-A00903-50|
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.
MAGE, ADRR, Lability Index and LBGI computed with the blood glucose measurement or CGMS
time frame: 0, 3 months, 6 months
anti-transglutaminase and anti-endomysium antibodies
time frame: 0 months, 6 months
dosage of urinary leucotriene E4 and 11-dehydro-thromboxane B2, 8-iso-PGF2alpha
time frame: 0 months, 6 months
anti-insulin antibodies by ELISA
time frame: 0 months
Male or female participants at least 18 years old.
Inclusion Criteria: - Patients with type 1 diabetes with pump or multi-injection treatment and attending a functional insulinotherapy class - Social Security membership or benefit from Social Security - Informed consent, with a signed and approved form Exclusion Criteria: - Underage patient, major patient under guardianship or protected by the Law - Pregnant, parturient or breastfeeding woman - Person with no freedom (prisoner), person in an emergency situation, person hospitalized without consent and not protected by the Law - Antecedents of pathologies causing diabetes instability (coeliac disease, gastroparesis, non-balanced psychiatric pathology) and not optimally treated, acute pathology less than 3 months ago (infectious, cardio-vascular, metabolic), pregnancy
|Official title||Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes|
|Principal investigator||Pierre-Yves Benhamou, PhD|
|Description||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.|
Call for more information