Clinical trial NCT00973492: Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes
Official title: Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
functional insulinotherapy
Lead sponsor: Association Grenobloise pour le Developpement D'etudes et de Recherches en Physiopathologie Endocrinienne, Diabetologie et Maladies de la Nutrition
Sponsor class: OTHER
First posted: 2009-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have been prescribed functional insulinotherapy at University Hospital Grenoble

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: MAGE, ADRR, Lability Index and LBGI computed with the blood glucose measurement or CGMS
timeFrame: 0, 3 months, 6 months
Secondary outcomes:
measure: anti-transglutaminase and anti-endomysium antibodies
timeFrame: 0 months, 6 months
measure: dosage of urinary leucotriene E4 and 11-dehydro-thromboxane B2, 8-iso-PGF2alpha
timeFrame: 0 months, 6 months
measure: anti-insulin antibodies by ELISA
timeFrame: 0 months
Other outcomes:
Locations:
city: Grenoble Cedex 9
country: France
facility: Service de Diabétologie du Pr Halimi, CHU
Study officials:
affiliation: University Hospital, Grenoble
name: Pierre-Yves Benhamou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benhamou PY, Somers F, Lablanche S, Debaty I, Borel AL, Nasse L, Stanke-Labesque F, Faure P, Boizel R, Halimi S. Impact of flexible insulin therapy on blood glucose variability, oxidative stress and inflammation in type 1 diabetic patients: the VARIAFIT study. Diabetes Metab. 2014 Sep;40(4):278-83. doi: 10.1016/j.diabet.2014.01.004. Epub 2014 Feb 24.