Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes

N/AUnknownNCT00973492

Association Grenobloise pour le Developpement D'etudes et de Recherches en Physiopathologie Endocrinienne, Diabetologie et Maladies de la Nutrition30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 1 Diabetes

Interventions

The functional insulinotherapy class lasts for 4 days. It is taught by 2 nurses, 2 dieticians and 2 physicians to 6 to 10 patients. On day 1, patients describe their difficulties with diabetes. Fast-acting insulin scales are elaborated from preprandial and postprandial blood glucose levels. At dinner, patients start a 24-hour glucose-fasting period to evaluate their need for basal insulin. Meals contain virtually no carbohydrates. Correcting doses of insulin are administered if preprandial glycemia is over 1.50 g/l or postprandial glycemia is over 2 g/l. Blood glucose levels must stay within normal values during the whole 24-hour period. Carbohydrate management is taught during meals and every afternoon through workshops about dietetics. Patients also learn how to deal with hypoglycaemia, hyperglycaemia and physical activity. A one-day follow-up takes place 3 months later.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

MAGE, ADRR, Lability Index and LBGI computed with the blood glucose measurement or CGMS

Time frame: 0, 3 months, 6 months

Secondary Outcomes

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