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

• Conditions: Type 1 Diabetes
• Interventions: Other: functional insulinotherapy class

• Registration Number: NCT00973492
• Lead Sponsor: Association Grenobloise pour le Developpement D'etudes et de Recherches en Physiopathologie Endocrinienne, Diabetologie et Maladies de la Nutrition

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.

Study Timeline

• Study Start: 2007-09
• Status Verified: 2009-09
• Study First Submitted: 2009-09-07
• Study First Submitted QC: 2009-09-08
• Last Update Submitted: 2009-09-08
• Study First Posted: 2009-09-09
• Last Update Posted: 2009-09-09
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with functional insulinotherapy	functional insulinotherapy class	There is only one group in this study. The participants will attend a functional insulinotherapy class.

Primary Outcome Measures

Name	Time	Method
MAGE, ADRR, Lability Index and LBGI computed with the blood glucose measurement or CGMS	0, 3 months, 6 months

Secondary Outcome Measures

Name	Time	Method
anti-transglutaminase and anti-endomysium antibodies	0 months, 6 months
dosage of urinary leucotriene E4 and 11-dehydro-thromboxane B2, 8-iso-PGF2alpha	0 months, 6 months
anti-insulin antibodies by ELISA	0 months

Trial Locations

Locations (1)

Service de Diabétologie du Pr Halimi, CHU; 🇫🇷 Grenoble Cedex 9, France