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

Type 1 Diabetes Clinical Trial

— VARIAFIT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00973492
• Other study ID #: 2007-A00903-50
• Status: Active, not recruiting
• Phase: N/A
• First received: September 7, 2009
• Last updated: September 8, 2009
• Start date: September 2007
• Est. completion date: December 2009

Study information

• Verified date: September 2009
• Source: Association Grenobloise pour le Developpement D'etudes et de Recherches en Physiopathologie Endocrinienne, Diabetologie et Maladies de la Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• functional insulinotherapy class
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.

Locations

Country	Name	City	State
France	Service de Diabétologie du Pr Halimi, CHU	Grenoble Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Association Grenobloise pour le Developpement D'etudes et de Recherches en Physiopathologie Endocrinienne, Diabetologie et Maladies de la Nutrition

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MAGE, ADRR, Lability Index and LBGI computed with the blood glucose measurement or CGMS		0, 3 months, 6 months	No
Secondary	anti-transglutaminase and anti-endomysium antibodies		0 months, 6 months	No
Secondary	dosage of urinary leucotriene E4 and 11-dehydro-thromboxane B2, 8-iso-PGF2alpha		0 months, 6 months	No
Secondary	anti-insulin antibodies by ELISA		0 months	No