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

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Type 1 Diabetes	Other: functional insulinotherapy class

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 Design

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Study Type :	Observational
Actual Enrollment :	30 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes
Study Start Date :	September 2007
Estimated Primary Completion Date :	December 2009
Estimated Study Completion Date :	December 2009

Groups and Cohorts

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Group/Cohort

Intervention/treatment

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

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.

Outcome Measures

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Primary Outcome Measures :

1. MAGE, ADRR, Lability Index and LBGI computed with the blood glucose measurement or CGMS [ Time Frame: 0, 3 months, 6 months ]

Secondary Outcome Measures :

1. anti-transglutaminase and anti-endomysium antibodies [ Time Frame: 0 months, 6 months ]
2. dosage of urinary leucotriene E4 and 11-dehydro-thromboxane B2, 8-iso-PGF2alpha [ Time Frame: 0 months, 6 months ]
3. anti-insulin antibodies by ELISA [ Time Frame: 0 months ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients that have been prescribed functional insulinotherapy at University Hospital Grenoble

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

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

France
Service de Diabétologie du Pr Halimi, CHU
Grenoble Cedex 9, France, 38043

Sponsors and Collaborators

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

Investigators

Principal Investigator:	Pierre-Yves Benhamou, PhD	University Hospital, Grenoble

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Pr Pierre-Yves Benhamou, University Hospital Grenoble
ClinicalTrials.gov Identifier:	NCT00973492 History of Changes
Other Study ID Numbers:	2007-A00903-50
First Posted:	September 9, 2009
Last Update Posted:	September 9, 2009
Last Verified:	September 2009

Keywords provided by Association Grenobloise pour le Developpement D'etudes et de Recherches en Physiopathologie Endocrinienne, Diabetologie et Maladies de la Nutrition:

type 1 diabetes; functional insulinotherapy

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Glucose Metabolism Disorders; Metabolic Diseases	Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases